73 results on '"Vercammen C"'
Search Results
2. Lipohypertrophy monitoring study (LIMO): effect of injection site rotation and education on glycemic control
- Author
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Bochanen N., Decochez K., Heleu E., Cuypers J., Vercammen C., Coremans P., Vanhaverbeke G., Shadid S., Keymeulen B., Bolsens N., and De Block C
- Published
- 2021
3. Dapagliflozin and cardiovascular outcomes in type 2 diabetes
- Author
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Wiviott, S, Raz, I, Bonaca, M, Mosenzon, O, Kato, E, Cahn, A, Silverman, M, Zelniker, T, Kuder, J, Murphy, S, Bhatt, D, Leiter, L, Mcguire, D, Wilding, J, Ruff, C, Nilsson, G, Fredriksson, M, Johansson, P, Langkilde, A, Sabatine, M, Bansilal, S, Furtado, R, Fish, M, Gabovitch, D, Jevne, A, Ahern, S, Im, K, Goodrich, E, Lowe, C, Fisher, N, Gannon, J, Trindade, S, Towarowski, A, Fox, Y, Johnsson, E, Ranft, S, Faber, B, Wallander, M, Weiss, A, Buskila, A, Abola, M, Ardissino, D, Averkov, O, Aylward, P, Bode, C, Bonnici, F, Bonora, E, Budaj, A, Cernea, S, Chiang, C, Cooper, M, Dalby, A, Deerochanawong, C, Dellborg, M, Diaz, R, Dimulescu, D, Eliaschewitz, F, Goudev, A, Hadjadj, S, Herrera, M, Huo, Y, Jermendy, G, Ji, L, Kadowaki, T, Kiss, R, Kooy, A, Kumar, K, Lewis, B, Litwak, L, Lopez-Sendon, J, Ma, R, Merlini, P, Nauck, M, Nguyen, T, Nicolau, J, Ostgren, C, Ophuis, T, Padilla, F, Pais, P, Park, K, Parkhomenko, A, Ray, K, Rosenstock, J, Ruda, M, Satman, I, Shestakova, M, Smahelova, A, Spinar, J, Strojek, K, Sy, R, Tankova, T, Theroux, P, Tkac, I, Van Gaal, L, Wainstein, J, Harrington, R, Droller, M, Lee, K, Nesto, R, Tuomilehto, J, Hedlin, H, Desai, M, Sayfer, I, Alexanian, S, Awtry, E, Bentley-Lewis, R, Berger, C, Croce, K, Desai, A, Garg, R, Gelfand, E, Gignac, G, Goessling, W, Ho, C, Hochberg, E, Lane, A, Larrey, D, Leeman, D, Lewis, J, Link, M, Mcdonnell, M, Norden, A, Pande, A, Rosenberg, C, Rost, N, Ruberg, F, Schiff, E, Silverman, S, Singhal, A, Wagner, A, Wolpin, B, Aizenberg, D, Fernandez, M, Sala, J, Maffei, L, Luquez, C, Waitman, J, Rista, L, Nardone, L, Sposetti, G, Cantero, M, Alvarisqueta, A, Montana, O, Cuadrado, J, Cartasegna, L, Baccaro, C, Chertkoff, A, Sanabria, H, Vainstein, N, Amerena, J, Arya, K, D'Emden, M, Proietto, J, Moses, R, Colquhoun, D, Stranks, S, Lehman, R, Hamilton, A, Whelan, A, Simpson, R, Purnell, P, Abhayaratna, W, Hammett, C, Mckeirnan, M, Sullivan, D, Bach, L, Hughes, K, Mathieu, C, Vercammen, C, Scheen, A, Duyck, F, Cools, F, De Wolf, L, Verhaegen, A, Nobels, F, Missault, L, Crenier, L, Thoeng, J, Wollaert, B, Vandenbroucke, M, Borges, J, Turatti, L, Lima, F, dos Santos, F, Kerr Saraiva, J, Pereira, M, Pereira, A, Precoma, D, Filho, G, Reis, G, Maia, L, Bacheva, T, Temelkova-Kurktschiev, T, Maneva, S, Stoyanovska, B, Boshnyashka, R, Stoykova, Y, Georgiev, D, Tagarev, Z, Dimitrova, E, Vitkina, M, Yordanova, L, Temelkova, M, Vasileva, S, Kuneva, T, Zyumbyuleva, M, Daskalova, I, Genadieva, V, Boyanov, L, Farah, G, Lazarova, G, Georgieva, M, Krasteva, S, Slavcheva, A, Yabroudi, N, Veleva, N, Zlateva, A, Damyanova, V, Elenkova, A, Kotselova, T, Genov, K, Lyubenova, L, Temelkova, N, Harizanova, B, Zaharieva, S, Bajaj, H, Goldenberg, R, Aronson, R, Twum-Barima, D, Dumas, R, Kouz, S, Kaiser, S, Ajala, B, Cha, J, Teitelbaum, I, Chouinard, G, Woo, V, Dan Dattani, I, Mazza, G, Gaudet, D, Poirier, P, Conway, J, Dion, D, Mckeough, M, Manyari, D, Harris, S, St-Pierre, B, Yale, J, Landry, D, Gupta, M, Hramiak, I, Lau, D, Degrace, M, Gallo, R, Montigny, M, Dzongowski, P, Liutkus, J, Frechette, A, Gosselin, G, Sabbah, E, Langlois, M, Rabasa-Lhoret, R, Bedard, J, Hart, R, Dowell, A, Pandey, A, O'Keefe, D, Hill, L, Weisnagel, S, Muirhead, N, Zimmermann, R, Galiwango, P, Tobe, S, Priestman, B, Zinman, B, Ma, J, Zhao, X, Wang, C, Zhang, A, Dong, Y, Dong, X, Luo, M, Guo, J, Zheng, Z, Li, Y, Liang, Y, Peng, D, Maderic, D, Spinarova, L, Raclavska, L, Ludka, O, Rihacek, I, Karasova, J, Pelikanova, M, Vlasakova, H, Urbancova, K, Zamrazil, V, Hradec, J, Vlasicova, H, Racicka, E, Okenka, L, Naplava, R, Skopecek, J, Palova, S, Krystl, T, Pistek, Z, Oznerova, M, Andresova, A, Sarbochova, R, Taborska, P, Petrova, I, Stanek, L, Reichert, P, Lorenc, Z, Szabo, M, Petit, C, Krempf, M, Boye, A, Dubois, S, Clavel, S, Gourdy, P, Elbaz, M, Jazayeri, S, Gouet, D, Verges, B, Couffinhal, T, Sendeski, M, Klausmann, G, Appel, K, Pein, M, Thieme, R, Schumm-Draeger, P, Jacob, S, Toursarkissian, N, Kleinecke-Pohl, U, Tschope, D, Ott, P, Haak, T, Derwahl, K, Bugger, H, Hui, G, Tsang, C, Zilahi, Z, Puski, L, Vangel, S, Fulop, T, Pall, K, Hidvegi, T, Revesz, K, Koranyi, L, Kajetan, M, Kerenyi, Z, Penzes, J, Herczeg, B, Laszloczky, A, Turi, T, Rapi, J, Pentek, Z, Gaal, Z, Winkler, G, Percs, E, Czigany, A, Harcsa, E, Gurzo, M, Tassaly, J, Horthy, R, Petro, G, Farago, K, Muller, G, Varju, I, Kirschner, R, Kiss, I, Bakai, J, Kancz, S, Marton, Z, Kodur, R, Yajnik, C, Thomas, N, Ayyar, V, Iyengar, P, Bashkin, A, Daoud, D, Itzhak, B, Katz, A, Tsur, A, Nikolsky, E, Atar, S, Grossman, A, Klainman, E, Tsalihin, D, Shotan, A, Turgeman, Y, Ferrario, M, Piatti, P, Zenari, L, Trevisan, R, Bosco, B, Di Lorenzo, L, Mannucci, E, Avogaro, A, Reimers, B, Trimarco, B, Silvestri, O, Salvioni, A, Nakagawa, H, Sueyoshi, A, Fukuda, K, Yasumoto, H, Matsubayashi, S, Kawajiri, K, Togashi, Y, Senokuchi, T, Ohta, Y, Yamauchi, T, Node, K, Alcocer Gamba, M, Herrera Marmolejo, M, De los Rios Ibarra, M, Gonzalez Galvez, G, Garcia Cantu, E, Leguizamo Dimas, A, Luna Ceballos, R, Medina Pech, C, Stobschinski de Alba, C, Gonzalez Gonzalez, J, Padilla Padilla, F, Fanghanel Salmon, G, Robles Torres, F, Lopez Rosas, E, Pelayo Orozco, E, Banda Elizondo, R, Escalona Caamano, A, Frenk Baron, P, Aguilar Salinas, C, Mustieles Rocha, C, Vidrio Velazquez, M, Rodriguez Briones, I, Saldate Alonso, M, Velasco Sanchez, R, Groenemeijer, B, Ronner, E, Kuijper, A, Strikwerda, S, Van Kempen, W, Gijsbers, S, Oude Ophuis, A, Swart, H, Hoogenberg, K, Hovens, M, van Hessen, M, Westerink, J, Kragten, J, Nierop, P, Bax, W, Hartong, S, Nieuwdorp, M, Gonkel, F, Al Windy, N, Troquay, R, Schaafsma, H, Lieverse, A, Knufman, N, Tirador, L, Guenon, M, Ferrolino, A, Atilano, A, Aportadera, M, Que, M, Denopol, M, Tolentino, M, Jimeno, C, Wee, J, Mirasol, R, Panelo, A, Roxas, D, Palmes, P, Silva, A, Salvador, D, Rosita, R, Maravilla, L, Rogelio, G, Pacheco, E, Tin Hay, L, Prado, J, Krzyzagorska, E, Witek, R, Miklaszewicz, B, Sudnik, W, Pomiecko, W, Bochenek, A, Fares, I, Wujkowski, M, Korol, M, Powierza, S, Goch, A, Miekus, P, Siegel, A, Skierkowska, J, Romanczuk, P, Cygler, J, Landa, K, Szyprowska, E, Stachlewski, P, Czerski, T, Pawlowicz, L, Sowinski, D, Romanowski, L, Rudzki, H, Skorski, M, Jasiel-Wojculewicz, H, Stasiewski, A, Kania, G, Mirek-Bryniarska, E, Wojnowski, L, Korzeniak, R, Oh, T, Lee, M, Jang, H, Kim, S, Ku, B, Cha, B, Son, H, Lee, I, Park, J, Yu, S, Shon, H, Rhee, E, Cho, J, Park, T, Nam, J, Pintilei, E, Popescu, A, Nafornita, V, Gutu, O, Dumitrescu, A, Bala, C, Caceaune, E, Mindrescu, N, Morosanu, M, Bradescu, O, Munteanu, M, Voitec, M, Vlaiculescu, M, Hancu, N, Diaconu Sotropa, M, Lupu, S, Mateescu, A, Carlan, L, Marton, R, Lupusoru, D, Mot, A, Coman, A, Zaharie, D, Rebrov, A, Shutemova, E, Bolieva, L, Khalimov, Y, Statsenko, M, Galyavich, A, Koziolova, N, Shapovalova, Y, Pavlysh, E, Strongin, L, Vertkin, A, Vishneva, E, Pavlova, M, Khasanov, N, Antsiferov, M, Gavrisheva, I, Sokolova, N, Vorobyev, S, Morugova, T, Sinitsina, I, Ezhov, A, Kobalava, Z, Belenkiy, D, Supryadkina, T, Kazakov, Y, Oschepkova, E, Dreval, A, Novikova, T, Vishnevsky, A, Chizhov, D, Akatova, E, Vorokhobina, N, Ivanov, I, Dudinskaya, E, Konstantinov, V, Kanderkova, D, Pavlik, L, Raslova, K, Paulovic, V, Babikova, J, Belesova, K, Merciakova, M, Truban, J, Vargova, A, Fabryova, L, Slovenska, M, Plasil, R, Tomasova, L, Kollarova, D, Spodniakova, D, Kosikova, M, Dzuponova, J, Kurcova, I, Skripova, D, Gabrisova, A, Kalinova, S, Ranjith, N, Burgess, L, Mitha, I, Conradie, M, Distiller, L, Pillai, P, Pillay, S, Horak, A, Nethononda, R, van den Berg, E, Nortje, H, Bayat, J, Corbett, C, Abelson, M, van Zyl, L, Pillay, T, Wing, J, Kapp, C, Hidalgo Urbano, R, Gonzalez Juanatey, J, Blanco Coronado, J, Bruguera Cortada, J, Ferreiro Gutierrez, J, Quesada Simon, M, Castro, A, Delgado Alvarez, E, Freixa, R, Boada, A, Larnefeldt, H, Mooe, T, Koskinen, P, Lagerback, P, Linderfalk, C, Liu, B, Berndtsson Blom, K, Tengmark, B, Lindholm, C, Oweling, M, Albertsson, P, Alvarsson, M, Fant, S, Berglund, O, Hsia, C, Fang, C, Ueng, K, Wang, K, Lai, W, Mamanasiri, S, Wongvipaporn, C, Kuanprasert, S, Thongsri, T, Srimahachota, S, Boonyavarakul, A, Suwanwalaikorn, S, Tantiwong, P, Sritara, P, Sriwijitkamol, A, Sanguanwong, S, Chotinaiwattarakul, C, Piyayotai, D, Balci, M, Orbay, E, Saygili, F, Oguz, A, Altuntas, Y, Comlekci, A, Karpenko, O, Tkach, S, Vlasenko, M, Fushtey, I, Pertseva, T, Reshotko, D, Mostovoy, Y, Vizir, V, Kraiz, I, Amosova, K, Batushkin, V, Tseluyko, V, Koval, O, Strang, C, Bodalia, B, Pieters, R, Turner, W, Asamoah-Owusu, N, White, C, Calvert, J, Mcnally, D, Jones, N, Mckaig, G, Thompson, J, Mohr, S, Simpson, H, Conn, P, Mccoye, A, Rivero, O, Yazdani, S, Ince, C, Zeitlin, J, Wharton, T, Platt, G, Anderson, R, Angueira-Serrano, E, Lillestol, M, Hanlon, B, Soufer, J, Garcia, B, Iteld, B, Venugopal, C, Ahmed, A, Duardo-Guerra, Y, Jetty, P, Miranda, A, Wahlen, J, Lederman, S, Cohen, K, Lake, L, French, W, Tahirkheli, N, Baker, S, Stoltz, R, Wilson, J, Nadar, V, Brown, J, Larrain, G, Wiseman, A, Ruoff, G, Williams, M, Tan, A, Hartman, I, Singh, N, Graf, R, Wakefield, P, Mcneill, R, Byars, W, Reyes Almodovar, R, Jones, S, Kantaros, L, Hegedosh, N, Graves, M, Bernstein, M, Falkowski, S, Bialow, M, Paraschos, A, Dagher, G, Arif, A, Condit, J, Chaykin, L, Grunstra, B, Earl, J, Unks, D, Srivastava, S, Benson, M, Huffman, C, Miller, G, Willis, J, Bender, K, Martin, E, Blackmore, R, Rohr, K, Chilka, S, Gadowski, G, Fitz-Patrick, D, Benjamin, S, Morin, D, Zias Dilena, A, Acosta, R, Claassen, D, Miranda, F, Raad, G, Inzerello, A, Porter, J, Bhattacharya, A, Gutmann, J, Korpas, D, Syed, M, Zieve, F, Raisinghani, A, Alam, S, Bartkowiak, A, Boccalandro, F, Talano, J, Mercado, A, Krichmar, P, Oldfield, C, Adams, K, Gorman, T, Lewis, D, Shah, R, Shockey, G, Lefebvre, G, Andrawis, N, Tami, L, Bittar, N, Khan, M, Rink, L, Hendrix, E, Wood, J, Robinson, J, Pavon, H, Irfan, M, Gonzalez, E, Singal, R, Shore, K, Saba, F, Bianco, J, Erickson, B, Gorson, D, Puri, S, Arauz-Pacheco, C, Forman, S, Akyea-Djamson, A, Lieber, I, Barker, B, Desai, P, Sotolongo, C, Steinhoff, J, Hill, R, Radin, M, Patel, R, Lieberman, S, Wenocur, H, Dagogo-Jack, S, Lupovitch, S, Ison, R, Bacharach, J, Diogo, J, Mazzella, M, Greenwald, J, Quadrel, M, Mayer, N, Datu, J, Mccartney, M, Bruce, T, Singal, D, Turner, J, Videau, B, Fritz, R, Fox, D, Calatayud, G, Sheldon, W, Kereiakes, D, Thomas, J, Salacata, A, Mccullum, K, Harris, B, de Souza, J, Rahman, A, Blumenthal, S, Narayan, P, Bloch, M, Augenbraun, C, Bernstein, R, Perlman, R, Berman, J, Labryer, L, Wynne, A, Fish, J, Zarich, S, Gabra, N, Popeil, L, Hermany, P, Barreto, A, Pomposini, D, Gonzalez-Campoy, J, Langer, M, Bayron, C, Suneja, R, Kamlet, J, Wheeler, K, Hurley, S, Sharma, S, Wefald, F, Hershon, K, O'Connor, T, Pueblitz, G, Laguerre, J, Amin, M, Alfonso, T, Jaffrani, N, Isserman, S, Portnay, E, Vlastaris, A, Dy, J, Hagan, M, Noveck, H, Kraft, P, Andersen, J, Foley, B, Carr, K, Gelormini, J, Williams, T, Landau, C, Richwine, R, Thakkar, M, Karim, A, Madhun, Z, Francyk, D, Lamantia, J, Baker, B, Zhang, W, Lev, V, Hasan, M, Captain, A, Herzog, W, Friedman, K, Lawson, W, Desai, V, Ow, C, Simons, R, Mandviwala, M, Le, T, Hack, T, Zebrack, J, Henderson, D, Dejulia, J, Mehta, R, Reza, S, Poonawala, R, Awad, A, Velasquez, M, Mohiuddin, S, Salazar Sharma, M, Myrick, G, Gottlieb, D, Ovalle, F, Alfieri, A, Ahmed, S, Bohula, E, Donahoe, S, Longshaw, K, Eshaghian, S, Lash, J, Goldberg, R, Fox, B, Mostel, E, Dobies, D, Ward, H, Burbano, J, Puleo, P, Lenhard, M, Korn, D, Thadani, U, Bradley, A, Kmetzo, J, Heasley, E, Raikhel, M, Mahr, N, Bittar, G, Fuentes, F, Raghu, P, Diep, T, Tran, Q, Tran, N, Nguyen, D, Nguyen, V, Wiviott S. D., Raz I., Bonaca M. P., Mosenzon O., Kato E. T., Cahn A., Silverman M. G., Zelniker T. A., Kuder J. F., Murphy S. A., Bhatt D. L., Leiter L. A., McGuire D. K., Wilding J. P. H., Ruff C. T., Nilsson G. I., Fredriksson M., Johansson P. A., Langkilde A. M., Sabatine M. S., Bansilal S., Furtado R., Fish M. P., Gabovitch D., Jevne A., Ahern S., Im K., Goodrich E. L., Lowe C., Fisher N., Gannon J., Trindade S., Towarowski A., Fox Y., Johnsson E., Ranft S., Faber B., Wallander M., Weiss A., Buskila A., Abola M. T. B., Ardissino D., Averkov O., Aylward P., Bode C., Bonnici F., Bonora E., Budaj A. J., Cernea S., Chiang C. E., Cooper M., Dalby A., Deerochanawong C., Dellborg M., Diaz R., Dimulescu D., Eliaschewitz F. G., Goudev A. R., Hadjadj S., Herrera M., Huo Y., Jermendy G., Ji L., Kadowaki T., Kiss R., Kooy A., Kumar K. M. P., Lewis B., Litwak L., Lopez-Sendon J., Ma R., Merlini P. A., Nauck M. A., Nguyen T. K., Nicolau J. C., Ostgren C. J., Ophuis T. O., Padilla F., Pais P., Park K. S., Parkhomenko A., Ray K., Rosenstock J., Ruda M., Satman I., Shestakova M., Smahelova A., Spinar J., Strojek K., Sy R., Tankova T., Theroux P., Tkac I., Van Gaal L., Wainstein J., Harrington R. A., Droller M. J., Lee K. L., Nesto R. W., Tuomilehto J., Hedlin H., Desai M., Sayfer I., Alexanian S., Awtry E., Bentley-Lewis R., Berger C. J., Croce K., Desai A., Garg R. K., Gelfand E., Gignac G., Goessling W., Ho C., Hochberg E., Lane A., Larrey D., Leeman D. E., Lewis J., Link M. S., McDonnell M. E., Norden A. D., Pande A., Rosenberg C., Rost N., Ruberg F., Schiff E., Silverman S., Singhal A., Wagner A., Wolpin B., Aizenberg D., Fernandez M., Sala J., Maffei L., Luquez C., Waitman J., Rista L., Nardone L., Sposetti G., Cantero M., Alvarisqueta A., Montana O., Cuadrado J., Cartasegna L., Baccaro C., Chertkoff A., Sanabria H., Vainstein N., Amerena J., Arya K., d'Emden M., Proietto J., Moses R., Colquhoun D., Stranks S., Lehman R., Hamilton A., Whelan A., Simpson R., Purnell P., Abhayaratna W., Hammett C., McKeirnan M., Sullivan D., Bach L., Hughes K., Mathieu C., Vercammen C., Scheen A., Duyck F., Cools F., De Wolf L., Verhaegen A., Nobels F., Missault L., Crenier L., Thoeng J., Wollaert B., Vandenbroucke M., Eliaschewitz F., Borges J. L. C., Turatti L., Lima F. G., dos Santos F., Kerr Saraiva J., Pereira M., Pereira A., Precoma D. B., Filho G. F. V., Reis G., Maia L. N., Bacheva T., Temelkova-Kurktschiev T., Maneva S., Stoyanovska B., Boshnyashka R., Stoykova Y., Georgiev D., Tagarev Z., Dimitrova E., Vitkina M., Yordanova L., Temelkova M., Vasileva S., Kuneva T., Zyumbyuleva M., Daskalova I., Genadieva V., Boyanov L., Farah G., Lazarova G., Georgieva M., Krasteva S., Slavcheva A., Yabroudi N., Veleva N., Zlateva A., Damyanova V., Elenkova A., Kotselova T., Genov K., Lyubenova L., Temelkova N., Harizanova B., Zaharieva S., Bajaj H., Goldenberg R., Aronson R., Twum-Barima D., Dumas R., Kouz S., Kaiser S. M., Ajala B., Cha J., Teitelbaum I., Chouinard G., Woo V., Dan Dattani I., Mazza G., Gaudet D., Poirier P., Conway J., Dion D., McKeough M., Manyari D., Harris S., St-Pierre B., Yale J. F., Landry D., Gupta M., Hramiak I., Lau D., DeGrace M., Gallo R., Montigny M., Dzongowski P., Liutkus J., Frechette A., Gosselin G., Sabbah E., Langlois M. F., Rabasa-Lhoret R., Bedard J., Hart R., Dowell A., Pandey A., O'Keefe D., Hill L., Weisnagel S. J., Muirhead N., Zimmermann R., Galiwango P., Tobe S., Priestman B., Zinman B., Ma J., Zhao X., Wang C., Zhang A., Dong Y., Dong X., Luo M., Guo J., Zheng Z., Li Y., Liang Y., Peng D., Maderic D., Spinarova L., Raclavska L., Ludka O., Rihacek I., Karasova J., Pelikanova M., Vlasakova H., Urbancova K., Zamrazil V., Hradec J., Vlasicova H., Racicka E., Okenka L., Naplava R., Skopecek J., Palova S., Krystl T., Pistek Z., Oznerova M., Andresova A., Sarbochova R., Taborska P., Petrova I., Stanek L., Reichert P., Lorenc Z., Szabo M., Petit C., Krempf M., Boye A., Dubois S., Clavel S., Gourdy P., Elbaz M., Jazayeri S., Gouet D., Verges B., Couffinhal T., Sendeski M., Klausmann G., Appel K., Pein M., Thieme R., Schumm-Draeger P., Jacob S., Toursarkissian N., Kleinecke-Pohl U., Tschope D., Ott P., Haak T., Nauck M., Derwahl K., Bugger H., Hui G., Tsang C., Zilahi Z., Puski L., Vangel S., Fulop T., Pall K., Hidvegi T., Revesz K., Koranyi L., Kajetan M., Kerenyi Z., Penzes J., Herczeg B., Laszloczky A., Turi T., Rapi J., Pentek Z., Gaal Z., Winkler G., Percs E., Czigany A., Harcsa E., Gurzo M., Tassaly J., Horthy R., Petro G., Farago K., Muller G., Varju I., Kirschner R., Kiss I., Bakai J., Kancz S., Marton Z., Kodur R., Yajnik C., Thomas N., Ayyar V., Iyengar P., Bashkin A., Daoud D., Itzhak B., Katz A., Tsur A., Nikolsky E., Atar S., Grossman A., Klainman E., Tsalihin D., Shotan A., Turgeman Y., Ferrario M., Merlini P., Piatti P., Zenari L., Trevisan R., Bosco B., Di Lorenzo L., Mannucci E., Avogaro A., Reimers B., Trimarco B., Silvestri O., Salvioni A., Nakagawa H., Sueyoshi A., Fukuda K., Yasumoto H., Matsubayashi S., Kawajiri K., Togashi Y., Senokuchi T., Ohta Y., Yamauchi T., Node K., Alcocer Gamba M., Herrera Marmolejo M., De los Rios Ibarra M., Gonzalez Galvez G., Garcia Cantu E., Leguizamo Dimas A., Luna Ceballos R., Medina Pech C., Stobschinski de Alba C., Gonzalez Gonzalez J., Padilla Padilla F., Fanghanel Salmon G., Robles Torres F., Lopez Rosas E., Pelayo Orozco E., Banda Elizondo R., Escalona Caamano A., Frenk Baron P., Aguilar Salinas C., Mustieles Rocha C., Vidrio Velazquez M., Rodriguez Briones I., Saldate Alonso M., Velasco Sanchez R., Groenemeijer B., Ronner E., Kuijper A., Strikwerda S., Van Kempen W., Gijsbers S., Oude Ophuis A., Swart H., Hoogenberg K., Hovens M., van Hessen M., Westerink J., Kragten J., Nierop P., Bax W., Hartong S., Nieuwdorp M., Gonkel F., Al Windy N., Troquay R., Schaafsma H., Lieverse A., Knufman N., Tirador L., Guenon M., Ferrolino A., Atilano A., Aportadera M., Que M., Denopol M., Tolentino M., Jimeno C., Wee J., Mirasol R., Panelo A., Roxas D., Abola M., Palmes P., Silva A., Salvador D., Rosita R., Maravilla L., Rogelio G., Pacheco E., Tin Hay L., Prado J., Krzyzagorska E., Witek R., Miklaszewicz B., Sudnik W., Pomiecko W., Bochenek A., Fares I., Wujkowski M., Korol M., Powierza S., Goch A., Miekus P., Siegel A., Skierkowska J., Romanczuk P., Cygler J., Landa K., Szyprowska E., Stachlewski P., Czerski T., Pawlowicz L., Sowinski D., Romanowski L., Rudzki H., Skorski M., Jasiel-Wojculewicz H., Stasiewski A., Budaj A., Kania G., Mirek-Bryniarska E., Wojnowski L., Korzeniak R., Oh T., Park K., Lee M., Lee K., Jang H., Kim S., Ku B., Cha B., Son H., Lee I., Park J., Yu S., Shon H., Rhee E., Cho J., Park T., Nam J., Pintilei E., Popescu A., Nafornita V., Gutu O., Dumitrescu A., Bala C., Caceaune E., Mindrescu N., Morosanu M., Bradescu O., Munteanu M., Voitec M., Vlaiculescu M., Hancu N., Diaconu Sotropa M., Lupu S., Mateescu A., Carlan L., Marton R., Lupusoru D., Mot A., Coman A., Zaharie D., Rebrov A., Shutemova E., Bolieva L., Khalimov Y., Statsenko M., Galyavich A., Koziolova N., Shapovalova Y., Pavlysh E., Strongin L., Vertkin A., Vishneva E., Pavlova M., Khasanov N., Antsiferov M., Gavrisheva I., Sokolova N., Vorobyev S., Morugova T., Sinitsina I., Ezhov A., Kobalava Z., Belenkiy D., Supryadkina T., Kazakov Y., Oschepkova E., Dreval A., Novikova T., Vishnevsky A., Chizhov D., Akatova E., Vorokhobina N., Ivanov I., Dudinskaya E., Konstantinov V., Kanderkova D., Pavlik L., Raslova K., Paulovic V., Babikova J., Belesova K., Merciakova M., Truban J., Vargova A., Fabryova L., Slovenska M., Plasil R., Tomasova L., Kollarova D., Spodniakova D., Kosikova M., Dzuponova J., Kurcova I., Skripova D., Gabrisova A., Kalinova S., Ranjith N., Burgess L., Mitha I., Conradie M., Distiller L., Pillai P., Pillay S., Horak A., Nethononda R., van den Berg E., Nortje H., Bayat J., Corbett C., Abelson M., van Zyl L., Pillay T., Wing J., Kapp C., Hidalgo Urbano R., Gonzalez Juanatey J., Blanco Coronado J., Bruguera Cortada J., Ferreiro Gutierrez J., Quesada Simon M., Castro A., Delgado Alvarez E., Freixa R., Boada A., Larnefeldt H., Mooe T., Koskinen P., Lagerback P., Linderfalk C., Liu B., Berndtsson Blom K., Tengmark B., Lindholm C., Ostgren C., Oweling M., Albertsson P., Alvarsson M., Fant S., Berglund O., Hsia C., Chiang C., Fang C., Ueng K., Wang K., Lai W., Mamanasiri S., Wongvipaporn C., Kuanprasert S., Thongsri T., Srimahachota S., Boonyavarakul A., Suwanwalaikorn S., Tantiwong P., Sritara P., Sriwijitkamol A., Sanguanwong S., Chotinaiwattarakul C., Piyayotai D., Balci M., Orbay E., Saygili F., Oguz A., Altuntas Y., Comlekci A., Karpenko O., Tkach S., Vlasenko M., Fushtey I., Pertseva T., Reshotko D., Mostovoy Y., Vizir V., Kraiz I., Amosova K., Batushkin V., Tseluyko V., Koval O., Strang C., Bodalia B., Pieters R., Turner W., Asamoah-Owusu N., White C., Calvert J., McNally D., Jones N., McKaig G., Thompson J., Mohr S., Simpson H., Conn P., McCoye A., Rivero O., Yazdani S., Ince C., Zeitlin J., Wharton T., Platt G., Anderson R. J., Angueira-Serrano E., Lillestol M., Hanlon B., Soufer J., Garcia B., Iteld B., Venugopal C., Ahmed A., Duardo-Guerra Y., Jetty P., Miranda A., Wahlen J., Lederman S., Cohen K., Lake L., French W. J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. S., Rink L., Hendrix E., Wood J., Robinson J., Pavon H., Irfan M., Gonzalez E., Singal R., Shore K., Saba F., Bianco J., Erickson B., Gorson D., Puri S., Arauz-Pacheco C., Forman S., Akyea-Djamson A., Lieber I., Barker B., Desai P., Sotolongo C., Steinhoff J., Hill R., Radin M., Patel R., Lieberman S., Wenocur H., Dagogo-Jack S., Lupovitch S., Ison R., Bacharach J. M., Diogo J., Mazzella M., Greenwald J., Quadrel M., Mayer N., Datu J., McCartney M., Bruce T., Singal D., Turner J., Videau B., Fritz R., Fox D., Calatayud G., Sheldon W., Kereiakes D., Thomas J., Salacata A., McCullum K., Harris B., de Souza J., Rahman A., Blumenthal S., Narayan P., Bloch M., Augenbraun C., Bernstein R., Perlman R., Berman J., LaBryer L., Wynne A., Fish J., Zarich S., Gabra N., Popeil L., Hermany P., Barreto A., Pomposini D., Gonzalez-Campoy J. M., Langer M., Bayron C., Suneja R., Kamlet J., Wheeler K., Hurley S., Sharma S., Wefald F., Hershon K., O'Connor T., Pueblitz G., Laguerre J., Amin M., Alfonso T., Jaffrani N., Isserman S., Portnay E., Vlastaris A., Dy J., Hagan M., Noveck H., Kraft P., Andersen J., Foley B., Carr K., Gelormini J., Williams T., Landau C., Richwine R., Thakkar M., Karim A., Madhun Z., Francyk D., Lamantia J., Baker B., Zhang W., Lev V., Hasan M., Captain A., Herzog W., Friedman K., Lawson W., Desai V., Ow C., Simons R., Mandviwala M., Le T., Hack T., Zebrack J., Henderson D., DeJulia J., Mehta R., Reza S., Poonawala R., Awad A., Velasquez M., Mohiuddin S., Salazar Sharma M., Myrick G., Gottlieb D., Ovalle F., Alfieri A., Ahmed S., Bohula E., Donahoe S. M., Longshaw K., Eshaghian S., Lash J., Goldberg R. K., Fox B., Mostel E., Dobies D., Ward H., Burbano J., Puleo P., Lenhard M. J., Korn D., Thadani U., Bradley A., Kmetzo J., Heasley E., Raikhel M., Mahr N., Bittar G., Fuentes F., Raghu P., Diep T. T. 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J., Angueira-Serrano E., Lillestol M., Hanlon B., Soufer J., Garcia B., Iteld B., Venugopal C., Ahmed A., Duardo-Guerra Y., Jetty P., Miranda A., Wahlen J., Lederman S., Cohen K., Lake L., French W. J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. S., Rink L., Hendrix E., Wood J., Robinson J., Pavon H., Irfan M., Gonzalez E., Singal R., Shore K., Saba F., Bianco J., Erickson B., Gorson D., Puri S., Arauz-Pacheco C., Forman S., Akyea-Djamson A., Lieber I., Barker B., Desai P., Sotolongo C., Steinhoff J., Hill R., Radin M., Patel R., Lieberman S., Wenocur H., Dagogo-Jack S., Lupovitch S., Ison R., Bacharach J. M., Diogo J., Mazzella M., Greenwald J., Quadrel M., Mayer N., Datu J., McCartney M., Bruce T., Singal D., Turner J., Videau B., Fritz R., Fox D., Calatayud G., Sheldon W., Kereiakes D., Thomas J., Salacata A., McCullum K., Harris B., de Souza J., Rahman A., Blumenthal S., Narayan P., Bloch M., Augenbraun C., Bernstein R., Perlman R., Berman J., LaBryer L., Wynne A., Fish J., Zarich S., Gabra N., Popeil L., Hermany P., Barreto A., Pomposini D., Gonzalez-Campoy J. M., Langer M., Bayron C., Suneja R., Kamlet J., Wheeler K., Hurley S., Sharma S., Wefald F., Hershon K., O'Connor T., Pueblitz G., Laguerre J., Amin M., Alfonso T., Jaffrani N., Isserman S., Portnay E., Vlastaris A., Dy J., Hagan M., Noveck H., Kraft P., Andersen J., Foley B., Carr K., Gelormini J., Williams T., Landau C., Richwine R., Thakkar M., Karim A., Madhun Z., Francyk D., Lamantia J., Baker B., Zhang W., Lev V., Hasan M., Captain A., Herzog W., Friedman K., Lawson W., Desai V., Ow C., Simons R., Mandviwala M., Le T., Hack T., Zebrack J., Henderson D., DeJulia J., Mehta R., Reza S., Poonawala R., Awad A., Velasquez M., Mohiuddin S., Salazar Sharma M., Myrick G., Gottlieb D., Ovalle F., Alfieri A., Ahmed S., Bohula E., Donahoe S. M., Longshaw K., Eshaghian S., Lash J., Goldberg R. K., Fox B., Mostel E., Dobies D., Ward H., Burbano J., Puleo P., Lenhard M. J., Korn D., Thadani U., Bradley A., Kmetzo J., Heasley E., Raikhel M., Mahr N., Bittar G., Fuentes F., Raghu P., Diep T. T. B., Tran Q. K., Tran N., Nguyen D., and Nguyen V.
- Abstract
BACKGROUND The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to ≥60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], ≥1.3; P≥0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P = 0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P = 0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87)
- Published
- 2019
4. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes
- Author
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Wiviott S. D., Raz I., Bonaca M. P., Mosenzon O., Kato E. T., Cahn A., Silverman M. G., Zelniker T. A., Kuder J. F., Murphy S. A., Bhatt D. L., Leiter L. A., McGuire D. K., Wilding J. P. H., Ruff C. T., Nilsson G. I., Fredriksson M., Johansson P. A., Langkilde A. M., Sabatine M. S., Bansilal S., Furtado R., Fish M. P., Gabovitch D., Jevne A., Ahern S., Im K., Goodrich E. L., Lowe C., Fisher N., Gannon J., Trindade S., Towarowski A., Fox Y., Johnsson E., Ranft S., Faber B., Wallander M., Weiss A., Buskila A., Abola M. T. B., Ardissino D., Averkov O., Aylward P., Bode C., Bonnici F., Bonora E., Budaj A. J., Cernea S., Chiang C. E., Cooper M., Dalby A., Deerochanawong C., Dellborg M., Diaz R., Dimulescu D., Eliaschewitz F. G., Goudev A. R., Hadjadj S., Herrera M., Huo Y., Jermendy G., Ji L., Kadowaki T., Kiss R., Kooy A., Kumar K. M. P., Lewis B., Litwak L., Lopez-Sendon J., Ma R., Merlini P. A., Nauck M. A., Nguyen T. K., Nicolau J. C., Ostgren C. J., Ophuis T. O., Padilla F., Pais P., Park K. S., Parkhomenko A., Ray K., Rosenstock J., Ruda M., Satman I., Shestakova M., Smahelova A., Spinar J., Strojek K., Sy R., Tankova T., Theroux P., Tkac I., Van Gaal L., Wainstein J., Harrington R. A., Droller M. J., Lee K. L., Nesto R. W., Tuomilehto J., Hedlin H., Desai M., Sayfer I., Alexanian S., Awtry E., Bentley-Lewis R., Berger C. J., Croce K., Desai A., Garg R. K., Gelfand E., Gignac G., Goessling W., Ho C., Hochberg E., Lane A., Larrey D., Leeman D. E., Lewis J., Link M. S., McDonnell M. E., Norden A. D., Pande A., Rosenberg C., Rost N., Ruberg F., Schiff E., Silverman S., Singhal A., Wagner A., Wolpin B., Aizenberg D., Fernandez M., Sala J., Maffei L., Luquez C., Waitman J., Rista L., Nardone L., Sposetti G., Cantero M., Alvarisqueta A., Montana O., Cuadrado J., Cartasegna L., Baccaro C., Chertkoff A., Sanabria H., Vainstein N., Amerena J., Arya K., d'Emden M., Proietto J., Moses R., Colquhoun D., Stranks S., Lehman R., Hamilton A., Whelan A., Simpson R., Purnell P., Abhayaratna W., Hammett C., McKeirnan M., Sullivan D., Bach L., Hughes K., Mathieu C., Vercammen C., Scheen A., Duyck F., Cools F., De Wolf L., Verhaegen A., Nobels F., Missault L., Crenier L., Thoeng J., Wollaert B., Vandenbroucke M., Eliaschewitz F., Borges J. L. C., Turatti L., Lima F. G., dos Santos F., Kerr Saraiva J., Pereira M., Pereira A., Precoma D. B., Filho G. F. V., Reis G., Maia L. N., Bacheva T., Temelkova-Kurktschiev T., Maneva S., Stoyanovska B., Boshnyashka R., Stoykova Y., Georgiev D., Tagarev Z., Dimitrova E., Vitkina M., Yordanova L., Temelkova M., Vasileva S., Kuneva T., Zyumbyuleva M., Daskalova I., Genadieva V., Boyanov L., Farah G., Lazarova G., Georgieva M., Krasteva S., Slavcheva A., Yabroudi N., Veleva N., Zlateva A., Damyanova V., Elenkova A., Kotselova T., Genov K., Lyubenova L., Temelkova N., Harizanova B., Zaharieva S., Bajaj H., Goldenberg R., Aronson R., Twum-Barima D., Dumas R., Kouz S., Kaiser S. M., Ajala B., Cha J., Teitelbaum I., Chouinard G., Woo V., Dan Dattani I., Mazza G., Gaudet D., Poirier P., Conway J., Dion D., McKeough M., Manyari D., Harris S., St-Pierre B., Yale J. F., Landry D., Gupta M., Hramiak I., Lau D., DeGrace M., Gallo R., Montigny M., Dzongowski P., Liutkus J., Frechette A., Gosselin G., Sabbah E., Langlois M. F., Rabasa-Lhoret R., Bedard J., Hart R., Dowell A., Pandey A., O'Keefe D., Hill L., Weisnagel S. J., Muirhead N., Zimmermann R., Galiwango P., Tobe S., Priestman B., Zinman B., Ma J., Zhao X., Wang C., Zhang A., Dong Y., Dong X., Luo M., Guo J., Zheng Z., Li Y., Liang Y., Peng D., Maderic D., Spinarova L., Raclavska L., Ludka O., Rihacek I., Karasova J., Pelikanova M., Vlasakova H., Urbancova K., Zamrazil V., Hradec J., Vlasicova H., Racicka E., Okenka L., Naplava R., Skopecek J., Palova S., Krystl T., Pistek Z., Oznerova M., Andresova A., Sarbochova R., Taborska P., Petrova I., Stanek L., Reichert P., Lorenc Z., Szabo M., Petit C., Krempf M., Boye A., Dubois S., Clavel S., Gourdy P., Elbaz M., Jazayeri S., Gouet D., Verges B., Couffinhal T., Sendeski M., Klausmann G., Appel K., Pein M., Thieme R., Schumm-Draeger P., Jacob S., Toursarkissian N., Kleinecke-Pohl U., Tschope D., Ott P., Haak T., Nauck M., Derwahl K., Bugger H., Hui G., Tsang C., Zilahi Z., Puski L., Vangel S., Fulop T., Pall K., Hidvegi T., Revesz K., Koranyi L., Kajetan M., Kerenyi Z., Penzes J., Herczeg B., Laszloczky A., Turi T., Rapi J., Pentek Z., Gaal Z., Winkler G., Percs E., Czigany A., Harcsa E., Gurzo M., Tassaly J., Horthy R., Petro G., Farago K., Muller G., Varju I., Kirschner R., Kiss I., Bakai J., Kancz S., Marton Z., Kodur R., Yajnik C., Thomas N., Ayyar V., Iyengar P., Bashkin A., Daoud D., Itzhak B., Katz A., Tsur A., Nikolsky E., Atar S., Grossman A., Klainman E., Tsalihin D., Shotan A., Turgeman Y., Ferrario M., Merlini P., Piatti P., Zenari L., Trevisan R., Bosco B., Di Lorenzo L., Mannucci E., Avogaro A., Reimers B., Trimarco B., Silvestri O., Salvioni A., Nakagawa H., Sueyoshi A., Fukuda K., Yasumoto H., Matsubayashi S., Kawajiri K., Togashi Y., Senokuchi T., Ohta Y., Yamauchi T., Node K., Alcocer Gamba M., Herrera Marmolejo M., De los Rios Ibarra M., Gonzalez Galvez G., Garcia Cantu E., Leguizamo Dimas A., Luna Ceballos R., Medina Pech C., Stobschinski de Alba C., Gonzalez Gonzalez J., Padilla Padilla F., Fanghanel Salmon G., Robles Torres F., Lopez Rosas E., Pelayo Orozco E., Banda Elizondo R., Escalona Caamano A., Frenk Baron P., Aguilar Salinas C., Mustieles Rocha C., Vidrio Velazquez M., Rodriguez Briones I., Saldate Alonso M., Velasco Sanchez R., Groenemeijer B., Ronner E., Kuijper A., Strikwerda S., Van Kempen W., Gijsbers S., Oude Ophuis A., Swart H., Hoogenberg K., Hovens M., van Hessen M., Westerink J., Kragten J., Nierop P., Bax W., Hartong S., Nieuwdorp M., Gonkel F., Al Windy N., Troquay R., Schaafsma H., Lieverse A., Knufman N., Tirador L., Guenon M., Ferrolino A., Atilano A., Aportadera M., Que M., Denopol M., Tolentino M., Jimeno C., Wee J., Mirasol R., Panelo A., Roxas D., Abola M., Palmes P., Silva A., Salvador D., Rosita R., Maravilla L., Rogelio G., Pacheco E., Tin Hay L., Prado J., Krzyzagorska E., Witek R., Miklaszewicz B., Sudnik W., Pomiecko W., Bochenek A., Fares I., Wujkowski M., Korol M., Powierza S., Goch A., Miekus P., Siegel A., Skierkowska J., Romanczuk P., Cygler J., Landa K., Szyprowska E., Stachlewski P., Czerski T., Pawlowicz L., Sowinski D., Romanowski L., Rudzki H., Skorski M., Jasiel-Wojculewicz H., Stasiewski A., Budaj A., Kania G., Mirek-Bryniarska E., Wojnowski L., Korzeniak R., Oh T., Park K., Lee M., Lee K., Jang H., Kim S., Ku B., Cha B., Son H., Lee I., Park J., Yu S., Shon H., Rhee E., Cho J., Park T., Nam J., Pintilei E., Popescu A., Nafornita V., Gutu O., Dumitrescu A., Bala C., Caceaune E., Mindrescu N., Morosanu M., Bradescu O., Munteanu M., Voitec M., Vlaiculescu M., Hancu N., Diaconu Sotropa M., Lupu S., Mateescu A., Carlan L., Marton R., Lupusoru D., Mot A., Coman A., Zaharie D., Rebrov A., Shutemova E., Bolieva L., Khalimov Y., Statsenko M., Galyavich A., Koziolova N., Shapovalova Y., Pavlysh E., Strongin L., Vertkin A., Vishneva E., Pavlova M., Khasanov N., Antsiferov M., Gavrisheva I., Sokolova N., Vorobyev S., Morugova T., Sinitsina I., Ezhov A., Kobalava Z., Belenkiy D., Supryadkina T., Kazakov Y., Oschepkova E., Dreval A., Novikova T., Vishnevsky A., Chizhov D., Akatova E., Vorokhobina N., Ivanov I., Dudinskaya E., Konstantinov V., Kanderkova D., Pavlik L., Raslova K., Paulovic V., Babikova J., Belesova K., Merciakova M., Truban J., Vargova A., Fabryova L., Slovenska M., Plasil R., Tomasova L., Kollarova D., Spodniakova D., Kosikova M., Dzuponova J., Kurcova I., Skripova D., Gabrisova A., Kalinova S., Ranjith N., Burgess L., Mitha I., Conradie M., Distiller L., Pillai P., Pillay S., Horak A., Nethononda R., van den Berg E., Nortje H., Bayat J., Corbett C., Abelson M., van Zyl L., Pillay T., Wing J., Kapp C., Hidalgo Urbano R., Gonzalez Juanatey J., Blanco Coronado J., Bruguera Cortada J., Ferreiro Gutierrez J., Quesada Simon M., Castro A., Delgado Alvarez E., Freixa R., Boada A., Larnefeldt H., Mooe T., Koskinen P., Lagerback P., Linderfalk C., Liu B., Berndtsson Blom K., Tengmark B., Lindholm C., Ostgren C., Oweling M., Albertsson P., Alvarsson M., Fant S., Berglund O., Hsia C., Chiang C., Fang C., Ueng K., Wang K., Lai W., Mamanasiri S., Wongvipaporn C., Kuanprasert S., Thongsri T., Srimahachota S., Boonyavarakul A., Suwanwalaikorn S., Tantiwong P., Sritara P., Sriwijitkamol A., Sanguanwong S., Chotinaiwattarakul C., Piyayotai D., Balci M., Orbay E., Saygili F., Oguz A., Altuntas Y., Comlekci A., Karpenko O., Tkach S., Vlasenko M., Fushtey I., Pertseva T., Reshotko D., Mostovoy Y., Vizir V., Kraiz I., Amosova K., Batushkin V., Tseluyko V., Koval O., Strang C., Bodalia B., Pieters R., Turner W., Asamoah-Owusu N., White C., Calvert J., McNally D., Jones N., McKaig G., Thompson J., Mohr S., Simpson H., Conn P., McCoye A., Rivero O., Yazdani S., Ince C., Zeitlin J., Wharton T., Platt G., Anderson R. J., Angueira-Serrano E., Lillestol M., Hanlon B., Soufer J., Garcia B., Iteld B., Venugopal C., Ahmed A., Duardo-Guerra Y., Jetty P., Miranda A., Wahlen J., Lederman S., Cohen K., Lake L., French W. J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. S., Rink L., Hendrix E., Wood J., Robinson J., Pavon H., Irfan M., Gonzalez E., Singal R., Shore K., Saba F., Bianco J., Erickson B., Gorson D., Puri S., Arauz-Pacheco C., Forman S., Akyea-Djamson A., Lieber I., Barker B., Desai P., Sotolongo C., Steinhoff J., Hill R., Radin M., Patel R., Lieberman S., Wenocur H., Dagogo-Jack S., Lupovitch S., Ison R., Bacharach J. M., Diogo J., Mazzella M., Greenwald J., Quadrel M., Mayer N., Datu J., McCartney M., Bruce T., Singal D., Turner J., Videau B., Fritz R., Fox D., Calatayud G., Sheldon W., Kereiakes D., Thomas J., Salacata A., McCullum K., Harris B., de Souza J., Rahman A., Blumenthal S., Narayan P., Bloch M., Augenbraun C., Bernstein R., Perlman R., Berman J., LaBryer L., Wynne A., Fish J., Zarich S., Gabra N., Popeil L., Hermany P., Barreto A., Pomposini D., Gonzalez-Campoy J. M., Langer M., Bayron C., Suneja R., Kamlet J., Wheeler K., Hurley S., Sharma S., Wefald F., Hershon K., O'Connor T., Pueblitz G., Laguerre J., Amin M., Alfonso T., Jaffrani N., Isserman S., Portnay E., Vlastaris A., Dy J., Hagan M., Noveck H., Kraft P., Andersen J., Foley B., Carr K., Gelormini J., Williams T., Landau C., Richwine R., Thakkar M., Karim A., Madhun Z., Francyk D., Lamantia J., Baker B., Zhang W., Lev V., Hasan M., Captain A., Herzog W., Friedman K., Lawson W., Desai V., Ow C., Simons R., Mandviwala M., Le T., Hack T., Zebrack J., Henderson D., DeJulia J., Mehta R., Reza S., Poonawala R., Awad A., Velasquez M., Mohiuddin S., Salazar Sharma M., Myrick G., Gottlieb D., Ovalle F., Alfieri A., Ahmed S., Bohula E., Donahoe S. M., Longshaw K., Eshaghian S., Lash J., Goldberg R. K., Fox B., Mostel E., Dobies D., Ward H., Burbano J., Puleo P., Lenhard M. J., Korn D., Thadani U., Bradley A., Kmetzo J., Heasley E., Raikhel M., Mahr N., Bittar G., Fuentes F., Raghu P., Diep T. T. 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C, Wee, J, Mirasol, R, Panelo, A, Roxas, D, Palmes, P, Silva, A, Salvador, D, Rosita, R, Maravilla, L, Rogelio, G, Pacheco, E, Tin Hay, L, Prado, J, Krzyzagorska, E, Witek, R, Miklaszewicz, B, Sudnik, W, Pomiecko, W, Bochenek, A, Fares, I, Wujkowski, M, Korol, M, Powierza, S, Goch, A, Miekus, P, Siegel, A, Skierkowska, J, Romanczuk, P, Cygler, J, Landa, K, Szyprowska, E, Stachlewski, P, Czerski, T, Pawlowicz, L, Sowinski, D, Romanowski, L, Rudzki, H, Skorski, M, Jasiel-Wojculewicz, H, Stasiewski, A, Kania, G, Mirek-Bryniarska, E, Wojnowski, L, Korzeniak, R, Oh, T, Lee, M, Jang, H, Kim, S, Ku, B, Cha, B, Son, H, Lee, I, Park, J, Yu, S, Shon, H, Rhee, E, Cho, J, Park, T, Nam, J, Pintilei, E, Popescu, A, Nafornita, V, Gutu, O, Dumitrescu, A, Bala, C, Caceaune, E, Mindrescu, N, Morosanu, M, Bradescu, O, Munteanu, M, Voitec, M, Vlaiculescu, M, Hancu, N, Diaconu Sotropa, M, Lupu, S, Mateescu, A, Carlan, L, Marton, R, Lupusoru, D, Mot, A, Coman, A, Zaharie, D, Rebrov, A, Shutemova, E, Bolieva, L, Khalimov, Y, Statsenko, M, Galyavich, A, Koziolova, N, Shapovalova, Y, Pavlysh, E, Strongin, L, Vertkin, A, Vishneva, E, Pavlova, M, Khasanov, N, Antsiferov, M, Gavrisheva, I, Sokolova, N, Vorobyev, S, Morugova, T, Sinitsina, I, Ezhov, A, Kobalava, Z, Belenkiy, D, Supryadkina, T, Kazakov, Y, Oschepkova, E, Dreval, A, Novikova, T, Vishnevsky, A, Chizhov, D, Akatova, E, Vorokhobina, N, Ivanov, I, Dudinskaya, E, Konstantinov, V, Kanderkova, D, Pavlik, L, Raslova, K, Paulovic, V, Babikova, J, Belesova, K, Merciakova, M, Truban, J, Vargova, A, Fabryova, L, Slovenska, M, Plasil, R, Tomasova, L, Kollarova, D, Spodniakova, D, Kosikova, M, Dzuponova, J, Kurcova, I, Skripova, D, Gabrisova, A, Kalinova, S, Ranjith, N, Burgess, L, Mitha, I, Conradie, M, Distiller, L, Pillai, P, Pillay, S, Horak, A, Nethononda, R, van den Berg, E, Nortje, H, Bayat, J, Corbett, C, Abelson, M, van Zyl, L, Pillay, T, Wing, J, Kapp, C, Hidalgo Urbano, R, Gonzalez Juanatey, J, Blanco Coronado, J, Bruguera Cortada, J, Ferreiro Gutierrez, J, Quesada Simon, M, Castro, A, Delgado Alvarez, E, Freixa, R, Boada, A, Larnefeldt, H, Mooe, T, Koskinen, P, Lagerback, P, Linderfalk, C, Liu, B, Berndtsson Blom, K, Tengmark, B, Lindholm, C, Oweling, M, Albertsson, P, Alvarsson, M, Fant, S, Berglund, O, Hsia, C, Fang, C, Ueng, K, Wang, K, Lai, W, Mamanasiri, S, Wongvipaporn, C, Kuanprasert, S, Thongsri, T, Srimahachota, S, Boonyavarakul, A, Suwanwalaikorn, S, Tantiwong, P, Sritara, P, Sriwijitkamol, A, Sanguanwong, S, Chotinaiwattarakul, C, Piyayotai, D, Balci, M, Orbay, E, Saygili, F, Oguz, A, Altuntas, Y, Comlekci, A, Karpenko, O, Tkach, S, Vlasenko, M, Fushtey, I, Pertseva, T, Reshotko, D, Mostovoy, Y, Vizir, V, Kraiz, I, Amosova, K, Batushkin, V, Tseluyko, V, Koval, O, Strang, C, Bodalia, B, Pieters, R, Turner, W, Asamoah-Owusu, N, White, C, Calvert, J, Mcnally, D, Jones, N, Mckaig, G, Thompson, J, Mohr, S, Simpson, H, Conn, P, Mccoye, A, Rivero, O, Yazdani, S, Ince, C, Zeitlin, J, Wharton, T, Platt, G, Anderson, R, Angueira-Serrano, E, Lillestol, M, Hanlon, B, Soufer, J, Garcia, B, Iteld, B, Venugopal, C, Ahmed, A, Duardo-Guerra, Y, Jetty, P, Miranda, A, Wahlen, J, Lederman, S, Cohen, K, Lake, L, French, W, Tahirkheli, N, Baker, S, Stoltz, R, Wilson, J, Nadar, V, Brown, J, Larrain, G, Wiseman, A, Ruoff, G, Williams, M, Tan, A, Hartman, I, Singh, N, Graf, R, Wakefield, P, Mcneill, R, Byars, W, Reyes Almodovar, R, Jones, S, Kantaros, L, Hegedosh, N, Graves, M, Bernstein, M, Falkowski, S, Bialow, M, Paraschos, A, Dagher, G, Arif, A, Condit, J, Chaykin, L, Grunstra, B, Earl, J, Unks, D, Srivastava, S, Benson, M, Huffman, C, Miller, G, Willis, J, Bender, K, Martin, E, Blackmore, R, Rohr, K, Chilka, S, Gadowski, G, Fitz-Patrick, D, Benjamin, S, Morin, D, Zias Dilena, A, Acosta, R, Claassen, D, Miranda, F, Raad, G, Inzerello, A, Porter, J, Bhattacharya, A, Gutmann, J, Korpas, D, Syed, M, Zieve, F, Raisinghani, A, Alam, S, Bartkowiak, A, Boccalandro, F, Talano, J, Mercado, A, Krichmar, P, Oldfield, C, Adams, K, Gorman, T, Lewis, D, Shah, R, Shockey, G, Lefebvre, G, Andrawis, N, Tami, L, Bittar, N, Khan, M, Rink, L, Hendrix, E, Wood, J, Robinson, J, Pavon, H, Irfan, M, Gonzalez, E, Singal, R, Shore, K, Saba, F, Bianco, J, Erickson, B, Gorson, D, Puri, S, Arauz-Pacheco, C, Forman, S, Akyea-Djamson, A, Lieber, I, Barker, B, Desai, P, Sotolongo, C, Steinhoff, J, Hill, R, Radin, M, Patel, R, Lieberman, S, Wenocur, H, Dagogo-Jack, S, Lupovitch, S, Ison, R, Bacharach, J, Diogo, J, Mazzella, M, Greenwald, J, Quadrel, M, Mayer, N, Datu, J, Mccartney, M, Bruce, T, Singal, D, Turner, J, Videau, B, Fritz, R, Fox, D, Calatayud, G, Sheldon, W, Kereiakes, D, Thomas, J, Salacata, A, Mccullum, K, Harris, B, de Souza, J, Rahman, A, Blumenthal, S, Narayan, P, Bloch, M, Augenbraun, C, Bernstein, R, Perlman, R, Berman, J, Labryer, L, Wynne, A, Fish, J, Zarich, S, Gabra, N, Popeil, L, Hermany, P, Barreto, A, Pomposini, D, Gonzalez-Campoy, J, Langer, M, Bayron, C, Suneja, R, Kamlet, J, Wheeler, K, Hurley, S, Sharma, S, Wefald, F, Hershon, K, O'Connor, T, Pueblitz, G, Laguerre, J, Amin, M, Alfonso, T, Jaffrani, N, Isserman, S, Portnay, E, Vlastaris, A, Dy, J, Hagan, M, Noveck, H, Kraft, P, Andersen, J, Foley, B, Carr, K, Gelormini, J, Williams, T, Landau, C, Richwine, R, Thakkar, M, Karim, A, Madhun, Z, Francyk, D, Lamantia, J, Baker, B, Zhang, W, Lev, V, Hasan, M, Captain, A, Herzog, W, Friedman, K, Lawson, W, Desai, V, Ow, C, Simons, R, Mandviwala, M, Le, T, Hack, T, Zebrack, J, Henderson, D, Dejulia, J, Mehta, R, Reza, S, Poonawala, R, Awad, A, Velasquez, M, Mohiuddin, S, Salazar Sharma, M, Myrick, G, Gottlieb, D, Ovalle, F, Alfieri, A, Ahmed, S, Bohula, E, Donahoe, S, Longshaw, K, Eshaghian, S, Lash, J, Goldberg, R, Fox, B, Mostel, E, Dobies, D, Ward, H, Burbano, J, Puleo, P, Lenhard, M, Korn, D, Thadani, U, Bradley, A, Kmetzo, J, Heasley, E, Raikhel, M, Mahr, N, Bittar, G, Fuentes, F, Raghu, P, Diep, T, Tran, Q, Tran, N, Nguyen, D, and Nguyen, V
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Male ,medicine.medical_specialty ,dapagliflozin, placebo ,[SDV]Life Sciences [q-bio] ,Renal function ,Type 2 diabetes ,[SDV.BC]Life Sciences [q-bio]/Cellular Biology ,030204 cardiovascular system & hematology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Glucosides ,Diabetes mellitus ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Benzhydryl Compounds ,Dapagliflozin ,Sodium-Glucose Transporter 2 Inhibitors ,ComputingMilieux_MISCELLANEOUS ,Aged ,Heart Failure ,Canagliflozin ,business.industry ,[SDV.BA]Life Sciences [q-bio]/Animal biology ,General Medicine ,Middle Aged ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,medicine.disease ,Hospitalization ,Diabetes Mellitus, Type 2 ,chemistry ,Cardiovascular Diseases ,Heart failure ,Cardiology ,Female ,business ,[SDV.AEN]Life Sciences [q-bio]/Food and Nutrition ,Mace ,medicine.drug - Abstract
BACKGROUND The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to ≥60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], ≥1.3; P≥0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P = 0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P = 0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87), and death from any cause occurred in 6.2% and 6.6%, respectively (hazard ratio, 0.93; 95% CI, 0.82 to 1.04). Diabetic ketoacidosis was more common with dapagliflozin than with placebo (0.3%vs. 0.1%, P = 0.02), as was the rate of genital infections that led to discontinuation of the regimen or that were considered to be serious adverse events (0.9% vs. 0.1%, P≥0.001). CONCLUSIONS In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin did not result in a higher or lower rate of MACE than placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure, a finding that reflects a lower rate of hospitalization for heart failure. (Funded by AstraZeneca; DECLARETIMI 58 ClinicalTrials.gov number, NCT01730534
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- 2019
5. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial
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Hernandez, A, Green, J, Janmohamed, S, D'Agostino, R, Granger, C, Jones, N, Leiter, L, Rosenberg, A, Sigmon, K, Somerville, M, Thorpe, K, Mcmurray, J, Del Prato, S, Califf, R, Holman, R, Demets, D, Riddle, M, Goodman, S, Mcguire, D, Alexander, K, Devore, A, Melloni, C, Patel, C, Kong, D, Bloomfield, G, Roe, M, Tricoci, P, Harrison, R, Lopes, R, Mathews, R, Mehta, R, Schuyler Jones, W, Vemulapalli, S, Povsic, T, Eapen, Z, Dombrowski, K, Kolls, B, Jordan, D, Ambrosy, A, Greene, S, Mandawat, A, Shavadia, J, Cooper, L, Sharma, A, Guimaraes, P, Friedman, D, Wilson, M, Endsley, P, Gentry, T, Collier, J, Perez, K, James, K, Roush, J, Pope, C, Howell, C, Johnson, M, Bailey, M, Cole, J, Akers, T, Vandyne, B, Thomas, B, Rich, J, Bartone, S, Beaulieu, G, Brown, K, Chau, T, Christian, T, Coker, R, Greene, D, Haddock, T, Jenkins, W, Haque, G, Marquess, M, Pesarchick, J, Rethaford, R, Stone, A, Al Kawas, F, Anderson, M, Enns, R, Sinay, I, Mathieu, C, Yordanov, V, Hramiak, I, Haluzik, M, Galatius, S, Guerci, B, Nauck, M, Migdalis, I, Tan, C, Kocsis, G, Giaccari, A, Lee, M, Munoz, E, Cornel, J, Birkeland, K, Pinto, M, Tirador, L, Olesinska-Mader, M, Shestakova, M, Distiller, L, Lopez-Sendon, J, Eliasson, B, Chiang, C, Srimahachota, S, Mankovsky, B, Bethel, M, Dungan, K, Kosiborod, M, Alvarisqueta, A, Baldovino, J, Besada, D, Calella, P, Cantero, M, Castano, P, Chertkoff, A, Cuadrado, J, De Loredo, L, Dominguez, A, Espanol, M, Finkelstein, H, Frechtel, G, Fretes, J, Garrido Santos, N, Gonzalez, J, Litvak, M, Loureyro, J, Maffei, L, Maldonado, N, Mohr Gasparini, D, Orio, S, Perez Manghi, F, Rodriguez Papini, N, Sala, J, Schygiel, P, Sposetti, G, Ulla, M, Verra, F, Zabalua, S, Zaidman, C, Crenier, L, Debroye, C, Duyck, F, Scheen, A, Van Gaal, L, Vercammen, C, Damyanova, V, Dimitrov, S, Kovacheva, S, Lozanov, L, Margaritov, V, Mihaylova-Shumkova, R, Nikolaeva, A, Stoyanova, Z, Akhras, R, Beaudry, Y, Bedard, J, Berlingieri, J, Chehayeb, R, Cheung, S, Conway, J, Cusson, J, Della Siega, A, 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Kosch, C, Lorra, B, Luedemann, J, Luttermann, M, Maxeiner, S, Milek, K, Moelle, A, Neumann, G, Nischik, R, Oehrig-Pohl, E, Plassmann, G, Pohlmeier, L, Proepper, F, Regner, S, Rieker, W, Rose, L, Samer, H, Sauter, J, Schaper, F, Schiffer, C, Schmidt, J, Scholz, B, Schulze, J, Segner, A, Seufert, J, Sigal, H, Steindorf, J, Stockhausen, J, Stuebler, P, Taeschner, H, Tews, D, Tschoepe, D, Wilhelm, K, Zeller-Stefan, H, Avramidis, I, Bousboulas, S, Bristianou, M, Dimitriadis, G, Elisaf, M, Kotsa, K, Melidonis, A, Mitrakou, A, Pagkalos, E, Papanas, N, Pappas, A, Sampanis, C, Tentolouris, N, Tsapas, A, Tzatzagou, G, Ozaki, R, Hajdu, C, Harcsa, E, Konyves, L, Mucsi, J, Pauker, Z, Petro, G, Ples, Z, Revesz, K, Sandor, V, Vass, V, Avogaro, A, Boemi, M, Bonadonna, R, Consoli, A, De Cosmo, S, Di Bartolo, P, Dotta, F, Frontoni, S, Galetta, M, Gambineri, A, Gazzaruso, C, Giorgino, F, Lauro, D, Orsi, E, Paolisso, G, Perriello, G, Piatti, P, Pontiroli, A, Ponzani, P, Rivellese, A, Sesti, G, Tonolo, G, 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Dreval, A, Ershova, O, Galstyan, G, Garganeeva, A, Izmozherova, N, Karetnikova, V, Kharakhulakh, M, Khokhlov, A, Kobalava, Z, Koshelskaya, O, Kosmacheva, E, Kostin, V, Koziolova, N, Kuzin, A, Lesnov, V, Lysenko, T, Markov, V, Mayorov, A, Moiseev, S, Myasoedova, S, Petunina, N, Rebrov, A, Ruyatkina, L, Samoylova, J, Sazonova, O, Shilkina, N, Sokolova, N, Vasilevskaya, O, Verbovaya, N, Vishneva, E, Vorobyev, S, Vorokhobina, N, Zanozina, O, Zhdanova, E, Zykova, T, Burgess, L, Coetzee, K, Dawood, S, Lombard, L, Makotoko, E, Moodley, R, Oosthuysen, W, Sarvan, M, Calvo Gomez, C, Cano Rodriguez, I, Castro Conde, A, Cequier Fillat, A, Cuatrecasas Cambra, G, de Alvaro Moreno, F, De Teresa Parreno, L, Delgado Lista, J, Dominguez Escribano, J, Duran Garcia, S, Elvira Gonzalez, J, Fernandez Rodriguez, J, Goday Arno, A, Gomez Huelgas, R, Gonzalez Juanatey, J, Hernandez Mijares, A, Jimenez Diaz, V, Jodar Gimeno, E, Lucas Morante, T, Marazuela, M, Martell Claros, N, Mauricio Puente, D, Mena Ribas, E, 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J, Daga, S, Sowell, M, Patel, P, Garvey, L, Ackert, J, Abraham, S, Sabol, M, Altobelli, D, Ha, J, Kulkarni, M, Noronha, D, Casson, E, Zang, E, Sandhu, C, Kumar, R, Chen, D, Taft, L, Ye, J, Shannon, J, Wilson, T, Babi, C, Miller, D, Russell, R, Bull, G, Hereghty, B, Fernandez-Salazar, E, Longley, T, Donaldson, J, Jarosz, M, Murphy, K, Adams, P, James, R, Richards, J, Sedani, S, Althouse, D, Watson, D, Lorimer, J, Lauder, S, Schultheis, R, Womer, T, Wraight, E, Li, W, Price-Olsen, E, Watson, A, Kelly, A, Mclaughlin, P, Fleming, J, Schubert, J, Schleiden, D, Harris, T, Prakash, R, Breneman, J, Deshpande, S, Saswadkar, A, Kumari, A, Shitut, A, Raorane, A, Karmalkar, A, Mhambrey, A, Bhosale, A, Vaphare, A, Patil, A, Khandelwal, C, Shaik, F, Nadar, M, Karka, M, Kadgaonkar, N, Gupta, N, Aher, N, Potnis, O, Naicker, P, Shinde, R, Sharma, R, Godse, R, Solanki, S, Sahu, S, Dumbre, S, Kumar, S, Patil, S, Mandal, T, Hernandez A. F., Green J. B., Janmohamed S., D'Agostino R. B., Granger C. B., Jones N. P., Leiter L. A., Rosenberg A. E., Sigmon K. N., Somerville M. C., Thorpe K. M., McMurray J. J. V., Del Prato S., Califf R. M., Holman R., DeMets D., Riddle M., Goodman S., McGuire D., Alexander K., Devore A., Melloni C., Patel C., Kong D., Bloomfield G., Roe M., Tricoci P., Harrison R., Lopes R., Mathews R., Mehta R., Schuyler Jones W., Vemulapalli S., Povsic T., Eapen Z., Dombrowski K., Kolls B., Jordan D., Ambrosy A., Greene S., Mandawat A., Shavadia J., Cooper L., Sharma A., Guimaraes P., Friedman D., Wilson M., Endsley P., Gentry T., Collier J., Perez K., James K., Roush J., Pope C., Howell C., Johnson M., Bailey M., Cole J., Akers T., Vandyne B., Thomas B., Rich J., Bartone S., Beaulieu G., Brown K., Chau T., Christian T., Coker R., Greene D., Haddock T., Jenkins W., Haque G., Marquess M., Pesarchick J., Rethaford R., Stone A., Al Kawas F., Anderson M., Enns R., Sinay I., Mathieu C., Yordanov V., Hramiak I., Haluzik M., Galatius S., Guerci B., Nauck M., Migdalis I., Tan C. B. K., Kocsis G., Giaccari A., Lee M. K., Munoz E. G. C., Cornel J., Birkeland K., Pinto M., Tirador L., Olesinska-Mader M., Shestakova M., Distiller L., Lopez-Sendon J., Eliasson B., Chiang C. -E., Srimahachota S., Mankovsky B., Bethel M. A., Dungan K., Kosiborod M., Alvarisqueta A., Baldovino J., Besada D., Calella P., Cantero M. C., Castano P., Chertkoff A., Cuadrado J., De Loredo L., Dominguez A., Espanol M. V., Finkelstein H., Frechtel G., Fretes J., Garrido Santos N., Gonzalez J., Litvak M., Loureyro J., Maffei L., Maldonado N., Mohr Gasparini D., Orio S., Perez Manghi F., Rodriguez Papini N., Sala J., Schygiel P., Sposetti G., Ulla M., Verra F., Zabalua S., Zaidman C., Crenier L., Debroye C., Duyck F., Scheen A., Van Gaal L., Vercammen C., Damyanova V., Dimitrov S., Kovacheva S., Lozanov L., Margaritov V., Mihaylova-Shumkova R., Nikolaeva A., Stoyanova Z., Akhras R., Beaudry Y., Bedard J., Berlingieri J., Chehayeb R., Cheung S., Conway J., Cusson J., Della Siega A., Dumas R., Dzongowski P., Ferguson M., Gaudet D., Grondin F., Gupta A., Gupta M., Halperin F., Houle P. -A., Jones M., Kouz S., Kovacs C., Landry D., Lonn E., O'Mahony W., Peterson S., Reich D., Rosenbloom A., St-Maurice F., Tugwell B., Vizel S., Woo V., Brychta T., Cech V., Dvorakova E., Edelsberger T., Halciakova K., Krizova J., Lastuvka J., Piperek M., Prymkova V., Raclavska L., Silhova E., Urbanek R., Vrkoc J., Andersen U., Bronnum-Schou J., Hove J., Jensen J. 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P., Lund P., Melchior T., Nyvad O., Schou M., Boye A., Cadinot D., Gouet D., Henry P., Kessler L., Lalau J. -D., Petit C., Thuan J. -F., Voinot C., Vouillarmet J., Axthelm C., Berger D., Bieler T., Birkenfeld A., Bott J., Busch K., Caca K., Chevts J., Donaubauer T., Erlinger R., Funke K., Grosskopf J., Hagenow A., Hamann M., Hartard M., Heymer P., Huppertz W., Illies G., Jacob S., Jung T., Kahrmann G., Kast P., Kellerer M., Kempe H. -P., Khariouzov A., Klausmann G., Klein C., Kleinecke-Pohl U., Kleinertz K., Koch T., Kosch C., Lorra B., Luedemann J., Luttermann M., Maxeiner S., Milek K., Moelle A., Neumann G., Nischik R., Oehrig-Pohl E., Plassmann G., Pohlmeier L., Proepper F., Regner S., Rieker W., Rose L., Samer H., Sauter J., Schaper F., Schiffer C., Schmidt J., Scholz B. -M., Schulze J., Segner A., Seufert J., Sigal H., Steindorf J., Stockhausen J., Stuebler P., Taeschner H., Tews D., Tschoepe D., Wilhelm K., Zeller-Stefan H., Avramidis I., Bousboulas S., Bristianou M., Dimitriadis G., Elisaf M., Kotsa K., Melidonis A., Mitrakou A., Pagkalos E., Papanas N., Pappas A., Sampanis C., Tentolouris N., Tsapas A., Tzatzagou G., Ozaki R., Hajdu C., Harcsa E., Konyves L., Mucsi J., Pauker Z., Petro G., Ples Z., Revesz K., Sandor V., Vass V., Avogaro A., Boemi M., Bonadonna R., Consoli A., De Cosmo S., Di Bartolo P., Dotta F., Frontoni S., Galetta M., Gambineri A., Gazzaruso C., Giorgino F., Lauro D., Orsi E., Paolisso G., Perriello G., Piatti P., Pontiroli A., Ponzani P., Rivellese A. 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R., Duran Garcia S., Elvira Gonzalez J., Fernandez Rodriguez J. M., Goday Arno A., Gomez Huelgas R., Gonzalez Juanatey J. R., Hernandez Mijares A., Jimenez Diaz V. A., Jodar Gimeno E., Lucas Morante T., Marazuela M., Martell Claros N., Mauricio Puente D., Mena Ribas E., Merino Torres J. F., Mezquita Raya P., Nubiola Calonge A., Ordonez Sanchez X., Pascual Izuel J. M., Perea Castilla V., Perez Perez A., Perez Soto I., Quesada Charneco M., Quesada Simon A., Redon Mas J., Rego Iraeta A., Rodriguez Alvarez M., Rodriguez Rodriguez I., Saban Ruiz J., Soto Gonzalez A., Tinahones Madueno F., Trescoli Serrano C., Ulied Arminana A., Bachus E., Berndtsson Blom K., Eliasson K., Koskinen P., Larnefeldt H., Lif-Tiberg C., Linderfalk C., Lund G., Lundman P., Moris L., Olsson A., Salmonsson S., Sanmartin Berglund J., Sjoberg F., Soderberg S., Torstensson I., Chen J. -F., Tien K. 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M., Dauber I., Davila W., De Armas L., Dean J., Detweiler R., Diaz E., Di Giovanna M., Dor I., Drummond W., Eagerton D., Earl J., Eaton C., Ellison H., Farris N., Fiel T., Firek A., First B., Forgosh L., French W., Gandy W., Garcia R., Gill S., Gordon M., Guice M., Gummadi S., Hackenyos J., Hairston K., Hanson L., Harrison L., Hartman I., Heitner J., Hejeebu S., Hermany P., Hernandez-Cassis C., Hidalgo H., Higgins A., Ibrahim H., Jacobs S., Johnson D., Joshi P., Kaster S., Kellum D., Kim C., Kim E., Kirby W., Knouse A., Kulback S., Kumar M., Kuruvanka T., Labroo A., Lasswell W., Lentz J., Lenzmeier T., Lewis D., Li Z., Lillestol M., Little R., Lorraine R., McKeown-Biagas C., McNeill R., Mehta A., Miller A., Moran J., Morawski E., Nadar V., O'Connor T., Odio A., Parker R., Patel R., Phillips L., Raad G., Rahman A., Raikhel M., Raisinghani A., Rajan R., Rasouli N., Rauzi F., Rohr K., Roseman H., Rovner S., Saba F., Sachson R., Schabauer A., Schneider R., Schuchard T., Sensenbrenner J., Shlesinger Y., Singh N., Sivalingam K., Stonesifer L., Storey D., Suh D., Tahir M., Tan A., Tan M., Taylon A., Thakkar M., Tripathy D., Uwaifo G., Vedere A., Venugopal C., Vo A., Welch M., Welker J., White A., Willis J., Wynne A., Yazdani S., Price L., Lokhngina Y., Xing W., Overton R., Stewart M., Stead J., Lindsay A., Patel V., Ross J., Soffer J., Daga S., Sowell M., Patel P., Garvey L., Ackert J., Abraham S., Sabol M. B., Altobelli D., Ha J., Kulkarni M., Noronha D., Casson E., Zang E., Sandhu C., Kumar R., Chen D., Taft L., Ye J., Shannon J., Wilson T., Babi C., Miller D., Russell R., Bull G., Hereghty B., Fernandez-Salazar E., Longley T., Donaldson J., Jarosz M., Murphy K., Adams P., James R., Richards J., Sedani S., Althouse D., Watson D., Lorimer J., Lauder S., Schultheis R., Womer T., Wraight E., Li W., Price-Olsen E., Watson A., Kelly A., McLaughlin P., Fleming J., Schubert J., Schleiden D., Harris T., Prakash R., Breneman J., Deshpande S., Saswadkar A., Kumari A., Shitut A., Raorane A., Karmalkar A., Mhambrey A., Bhosale A., Vaphare A., Patil A. P., Khandelwal C., Shaik F., Nadar M., Karka M., Kadgaonkar N., Gupta N., Aher N., Potnis O., Naicker P., Shinde R., Sharma R., Godse R., Solanki S., Sahu S., Dumbre S., Kumar S., Patil S., Mandal T., Hernandez, A, Green, J, Janmohamed, S, D'Agostino, R, Granger, C, Jones, N, Leiter, L, Rosenberg, A, Sigmon, K, Somerville, M, Thorpe, K, Mcmurray, J, Del Prato, S, Califf, R, Holman, R, Demets, D, Riddle, M, Goodman, S, Mcguire, D, Alexander, K, Devore, A, Melloni, C, Patel, C, Kong, D, Bloomfield, G, Roe, M, Tricoci, P, Harrison, R, Lopes, R, Mathews, R, Mehta, R, Schuyler Jones, W, Vemulapalli, S, Povsic, T, Eapen, Z, Dombrowski, K, Kolls, B, Jordan, D, Ambrosy, A, Greene, S, Mandawat, A, Shavadia, J, Cooper, L, Sharma, A, Guimaraes, P, Friedman, D, Wilson, M, Endsley, P, Gentry, T, Collier, J, Perez, K, James, K, Roush, J, Pope, C, Howell, C, Johnson, M, Bailey, M, Cole, J, Akers, T, Vandyne, B, Thomas, B, Rich, J, Bartone, S, Beaulieu, G, Brown, K, Chau, T, Christian, T, Coker, R, 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- Abstract
Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were
- Published
- 2018
6. Quality of life versus glycaemic variability and time in range in people with type 1 diabetes : sub study of the RESCUE-trial
- Author
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Pieter Gillard, El Malahi, A., Elsen, M., Charleer, S., Ridder, F., Ledeganck, K., Keymeulen, B., Crenier, L., Radermecker, R., Lapauw, B., Vercammen, C., Nobels, F., Mathieu, C., and Block, C.
- Subjects
Medicine and Health Sciences - Published
- 2020
7. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial
- Author
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LaRocque, J.C., Gross, J.L., Wallenstein, S.O.R., Bilz, S., Oğuz, A., Christiansen, E., El Hefnawy, M.H.M.F., Özdemir, A., Finneran, M.P., Rista, L., Akın, S., O'Connor, T.M., Gulseth, H.L., Kim, N.H., Lederman, S.N., Mertens, A., Arif, A.A., Nicol, P.R., Ong, S., Aronne, L.J., Sorli, C.H., Winnie, M., Fließer-Görzer, E., Tetiker, T., Pieber, T., Condit, J., Eagerton, D.C., Murray, A.V., Weiss, D., Aladağ, N., Litchfield, W.R., Cooper, J., Riffer, E., Colin, I., Prager, R., Beckett, P.L., Baik, S.H., Scheen, A., Godbole, N.A., Bays, H., Cho, Y.M., White, A., Fischli, S., Kang, E.S., Lee, K.-W., Weinstein, D.L., Shelbaya, S.A., Chung, C.H., Rudofsky, G., Laimer, M., Sivalingam, K., Wium, C., Pereles-Ortiz, J., PIONEER 7 investigators, Seo, J.A., Buse, J.B., Warren, M.L., Palchick, B.A., Delgado, B., Ataoglu, E., Khalil, S.H.A., Streja, D.A., Eliaschewitz, F.G., Golay, A., Høivik, H.O., Helland, F., Gorban de Lapertosa, S., Sarı, R., T'Sjoen, G., Van Gaal, L., Vercammen, C., Pieber, T.R., Hertz, C.L., Morawski, E.J., Kim, I.J., Stäuble, S., Issa, C., Geohas, J., Canani, L.H.S., Klaff, L.J., Manning, M.B., Bode, B., Yavuz, D., Preumont, V., Schultes, B., Aronoff, S., Palace, E.M., El Ebrashy, I.N., Keller, C., Berker, D., and Braun, E.W.
- Abstract
Background: Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg. Methods: In this 52-week, multicentre, randomised, open-label, phase 3a trial, we recruited patients with type 2 diabetes from 81 sites in ten countries. Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA1c of 7·5–9·5% (58–80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening). Participants were randomly assigned (1:1) by use of an interactive web-response system, stratified by background glucose-lowering medication at screening, to oral semaglutide with flexible dose adjustments to 3, 7, or 14 mg once daily or sitagliptin 100 mg once daily. To approximate treatment individualisation in clinical practice, oral semaglutide dose could be adjusted on the basis of prespecified HbA1c and tolerability criteria. Two efficacy-related estimands were prespecified: treatment policy (regardless of treatment discontinuation or use of rescue medication) and trial product (on treatment and without use of rescue medication) for participants randomly assigned to treatment. The primary endpoint was achievement of HbA1c of less than 7% (53 mmol/mol) at week 52 and the confirmatory secondary efficacy endpoint was change in bodyweight from baseline to week 52. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02849080, and European Clinical Trials Database, EudraCT number 2015-005593-38, and an open-label extension is ongoing. Findings: Between Sept 20, 2016, and Feb 7, 2017, of 804 patients assessed for eligibility, 504 were eligible and randomly assigned to oral semaglutide (n=253) or sitagliptin (n=251). Most participants were male (285 [57%] of 504) with a mean age of 57·4 years (SD 9·9). All participants were given at least one dose of their allocated study drug except for one participant in the sitagliptin group. From a mean baseline HbA1c of 8·3% (SD 0·6%; 67 mmol/mol [SD 6·4]), a greater proportion of participants achieved an HbA1c of less than 7% with oral semaglutide than did with sitagliptin (treatment policy estimand: 58% [134 of 230] vs 25% [60 of 238]; and trial product estimand: 63% [123 of 196] vs 28% [52 of 184]). The odds of achieving an HbA1c of less than 7% was significantly better with oral semaglutide than sitagliptin (treatment policy estimand: odds ratio [OR] 4·40, 95% CI 2·89–6·70, p
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- 2019
- Full Text
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8. Empagliflozin and Kidney Function Decline in Patients with Type 2 Diabetes: A Slope Analysis from the EMPA-REG OUTCOME Trial
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Wanner, Christoph, Heerspink, Hiddo J. L., Zinman, Bernard, Inzucchi, Silvio E., Koitka-Weber, Audrey, Mattheus, Michaela, Hantel, Stefan, Woerle, Hans-Juergen, Broedl, Uli C., von Eynatten, Maximilian, Groop, Per-Henrik, Aizenberg, D., Ulla, M., Waitman, J., De Loredo, L., Farias, J., Fideleff, H., Lagrutta, M., Maldonado, N., Colombo, H., Ferre Pacora, F., Wasserman, A., Maffei, L., Lehman, R., Selvanayagam, J., d'Emden, M., Fasching, P., Paulweber, B., Toplak, H., Luger, A., Drexel, H., Prager, R., Schnack, C., Schernthaner, G., Fliesser-Goerzer, E., Kaser, S., Scheen, A., Van Gaal, Luc, Hollanders, G., Kockaerts, Y., Capiau, L., Chachati, A., Persu, A., Hermans, M., Vantroyen, D., Vercammen, C., Van de Borne, P., Mathieu, C., Benhalima, Katrien, Lienart, F., Mortelmans, J., Strivay, M., Vereecken, G., Keymeulen, B., Lamkanfi, F., Chacra, A., Eliaschewitz, F., Zanella, M., Faludi, A., Bertolami, M., Hayashida, C., Nunes Salles, J., Monte, O., Dinato, M., Manenti, E., Rassi, N., Halpern, A., Lima Filho, M., Ayoub, J., Felicio, J., Borges, J., Gross, J., Sgarbi, J., Betti, R., Tiburcio, A., Purisch, S., Schmid, H., Takahashi, M., Castro, M., Rea, R., Hissa, M., Geloneze Neto, B., Saraiva, J., Henein, S., Lochnan, H., Imran, S. A., Clayton, D., Bayly, K., Berlingieri, J., Boucher, P., Chan, Y., Gupta, M., Chehayeb, R., Ouellett, A., Ur, E., Woo, V., Zinman, B., St Amour, E., Terront Lozano, M., Yupanqui Lozno, H., Urina, M., Lopez Jaramillo, P., Jaramillo, N., Sanchez, G., Perez, G., Tusek, S., Mirosevic, G., Goldoni, V., Jurisic-Erzen, D., Balasko, A., Balic, S., Drvodelic-Sunic, E., Varzic, S. Canecki, Machkova, M., Weiner, P., Lastuvka, J., Olsovsky, J., Krarup, T., Ridderstrale, M., Tarnow, L., Boesgaard, T. Wellov, Lihn, A. Saetre, Christensen, P., Juhl, H., Urhammer, S., Lund, P., Adojaan, B., Jakovlev, U., Lanno, R., Lubi, M., Marandi, T., Gouet, D., Courreges, J., Zaoui, P., Choukroun, G., Petit, C., Formagne, L., Estour, B., Mabire, P., Daugenet, C., Lemarie, B., Clavel, S., Aure, P., Remaud, P., Halimi, J., Hadjadj, S., Couffinhal, T., Glonti, S., Metreveli, D., Lominadze, Z., Giorgadze, E., Burtchuladze, T., Javashvili, L., Kurashvili, G., Kurashvili, R., Virsaladze, D., Nadareishvili, L., Khomasuridze, A., Cahill, T., Green, F., MacRury, S., Waldron, M., Middleton, A., McKnight, J., Pearson, E., Butler, M., Choksi, M., Caldwell, I., Farmer, I., Wyatt, N., Patrick, J., O'Brien, I., Devers, M., Bousboulas, S., Pappas, S., Piaditis, G., Vryonidou, A., Tentolouris, N., Karamitsos, K., Manes, C., Benroubi, M., Avramidis, I., Ozaki, R., Tan, K., Siu, S., Tsang, C., Dudas, M., Nagy, K., Salamon, C., Ip, T., Geroo, L., Patkay, J., Tabak, A., Juhasz, F., Szentpeteri, I., Tamas, G., Ghaisas, N., Bantwal, G., Mohan, V., Gupta, J., Sadhu, N., Kulkarni, A., Garg, N., Reddy, S., Deshpande, N., Gutlapalli, K., Pillai, M., Premchand, R., Badgandi, M., Jain, S., Aravind, S., Shamanna, P., Pandey, A., Gupta, S., Pramono, B., Saksono, H. Dante, Agung, P., Wahono, S. Djoko, Suastika, K., Tanggo, Y., Juwana, Y., Siswanto, B., Adawi, F., Efrati, S., Mazen, E., Bashkin, A., Herskovits, T., Jaffe, A., Schiff, E., Wainstein, J., Taddei, S., Aiello, A., Arca, M., Calabro, P., Cignarelli, M., Fioretto, P., Reggiani, G. Marchesini, Gnasso, A., Marchionni, N., Marsilii, A., Bucci, M., Mezzetti, A., Pozzilli, P., Colivicchi, F., Santini, M., Moro, E., Toscano, V., Fucili, A., Semplicini, A., Monno, S., Furui, K., Higashiue, S., Hiramatsu, N., Kawamitsu, K., Takenaka, T., Takahashi, H., Hojo, F., Onishi, Y., Izumino, K., Okubo, M., Wakida, Y., Kondo, Y., Hieshima, K., Jinnouchi, H., Suzuki, A., Ito, M., Park, S., Kim, Y., Hong, T., Park, H., Gwon, H., Kim, H., Kang, K., Jeong, M., Seung, K., Lim, D., Rha, S., Tahk, S., Yang, J., Yoon, J., Shin, M., Kim, D., Jeong, J., Ahmad, N. Nik, Mustafa, N., Mohamed, W. Wan, Fung, Y., Ghani, R. Abdul, Chandramouli, A., Chee, K., Kadir, K. Abdul, Ling, K., Abu Hassan, M., Foo, S., Lee, S., Garcia Hernandez, P., Aguilar-Salinas, C., Vidrio Velazquez, M., Flores, F., Alpizar Salazar, M., Micher Escalante, D., Garcia Soria, M., Cardona Munoz, E., Storms, G., Schaper, N., Kooy, A., Krekels, M., van Bemmel, T., Verhoeven, R., Mulder, H., Oldenburg-Ligtenberg, P., Gonkel, F., de Jong, A., van Soest, J., Viergever, P., Mevissen, H., Lochorn, G., Zwiers, G., Hoogslag, P., Ronner, E., Nierop, P., Al-Windy, N., Kragten, J., Dekelver, P., Benatar, J., Krebs, J., Scott, R., Heggen, E., Berz, A., Fossum, C., Hurtig, U., Langslet, G., Baranowski, M., Sparby, J., Karlsson, T., Karlsson, Thomas, Delgado Torres, C., Rodriguez Escudero, A., Lisson, R., Allemant Maldonado, A., Gallardo Rojas, W., Gonzales Bravo, L., Lema Osores, J., Farfan, J., Zapata, L., Godoy Junchaya, J., Roldan Concha, Y., Urquiaga Calderon, J., Sy, R., Tan, G., Aquitania, G., De Los Santos, G., Panelo, A., Roderos, O., Rosales, R., Toledo, R., Liwag, A., Ramoncito, H., Skokowska, E., Krzyzagorska, E., Ogorek, M., Wojnowski, L., Spyra, J., Konieczny, M., Piesiewicz, W., Kus, W., Ocicka-Kozakiewicz, A., Orlowska-Kunikowska, E., Zmuda, W., Duarte, S., Leitao, A., Monteiro, P., Rita, H., Salgado, V., Pinto, L., Queiros, J., Teixeira, J., Rogado, C., Duarte, R., Sobral do Rosario, F., Silva, A., Andrade, L., Velez, M., Brazao, M., Istratoaie, O., Lichiardopol, R., Catrinoiu, D., Militaru, C., Zetu, C., Barbonta, D., Cosma, D., Crisan, C., Pop, L., Esip, V., Khetagurova, F., Petrov, A., Arutyunov, G., Boyarkin, M., Agafyina, A., Vorokhobina, N., Petunina, N., Libov, I., Zalevskaya, A., Nikolaev, K., Barbarash, O., Potemkin, V., Bystrova, A., Krasilnikova, E., Barbarich, V., Chumakova, G., Tarasov, N., Meleshkevich, T., Zateyshchikov, D., Lantseva, O., Belenkiy, D., Obrezan, A., Rossolko, L., Fillipova, E., Yakhontova, P., Khokhlov, A., Tan, R., Sum, C., Chang, H., Distiller, L., Pretorius, M., Nortje, H., Mitha, E., Burgess, L., Blignaut, S., Venter, T., Moodley, R., Lombaard, J., Govind, U., Naidoo, V., Mookadam, M., Engelbrecht, J., Omar, M., Jurgens, J., Podgorski, G., Vawda, H., Naidoo, D., Emanuel, S., Roodt, A., Amod, A., Van Zyl, L., Segura, J., Brito, M., Fernandez-Cruz, A., Artola, S., Iglesias, R., Toural, E., Garcia-Ortiz, L., Saban, J., Mesa, J., Vidal, J., Linares, J., del Canizo, F., Rigla, M., Suarez, C., Llorente, I., Moreno, B., Antoli, A., Gomez Peralta, F., Iglesias, M., Pereg, V., de Teresa, L., Camafort, M., Trescoli, C., Satarasinghe, R., Somasundaram, N., Siyambalapitiya, S., Antonypillai, C., Bulugahapitiya, D., Medagama, U., Huang, C., Lu, Y., Hwang, J., Chiang, C., Wen, M., Chen, J., Lai, W., Chang, K., Wang, J., Yeh, H., Kriangsak, P., Deerochanawong, C., Suwanwalaikorn, S., Mangklabruks, A., Kaewsuwanna, P., Piyayotai, D., Iabluchanskyi, M., Samoylov, O., Godlevska, O., Kovalyova, O., Voloshyna, O., Tseluyko, V., Zotov, S., Vykhovanyuk, I., Dulgeroff, A., Mayfield, R., Zaniewski-Singh, M., Ullal, J., Aloi, J., De La Rosa, R., Mosely, J., Wittmer, B., Aronoff, S., Rosenfeld, J., Seidner, M., Warren, M., Fishman, N., Weiss, R., Arif, A., Sandberg, M., Lewis, D., Ball, E., Graf, R., Breton, C., Tamayo, R., Richards, R., Cefalu, W., Uwaifo, G., Zayour, D., Hoffman, J., Fitz-Patrick, D., Khan, B., Blaze, K., Bressler, P., Halpern, S., Chappell, D., Bergenstal, R., Cuddihy, R., Matfin, G., Freedman, Z., Gonzalez-Campoy, J., Lerman, S., Rendell, M., Sitar, S., Reeves, M., Howard, T., Soufer, J., Miranda-Palma, B., Laliotis, A., Shomali, M., Teltser, M., Hurley, D., Morawski, E., Cherlin, R., Houchin, V., Welch, M., Goytia-Leos, D., Syed, M., Kowaloff, E., Weinrauch, L., Peniston, J., Brockmyre, A., First, B., Feld, L., Huffman, D., Nassim, O., Gottschlich, G., Patel, A., Knopke, C., Hernandez, M., Diaz, J., Giugliano, G., Nicasio, J., Eagerton, D., Huntley, R., Reed, J., Magee, M., Hippert, R., Sofley, C., Alzohaili, O., Levins, P., Anspach, R., Shah, S., Brusco, O., Naidu, J., Lindenbaum, J., Jacks, R., Hammond, G., Arena, C., Saxman, K., Mach, M., Kerstein, H., Kereiakes, D., Wahlen, J., Wehmeier, K., Chaykin, L., Rothman, J., Fogelfeld, L., Stroger, John H., Bittar, N., Rosenstock, J., Kayne, D., Navarro, J., Colfer, H., Mokshagundam, S., Shandilya, L., Connery, L., Wysham, C., Dela Llana, A., Jardula, M., MacAdams, M., Flippo, G., Heurich, E., Curtis, C., Sanders, D., Rawls, R., Velazquez, F., Osea, E., Mahood, K., Feldman, G., Eder, F., Riley, E., Fowler, W., Jain, M., Shepard, M., Schear, M., Barker, B., Strout, C., Obiekwe, O., Shanik, M., Green, C., Blakney, E., Roberson, K., Bretton, E., Pish, R., Kaveh, K., Maynard, B., Barager, W., Soldyshev, R., Austin, B., Parmar, P., Simpson, R., Chauhan, A., Kasper, J., Burr, R., Patel, N., Mariano, H., Pluto, T., Bratcher, C., Juarez, M., Levinson, L., Awad, A., Longshaw, K., Hoffman, K., Richwine, R., Molter, D., Boscia, J., Kowalyk, S., Lemis, P., Liss, J., Orr, R., Riser, J., Wood, J., Ubani, A., Paine, W., Hassani, F., Miranda, F., Hansen, V., Hansen, Val R., Farris, N., Bowden, R., Ajani, D., Maw, K., Andersen, J., Bergman, B., Dunmyer, S., Brandon, D., Anderson, M., Bononi, P., Prawer, J., Seidman, B., Cruz, H., Wilks, K., DiSanto, L., Buynak, R., Christensen, T., Denker, P., Koppel, W., Stedman, M., Lewy-Alterbaum, L., Karim, S., Shapiro, J., Gardner, T., Oskin, T., Gabra, N., Malano, J., Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), and EMPA-REG OUTCOME Investigators
- Subjects
Male ,Placebo-controlled study ,PROGRESSION ,Type 2 diabetes ,030204 cardiovascular system & hematology ,PLACEBO-CONTROLLED TRIAL ,GLOMERULAR-FILTRATION-RATE ,HYPERFILTRATION ,law.invention ,ESTABLISHED CARDIOVASCULAR-DISEASE ,Cohort Studies ,MELLITUS ,0302 clinical medicine ,Randomized controlled trial ,Glucosides ,law ,Medicine ,Diabetic Nephropathies ,GFR DECLINE ,General Medicine ,Middle Aged ,Nephrology ,diabetes mellitus ,randomized controlled trials ,Disease Progression ,Female ,Glomerular Filtration Rate ,medicine.medical_specialty ,Urology ,Renal function ,030209 endocrinology & metabolism ,Placebo ,03 medical and health sciences ,Double-Blind Method ,Clinical Research ,Diabetes mellitus ,BASE-LINE CHARACTERISTICS ,END-POINTS ,Empagliflozin ,Humans ,Benzhydryl Compounds ,Sodium-Glucose Transporter 2 Inhibitors ,Aged ,COTRANSPORTER 2 INHIBITION ,Models, Statistical ,Dose-Response Relationship, Drug ,business.industry ,chronic kidney disease ,medicine.disease ,Confidence interval ,Diabetes Mellitus, Type 2 ,Human medicine ,business - Abstract
BACKGROUND: Empagliflozin slowed the progression of CKD in patients with type 2 diabetes and cardiovascular disease in the EMPA-REG OUTCOME Trial. In a prespecified statistical approach, we assessed treatment differences in kidney function by analyzing slopes of eGFR changes.METHODS: Participants (n=7020) were randomized (1:1:1) to empagliflozin 10 mg/d, empagliflozin 25 mg/d, or placebo added to standard of care. We calculated eGFR slopes using random-intercept/random-coefficient models for prespecified study periods: treatment initiation (baseline to week 4), chronic maintenance treatment (week 4 to last value on treatment), and post-treatment (last value on treatment to follow-up).RESULTS: Compared with placebo, empagliflozin was associated with uniform shifts in individual eGFR slopes across all periods. On treatment initiation, adjusted mean slope (eGFR change per week, ml/min per 1.73 m2) decreased with empagliflozin (-0.77; 95% confidence interval, -0.83 to -0.71; placebo: 0.01; 95% confidence interval, -0.08 to 0.10; PCONCLUSIONS: The hemodynamic effects of empagliflozin, associated with reduction in intraglomerular pressure, may contribute to long-term preservation of kidney function.
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- 2018
9. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial
- Author
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Pieber, Thomas R, primary, Bode, Bruce, additional, Mertens, Ann, additional, Cho, Young Min, additional, Christiansen, Erik, additional, Hertz, Christin L, additional, Wallenstein, Signe O R, additional, Buse, John B, additional, Akın, S, additional, Aladağ, N, additional, Arif, A A, additional, Aronne, L J, additional, Aronoff, S, additional, Ataoglu, E, additional, Baik, S H, additional, Bays, H, additional, Beckett, P L, additional, Berker, D, additional, Bilz, S, additional, Bode, B, additional, Braun, E W, additional, Buse, J B, additional, Canani, L H S, additional, Cho, Y M, additional, Chung, C H, additional, Colin, I, additional, Condit, J, additional, Cooper, J, additional, Delgado, B, additional, Eagerton, D C, additional, El Ebrashy, I N, additional, El Hefnawy, M H M F, additional, Eliaschewitz, F G, additional, Finneran, M P, additional, Fischli, S, additional, Fließer-Görzer, E, additional, Geohas, J, additional, Godbole, N A, additional, Golay, A, additional, Gorban de Lapertosa, S, additional, Gross, J L, additional, Gulseth, H L, additional, Helland, F, additional, Høivik, H O, additional, Issa, C, additional, Kang, E S, additional, Keller, C, additional, Khalil, S H A, additional, Kim, N H, additional, Kim, I J, additional, Klaff, L J, additional, Laimer, M, additional, LaRocque, J C, additional, Lederman, S N, additional, Lee, K-W, additional, Litchfield, W R, additional, Manning, M B, additional, Mertens, A, additional, Morawski, E J, additional, Murray, A V, additional, Nicol, P R, additional, O'Connor, T M, additional, Oğuz, A, additional, Ong, S, additional, Özdemir, A, additional, Palace, E M, additional, Palchick, B A, additional, Pereles-Ortiz, J, additional, Pieber, T, additional, Prager, R, additional, Preumont, V, additional, Riffer, E, additional, Rista, L, additional, Rudofsky, G, additional, Sarı, R, additional, Scheen, A, additional, Schultes, B, additional, Seo, J A, additional, Shelbaya, S A, additional, Sivalingam, K, additional, Sorli, C H, additional, Stäuble, S, additional, Streja, D A, additional, T'Sjoen, G, additional, Tetiker, T, additional, Van Gaal, L, additional, Vercammen, C, additional, Warren, M L, additional, Weinstein, D L, additional, Weiss, D, additional, White, A, additional, Winnie, M, additional, Wium, C, additional, and Yavuz, D, additional
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- 2019
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10. Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk
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Zinman, Bernard, Inzucchi, Silvio E., Lachin, John M., Wanner, Christoph, Fitchett, David, Kohler, Sven, Mattheus, Michaela, Biomath, Dipl, Woerle, Hans J., Broedl, Uli C., Johansen, Odd Erik, Albers, Gregory W., Diener, Hans Christoph, Aizenberg, D., Ulla, M., Waitman, J., De Loredo, L., Farias, J., Fideleff, H., Lagrutta, M., Maldonado, N., Colombo, H., Ferre Pacora, F., Wasserman, A., Maffei, L., Lehman, R., Selvanayagam, J., d'Emden, M., Fasching, P., Paulweber, B., Toplak, H., Luger, A., Drexel, H., Prager, R., Schnack, C., Schernthaner, G., Fliesser-Goerzer, E., Kaser, S., Scheen, A., Van Gaal, L., Hollanders, G., Kockaerts, Y., Capiau, L., Chachati, A., Persu, A., Hermans, M., Vantroyen, D., Vercammen, C., Van de Borne, P., Mathieu, C., Benhalima, K., Lienart, F., Mortelmans, J., Strivay, M., Vereecken, G., Keymeulen, B., Lamkanfi, F., Chacra, A., Eliaschewitz, F., Zanella, M., Faludi, A., Bertolami, M., Hayashida, C., Nunes Salles, J., Monte, O., Dinato, M., Manenti, E., Rassi, N., Halpern, A., Lima Filho, M., Ayoub, J., Felicio, J., Borges, J., Gross, J., Sgarbi, J., Betti, R., Tiburcio, A., Purisch, S., Schmid, H., Takahashi, M., Castro, M., Rea, R., Hissa, M., Geloneze Neto, B., Saraiva, J., Henein, S., Lochnan, H., Imran, S. A., Clayton, D., Bayly, K., Berlingieri, J., Boucher, P., Chan, Y., Gupta, M., Chehayeb, R., Ouellett, A., Ur, E., Woo, V., Zinman, B., St Amour, E., Terront Lozano, M., Yupanqui Lozno, H., Urina, M., Lopez Jaramillo, P., Jaramillo, N., Sanchez, G., Perez, G., Tusek, S., Mirosevic, G., Goldoni, V., Jurisic-Erzen, D., Balasko, A., Balic, S., Drvodelic-Sunic, E., Varzic, S. Canecki, Machkova, M., Weiner, P., Lastuvka, J., Olsovsky, J., Krarup, T., Ridderstrale, M., Tarnow, L., Boesgaard, T. Wellov, Lihn, A. Saetre, Christensen, P., Juhl, H., Urhammer, S., Lund, P., Adojaan, B., Jakovlev, U., Lanno, R., Lubi, M., Marandi, T., Gouet, D., Courreges, J., Zaoui, P., Choukroun, G., Petit, C., Formagne, L., Estour, B., Mabire, P., Daugenet, C., Lemarie, B., Clavel, S., Aure, P., Remaud, P., Halimi, J., Hadjadj, S., Couffinhal, T., Glonti, S., Metreveli, D., Lominadze, Z., Giorgadze, E., Burtchuladze, T., Javashvili, L., Kurashvili, G., Kurashvili, R., Virsaladze, D., Nadareishvili, L., Khomasuridze, A., Cahill, T., Green, F., MacRury, S., Waldron, M., Middleton, A., McKnight, J., Pearson, E., Butler, M., Choksi, M., Caldwell, I., Farmer, I., Wyatt, N., Patrick, J., O'Brien, I., Devers, M., Bousboulas, S., Pappas, S., Piaditis, G., Vryonidou, A., Tentolouris, N., Karamitsos, K., Manes, C., Benroubi, M., Avramidis, I., Ozaki, R., Tan, K., Siu, S., Tsang, C., Dudas, M., Nagy, K., Salamon, C., Ip, T., Geroo, L., Patkay, J., Tabak, A., Juhasz, F., Szentpeteri, I., Tamas, G., Ghaisas, N., Bantwal, G., Mohan, V., Gupta, J., Sadhu, N., Kulkarni, A., Garg, N., Reddy, S., Deshpande, N., Gutlapalli, K., Pillai, M., Premchand, R., Badgandi, M., Jain, S., Aravind, S., Shamanna, P., Pandey, A., Gupta, S., Pramono, B., Saksono, H. Dante, Agung, P., Wahono, S. Djoko, Suastika, K., Tanggo, Y., Juwana, Y., Siswanto, B., Adawi, F., Efrati, S., Mazen, E., Bashkin, A., Herskovits, T., Jaffe, A., Schiff, E., Wainstein, J., Taddei, S., Aiello, A., Arca, M., Calabro, P., Cignarelli, M., Fioretto, P., Reggiani, G. Marchesini, Gnasso, A., Marchionni, N., Marsilii, A., Bucci, M., Mezzetti, A., Pozzilli, P., Colivicchi, F., Santini, M., Moro, E., Toscano, V., Fucili, A., Semplicini, A., Monno, S., Furui, K., Higashiue, S., Hiramatsu, N., Kawamitsu, K., Takenaka, T., Takahashi, H., Hojo, F., Onishi, Y., Izumino, K., Okubo, M., Wakida, Y., Kondo, Y., Hieshima, K., Jinnouchi, H., Suzuki, A., Ito, M., Park, S., Kim, Y., Hong, T., Park, H., Gwon, H., Kim, H., Kang, K., Jeong, M., Seung, K., Lim, D., Rha, S., Tahk, S., Yang, J., Yoon, J., Shin, M., Kim, D., Jeong, J., Ahmad, N. Nik, Mustafa, N., Mohamed, W. Wan, Fung, Y., Ghani, R. Abdul, Chandramouli, A., Chee, K., Kadir, K. Abdul, Ling, K., Abu Hassan, M., Foo, S., Lee, S., Garcia Hernandez, P., Aguilar-Salinas, C., Vidrio Velazquez, M., Flores, F., Alpizar Salazar, M., Micher Escalante, D., Garcia Soria, M., Cardona Munoz, E., Storms, G., Schaper, N., Kooy, A., Krekels, M., van Bemmel, T., Verhoeven, R., Mulder, H., Oldenburg-Ligtenberg, P., Gonkel, F., de Jong, A., van Soest, J., Viergever, P., Mevissen, H., Lochorn, G., Zwiers, G., Hoogslag, P., Ronner, E., Nierop, P., Al-Windy, N., Kragten, J., Dekelver, P., Benatar, J., Krebs, J., Scott, R., Heggen, E., Berz, A., Fossum, C., Hurtig, U., Langslet, G., Baranowski, M., Sparby, J., Karlsson, T., Karlsson, Thomas, Delgado Torres, C., Rodriguez Escudero, A., Lisson, R., Allemant Maldonado, A., Gallardo Rojas, W., Gonzales Bravo, L., Lema Osores, J., Farfan, J., Zapata, L., Godoy Junchaya, J., Roldan Concha, Y., Urquiaga Calderon, J., Sy, R., Tan, G., Aquitania, G., De Los Santos, G., Panelo, A., Roderos, O., Rosales, R., Toledo, R., Liwag, A., Ramoncito, H., Skokowska, E., Krzyzagorska, E., Ogorek, M., Wojnowski, L., Spyra, J., Konieczny, M., Piesiewicz, W., Kus, W., Ocicka-Kozakiewicz, A., Orlowska-Kunikowska, E., Zmuda, W., Duarte, S., Leitao, A., Monteiro, P., Rita, H., Salgado, V., Pinto, L., Queiros, J., Teixeira, J., Rogado, C., Duarte, R., Sobral do Rosario, F., Silva, A., Andrade, L., Velez, M., Brazao, M., Istratoaie, O., Lichiardopol, R., Catrinoiu, D., Militaru, C., Zetu, C., Barbonta, D., Cosma, D., Crisan, C., Pop, L., Esip, V., Khetagurova, F., Petrov, A., Arutyunov, G., Boyarkin, M., Agafyina, A., Vorokhobina, N., Petunina, N., Libov, I., Zalevskaya, A., Nikolaev, K., Barbarash, O., Potemkin, V., Bystrova, A., Krasilnikova, E., Barbarich, V., Chumakova, G., Tarasov, N., Meleshkevich, T., Zateyshchikov, D., Lantseva, O., Belenkiy, D., Obrezan, A., Rossolko, L., Fillipova, E., Yakhontova, P., Khokhlov, A., Tan, R., Sum, C., Chang, H., Distiller, L., Pretorius, M., Nortje, H., Mitha, E., Burgess, L., Blignaut, S., Venter, T., Moodley, R., Lombaard, J., Govind, U., Naidoo, V., Mookadam, M., Engelbrecht, J., Omar, M., Jurgens, J., Podgorski, G., Vawda, H., Naidoo, D., Emanuel, S., Roodt, A., Amod, A., Van Zyl, L., Segura, J., Brito, M., Fernandez-Cruz, A., Artola, S., Iglesias, R., Toural, E., Garcia-Ortiz, L., Saban, J., Mesa, J., Vidal, J., Linares, J., del Canizo, F., Rigla, M., Suarez, C., Llorente, I., Moreno, B., Antoli, A., Gomez Peralta, F., Iglesias, M., Pereg, V., de Teresa, L., Camafort, M., Trescoli, C., Satarasinghe, R., Somasundaram, N., Siyambalapitiya, S., Antonypillai, C., Bulugahapitiya, D., Medagama, U., Huang, C., Lu, Y., Hwang, J., Chiang, C., Wen, M., Chen, J., Lai, W., Chang, K., Wang, J., Yeh, H., Kriangsak, P., Deerochanawong, C., Suwanwalaikorn, S., Mangklabruks, A., Kaewsuwanna, P., Piyayotai, D., Iabluchanskyi, M., Samoylov, O., Godlevska, O., Kovalyova, O., Voloshyna, O., Tseluyko, V., Zotov, S., Vykhovanyuk, I., Dulgeroff, A., Mayfield, R., Zaniewski-Singh, M., Ullal, J., Aloi, J., De La Rosa, R., Mosely, J., Wittmer, B., Aronoff, S., Rosenfeld, J., Seidner, M., Warren, M., Fishman, N., Weiss, R., Arif, A., Sandberg, M., Lewis, D., Ball, E., Graf, R., Breton, C., Tamayo, R., Richards, R., Cefalu, W., Uwaifo, G., Zayour, D., Hoffman, J., Fitz-Patrick, D., Khan, B., Blaze, K., Bressler, P., Halpern, S., Chappell, D., Bergenstal, R., Cuddihy, R., Matfin, G., Freedman, Z., Gonzalez-Campoy, J., Lerman, S., Rendell, M., Sitar, S., Reeves, M., Howard, T., Soufer, J., Miranda-Palma, B., Laliotis, A., Shomali, M., Teltser, M., Hurley, D., Morawski, E., Cherlin, R., Houchin, V., Welch, M., Goytia-Leos, D., Syed, M., Kowaloff, E., Weinrauch, L., Peniston, J., Brockmyre, A., First, B., Feld, L., Huffman, D., Nassim, O., Gottschlich, G., Patel, A., Knopke, C., Hernandez, M., Diaz, J., Giugliano, G., Nicasio, J., Eagerton, D., Huntley, R., Reed, J., III, Magee, M., Hippert, R., Sofley, C., Jr., Alzohaili, O., Levins, P., Anspach, R., Shah, S., Brusco, O., Naidu, J., Lindenbaum, J., Jacks, R., Hammond, G., Arena, C., Saxman, K., Mach, M., Kerstein, H., Kereiakes, D., Wahlen, J., Wehmeier, K., Chaykin, L., Rothman, J., Fogelfeld, L., Stroger, John H., Jr., Bittar, N., Rosenstock, J., Kayne, D., Navarro, J., Colfer, H., Mokshagundam, S., Shandilya, L., Connery, L., Wysham, C., Dela Llana, A., Jardula, M., MacAdams, M., Flippo, G., Heurich, E., Curtis, C., Sanders, D., Rawls, R., Velazquez, F., Osea, E., Mahood, K., Feldman, G., Eder, F., Riley, E., Fowler, W., Jain, M., Shepard, M., Schear, M., Barker, B., Strout, C., Obiekwe, O., Shanik, M., Green, C., Blakney, E., Roberson, K., Bretton, E., Pish, R., Kaveh, K., Maynard, B., Barager, W., Soldyshev, R., Austin, B., Parmar, P., Simpson, R., Chauhan, A., Kasper, J., Burr, R., Patel, N., Mariano, H., Pluto, T., Bratcher, C., Juarez, M., Levinson, L., Awad, A., Longshaw, K., Hoffman, K., Richwine, R., Molter, D., Boscia, J., III, Kowalyk, S., Lemis, P., Liss, J., Orr, R., Riser, J., Wood, J., Ubani, A., Paine, W., Hassani, F., Miranda, F., Hansen, V., Hansen, Val R., Farris, N., Bowden, R., Ajani, D., Maw, K., Andersen, J., Bergman, B., Dunmyer, S., Brandon, D., Anderson, M., Bononi, P., Prawer, J., Seidman, B., Cruz, H., Wilks, K., DiSanto, L., Buynak, R., Christensen, T., Denker, P., Koppel, W., Stedman, M., Lewy-Alterbaum, L., Karim, S., Shapiro, J., Gardner, T., Oskin, T., Gabra, N., Malano, J., and EMPA REG OUTCOME Investigators
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riesgo ,compuestos de bencidrilo ,type 2 diabetes mellitus ,Original Contributions ,humanos ,Medizin ,030204 cardiovascular system & hematology ,blood pressure ,cardiovascular diseases ,hematocrit ,stroke ,0302 clinical medicine ,Glucosides ,glucósidos ,030212 general & internal medicine ,Myocardial infarction ,Stroke ,mediana edad ,anciano ,OUTCOMES ,Hazard ratio ,Middle Aged ,ISCHEMIC-STROKE ,Anesthesia ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Cardiology ,TRIAL ,Cardiology and Cardiovascular Medicine ,Life Sciences & Biomedicine ,Risk ,medicine.medical_specialty ,Clinical Sciences ,enfermedades cardiovasculares ,Clinical Neurology ,Placebo ,03 medical and health sciences ,Outcome Assessment (Health Care) ,Internal medicine ,medicine ,Empagliflozin ,Diabetes Mellitus ,Humans ,Hypoglycemic Agents ,accidente cerebrovascular ,Benzhydryl Compounds ,METAANALYSIS ,Aged ,Advanced and Specialized Nursing ,Science & Technology ,business.industry ,MORTALITY ,Type 2 Diabetes Mellitus ,medicine.disease ,Confidence interval ,Blood pressure ,hipoglicemiantes ,Peripheral Vascular Disease ,evaluación de resultados (asistencia sanitaria) ,Cardiovascular System & Cardiology ,Neurology (clinical) ,Neurosciences & Neurology ,business ,FOLLOW-UP - Abstract
Supplemental Digital Content is available in the text., Background and Purpose— In the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), empagliflozin added to standard of care in patients with type 2 diabetes mellitus and high cardiovascular risk reduced the risk of 3-point major adverse cardiovascular events, driven by a reduction in cardiovascular mortality, with no significant difference between empagliflozin and placebo in risk of myocardial infarction or stroke. In a modified intent-to-treat analysis, the hazard ratio for stroke was 1.18 (95% confidence interval, 0.89–1.56; P=0.26). We further investigated cerebrovascular events. Methods— Patients were randomized to empagliflozin 10 mg, empagliflozin 25 mg, or placebo; 7020 patients were treated. Median observation time was 3.1 years. Results— The numeric difference in stroke between empagliflozin and placebo in the modified intent-to-treat analysis was primarily because of 18 patients in the empagliflozin group with a first event >90 days after last intake of study drug (versus 3 on placebo). In a sensitivity analysis based on events during treatment or ≤90 days after last dose of drug, the hazard ratio for stroke with empagliflozin versus placebo was 1.08 (95% confidence interval, 0.81–1.45; P=0.60). There were no differences in risk of recurrent, fatal, or disabling strokes, or transient ischemic attack, with empagliflozin versus placebo. Patients with the largest increases in hematocrit or largest decreases in systolic blood pressure did not have an increased risk of stroke. Conclusions— In patients with type 2 diabetes mellitus and high cardiovascular risk, there was no significant difference in the risk of cerebrovascular events with empagliflozin versus placebo. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01131676.
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- 2017
11. Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease
- Author
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Yale, Jf, Bakris, G, Cariou, B, Nieto, J, David Neto, E, Yue, D, Wajs, E, Figueroa, K, Jiang, J, Law, G, Usiskin, K, Meininger, G, DIA3004 Study Group, Ansari, A, Arnouts, P, Assefi, A, Barreto, A, Barysheva, O, Bavanandam, S, Blaze, K, Bochenek, A, Bononi, P, Booth, W, Boyarkin, M, Burgess, L, Busch, K, Buse, J, Carranza, J, Cha, B, Chang, A, Clavel, S, Cockrell, Rc, Conway, J, Cook, W, Dande, A, De Los Rios MO, Deshmukh, V, Dobjanschi, C, Dotta, Francesco, Elliott, T, Ellis, G, Ferraro, R, Fishman, N, Fomin, V, Fraige Filho, F, Gagiu, R, Goh, Bl, Goldenberg, R, Gorriz, Jl, Gottschlich, G, Gouet, D, Grenfell, R, Griffin, C, Guarisco, M, Guerci, B, Henkel, E, Hramiak, I, Ison, R, Jadoul, M, Jang, H, Januszewicz, A, Kale, S, Karpova, I, Kaye, W, Kerstein, H, Kijanska, J, Kobalava, Z, Kong, N, Krasilnikova, E, Krebs, J, Kuczerowski, R, Kuzin, A, Kuzmenko, A, Laurens, W, Lim, Sk, Marasaev, V, Castelao, Am, Merker, L, Michlin, B, Morales, E, Motylev, I, Muse, D, Mutha, A, Neto, Ed, Nicholls, K, Niemetz, I, Iglesias, Jn, Ong, Lm, Onor, G, Packham, D, Petit, C, Piatti, M, Pirags, V, Poch, E, Ramirez, G, Riser, J, Roger, S, Ross, S, Rudolph, L, Sangumani, J, Schollum, J, Scott, R, Sebopa, B, Serafinceanu, C, Serusclat, P, Seufert, J, Siegmund, T, Silva, A, Skokowska, E, Smith, D, Sokolova, J, Solovyov, O, Steindorf, J, Stringam, S, Teterovska, D, Thivolet, C, Tytus, R, Vally, T, Van Vlem, B, Vercammen, C, Volkova, N, Warling, X, Winkler, L, Young, S, Zanella, Mt, and Zimmerer, M.
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Blood Glucose ,Male ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Urinary system ,Urology ,Renal function ,Blood Pressure ,Thiophenes ,Placebo ,Drug Administration Schedule ,Diabetic nephropathy ,chemistry.chemical_compound ,Endocrinology ,Double-Blind Method ,Glucosides ,Sodium-Glucose Transporter 2 ,Internal medicine ,Internal Medicine ,medicine ,Humans ,Hypoglycemic Agents ,Diabetic Nephropathies ,Canagliflozin ,Renal Insufficiency, Chronic ,Sodium-Glucose Transporter 2 Inhibitors ,Aged ,Creatinine ,business.industry ,Body Weight ,medicine.disease ,Treatment Outcome ,Blood pressure ,Diabetes Mellitus, Type 2 ,chemistry ,Disease Progression ,Female ,business ,Glomerular Filtration Rate ,Kidney disease ,medicine.drug - Abstract
Aim This study evaluated the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) and within a subset of Stage 3 chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] ≥30 and
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- 2014
12. Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME (R) trial
- Author
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Fitchett, David, Zinman, Bernard, Wanner, Christoph, Lachin, John M., Hantel, Stefan, Salsali, Afshin, Johansen, Odd Erik, Woerle, Hans J., Broedl, Uli C., Inzucchi, Silvio E., Aizenberg, D., Ulla, M., Waitman, J., De Loredo, L., Farias, J., Fideleff, H., Lagrutta, M., Maldonado, N., Colombo, H., Ferre Pacora, F., Wasserman, A., Maffei, L., Lehman, R., Selvanayagam, J., d'Emden, M., Fasching, P., Paulweber, B., Toplak, H., Luger, A., Drexel, H., Prager, R., Schnack, C., Schernthaner, G., Fliesser-Goerzer, E., Kaser, S., Scheen, A., Van Gaal, L., Hollanders, G., Kockaerts, Y., Capiau, L., Chachati, A., Persu, A., Hermans, M., Vantroyen, D., Vercammen, C., Van de Borne, P., Mathieu, C., Benhalima, K., Lienart, F., Mortelmans, J., Strivay, M., Vereecken, G., Keymeulen, B., Lamkanfi, F., Chacra, A., Eliaschewitz, F., Zanella, M., Faludi, A., Bertolami, M., Hayashida, C., Nunes Salles, J., Monte, O., Dinato, M., Manenti, E., Rassi, N., Halpern, A., Lima Filho, M., Ayoub, J., Felicio, J., Borges, J., Gross, J., Sgarbi, J., Betti, R., Tiburcio, A., Purisch, S., Schmid, H., Takahashi, M., Castro, M., Rea, R., Hissa, M., Geloneze Neto, B., Saraiva, J., Henein, S., Lochnan, H., Imran, S. A., Clayton, D., Bayly, K., Berlingieri, J., Boucher, P., Chan, Y., Gupta, M., Chehayeb, R., Ouellett, A., Ur, E., Woo, V., Zinman, B., St Amour, E., Terront Lozano, M., Yupanqui Lozno, H., Urina, M., Lopez Jaramillo, P., Jaramillo, N., Sanchez, G., Perez, G., Tusek, S., Mirosevic, G., Goldoni, V., Jurisic-Erzen, D., Balasko, A., Balic, S., Drvodelic-Sunic, E., Varzic, S. Canecki, Machkova, M., Weiner, P., Lastuvka, J., Olsovsky, J., Krarup, T., Ridderstrale, M., Tarnow, L., Boesgaard, T. Wellov, Lihn, A. Saetre, Christensen, P., Juhl, H., Urhammer, S., Lund, P., Adojaan, B., Jakovlev, U., Lanno, R., Lubi, M., Marandi, T., Gouet, D., Courreges, J., Zaoui, P., Choukroun, G., Petit, C., Formagne, L., Estour, B., Mabire, P., Daugenet, C., Lemarie, B., Clavel, S., Aure, P., Remaud, P., Halimi, J., Hadjadj, S., Couffinhal, T., Glonti, S., Metreveli, D., Lominadze, Z., Giorgadze, E., Burtchuladze, T., Javashvili, L., Kurashvili, G., Kurashvili, R., Virsaladze, D., Nadareishvili, L., Khomasuridze, A., Cahill, T., Green, F., MacRury, S., Waldron, M., Middleton, A., McKnight, J., Pearson, E., Butler, M., Choksi, M., Caldwell, I., Farmer, I., Wyatt, N., Patrick, J., O'Brien, I., Devers, M., Bousboulas, S., Pappas, S., Piaditis, G., Vryonidou, A., Tentolouris, N., Karamitsos, K., Manes, C., Benroubi, M., Avramidis, I., Ozaki, R., Tan, K., Siu, S., Tsang, C., Dudas, M., Nagy, K., Salamon, C., Ip, T., Geroo, L., Patkay, J., Tabak, A., Juhasz, F., Szentpeteri, I., Tamas, G., Ghaisas, N., Bantwal, G., Mohan, V., Gupta, J., Sadhu, N., Kulkarni, A., Garg, N., Reddy, S., Deshpande, N., Gutlapalli, K., Pillai, M., Premchand, R., Badgandi, M., Jain, S., Aravind, S., Shamanna, P., Pandey, A., Gupta, S., Pramono, B., Saksono, H. Dante, Agung, P., Wahono, S. Djoko, Suastika, K., Tanggo, Y., Juwana, Y., Siswanto, B., Adawi, F., Efrati, S., Mazen, E., Bashkin, A., Herskovits, T., Jaffe, A., Schiff, E., Wainstein, J., Taddei, S., Aiello, A., Arca, M., Calabro, P., Cignarelli, M., Fioretto, P., Reggiani, G. Marchesini, Gnasso, A., Marchionni, N., Marsilii, A., Bucci, M., Mezzetti, A., Pozzilli, P., Colivicchi, F., Santini, M., Moro, E., Toscano, V., Fucili, A., Semplicini, A., Monno, S., Furui, K., Higashiue, S., Hiramatsu, N., Kawamitsu, K., Takenaka, T., Takahashi, H., Hojo, F., Onishi, Y., Izumino, K., Okubo, M., Wakida, Y., Kondo, Y., Hieshima, K., Jinnouchi, H., Suzuki, A., Ito, M., Park, S., Kim, Y., Hong, T., Park, H., Gwon, H., Kim, H., Kang, K., Jeong, M., Seung, K., Lim, D., Rha, S., Tahk, S., Yang, J., Yoon, J., Shin, M., Kim, D., Jeong, J., Ahmad, N. Nik, Mustafa, N., Mohamed, W. Wan, Fung, Y., Ghani, R. Abdul, Chandramouli, A., Chee, K., Kadir, K. Abdul, Ling, K., Abu Hassan, M., Foo, S., Lee, S., Garcia Hernandez, P., Aguilar-Salinas, C., Vidrio Velazquez, M., Flores, F., Alpizar Salazar, M., Micher Escalante, D., Garcia Soria, M., Cardona Munoz, E., Storms, G., Schaper, N., Kooy, A., Krekels, M., van Bemmel, T., Verhoeven, R., Mulder, H., Oldenburg-Ligtenberg, P., Gonkel, F., de Jong, A., van Soest, J., Viergever, P., Mevissen, H., Lochorn, G., Zwiers, G., Hoogslag, P., Ronner, E., Nierop, P., Al-Windy, N., Kragten, J., Dekelver, P., Benatar, J., Krebs, J., Scott, R., Heggen, E., Berz, A., Fossum, C., Hurtig, U., Langslet, G., Baranowski, M., Sparby, J., Karlsson, T., Karlsson, Thomas, Delgado Torres, C., Rodriguez Escudero, A., Lisson, R., Allemant Maldonado, A., Gallardo Rojas, W., Gonzales Bravo, L., Lema Osores, J., Farfan, J., Zapata, L., Godoy Junchaya, J., Roldan Concha, Y., Urquiaga Calderon, J., Sy, R., Tan, G., Aquitania, G., De Los Santos, G., Panelo, A., Roderos, O., Rosales, R., Toledo, R., Liwag, A., Ramoncito, H., Skokowska, E., Krzyzagorska, E., Ogorek, M., Wojnowski, L., Spyra, J., Konieczny, M., Piesiewicz, W., Kus, W., Ocicka-Kozakiewicz, A., Orlowska-Kunikowska, E., Zmuda, W., Duarte, S., Leitao, A., Monteiro, P., Rita, H., Salgado, V., Pinto, L., Queiros, J., Teixeira, J., Rogado, C., Duarte, R., Sobral do Rosario, F., Silva, A., Andrade, L., Velez, M., Brazao, M., Istratoaie, O., Lichiardopol, R., Catrinoiu, D., Militaru, C., Zetu, C., Barbonta, D., Cosma, D., Crisan, C., Pop, L., Esip, V., Khetagurova, F., Petrov, A., Arutyunov, G., Boyarkin, M., Agafyina, A., Vorokhobina, N., Petunina, N., Libov, I., Zalevskaya, A., Nikolaev, K., Barbarash, O., Potemkin, V., Bystrova, A., Krasilnikova, E., Barbarich, V., Chumakova, G., Tarasov, N., Meleshkevich, T., Zateyshchikov, D., Lantseva, O., Belenkiy, D., Obrezan, A., Rossolko, L., Fillipova, E., Yakhontova, P., Khokhlov, A., Tan, R., Sum, C., Chang, H., Distiller, L., Pretorius, M., Nortje, H., Mitha, E., Burgess, L., Blignaut, S., Venter, T., Moodley, R., Lombaard, J., Govind, U., Naidoo, V., Mookadam, M., Engelbrecht, J., Omar, M., Jurgens, J., Podgorski, G., Vawda, H., Naidoo, D., Emanuel, S., Roodt, A., Amod, A., Van Zyl, L., Segura, J., Brito, M., Fernandez-Cruz, A., Artola, S., Iglesias, R., Toural, E., Garcia-Ortiz, L., Saban, J., Mesa, J., Vidal, J., Linares, J., del Canizo, F., Rigla, M., Suarez, C., Llorente, I., Moreno, B., Antoli, A., Gomez Peralta, F., Iglesias, M., Pereg, V., de Teresa, L., Camafort, M., Trescoli, C., Satarasinghe, R., Somasundaram, N., Siyambalapitiya, S., Antonypillai, C., Bulugahapitiya, D., Medagama, U., Huang, C., Lu, Y., Hwang, J., Chiang, C., Wen, M., Chen, J., Lai, W., Chang, K., Wang, J., Yeh, H., Kriangsak, P., Deerochanawong, C., Suwanwalaikorn, S., Mangklabruks, A., Kaewsuwanna, P., Piyayotai, D., Iabluchanskyi, M., Samoylov, O., Godlevska, O., Kovalyova, O., Voloshyna, O., Tseluyko, V., Zotov, S., Vykhovanyuk, I., Dulgeroff, A., Mayfield, R., Zaniewski-Singh, M., Ullal, J., Aloi, J., De La Rosa, R., Mosely, J., Wittmer, B., Aronoff, S., Rosenfeld, J., Seidner, M., Warren, M., Fishman, N., Weiss, R., Arif, A., Sandberg, M., Lewis, D., Ball, E., Graf, R., Breton, C., Tamayo, R., Richards, R., Cefalu, W., Uwaifo, G., Zayour, D., Hoffman, J., Fitz-Patrick, D., Khan, B., Blaze, K., Bressler, P., Halpern, S., Chappell, D., Bergenstal, R., Cuddihy, R., Matfin, G., Freedman, Z., Gonzalez-Campoy, J., Lerman, S., Rendell, M., Sitar, S., Reeves, M., Howard, T., Soufer, J., Miranda-Palma, B., Laliotis, A., Shomali, M., Teltser, M., Hurley, D., Morawski, E., Cherlin, R., Houchin, V., Welch, M., Goytia-Leos, D., Syed, M., Kowaloff, E., Weinrauch, L., Peniston, J., Brockmyre, A., First, B., Feld, L., Huffman, D., Nassim, O., Gottschlich, G., Patel, A., Knopke, C., Hernandez, M., Diaz, J., Giugliano, G., Nicasio, J., Eagerton, D., Huntley, R., Reed, J., III, Magee, M., Hippert, R., Sofley, C., Jr., Alzohaili, O., Levins, P., Anspach, R., Shah, S., Brusco, O., Naidu, J., Lindenbaum, J., Jacks, R., Hammond, G., Arena, C., Saxman, K., Mach, M., Kerstein, H., Kereiakes, D., Wahlen, J., Wehmeier, K., Chaykin, L., Rothman, J., Fogelfeld, L., Stroger, John H., Jr., Bittar, N., Rosenstock, J., Kayne, D., Navarro, J., Colfer, H., Mokshagundam, S., Shandilya, L., Connery, L., Wysham, C., Dela Llana, A., Jardula, M., MacAdams, M., Flippo, G., Heurich, E., Curtis, C., Sanders, D., Rawls, R., Velazquez, F., Osea, E., Mahood, K., Feldman, G., Eder, F., Riley, E., Fowler, W., Jain, M., Shepard, M., Schear, M., Barker, B., Strout, C., Obiekwe, O., Shanik, M., Green, C., Blakney, E., Roberson, K., Bretton, E., Pish, R., Kaveh, K., Maynard, B., Barager, W., Soldyshev, R., Austin, B., Parmar, P., Simpson, R., Chauhan, A., Kasper, J., Burr, R., Patel, N., Mariano, H., Pluto, T., Bratcher, C., Juarez, M., Levinson, L., Awad, A., Longshaw, K., Hoffman, K., Richwine, R., Molter, D., Boscia, J., III, Kowalyk, S., Lemis, P., Liss, J., Orr, R., Riser, J., Wood, J., Ubani, A., Paine, W., Hassani, F., Miranda, F., Hansen, V., Hansen, Val R., Farris, N., Bowden, R., Ajani, D., Maw, K., Andersen, J., Bergman, B., Dunmyer, S., Brandon, D., Anderson, M., Bononi, P., Prawer, J., Seidman, B., Cruz, H., Wilks, K., DiSanto, L., Buynak, R., Christensen, T., Denker, P., Koppel, W., Stedman, M., Lewy-Alterbaum, L., Karim, S., Shapiro, J., Gardner, T., Oskin, T., Gabra, N., Malano, J., EMPA-REG OUTCOME Trial, and EMPA-REG OUTCOME(R) trial investigators
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medicine.medical_specialty ,Cardiac & Cardiovascular Systems ,Aha Fasttrack ,BLOOD-PRESSURE ,030209 endocrinology & metabolism ,Cardiovascular disease ,Hospitalization ,Mortality ,Type 2 diabetes ,030204 cardiovascular system & hematology ,COLLABORATION ,GUIDELINES ,DOUBLE-BLIND ,MELLITUS ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Diabetes mellitus ,Empagliflozin ,Medicine ,ddc:610 ,Adverse effect ,Science & Technology ,COTRANSPORTER 2 INHIBITION ,business.industry ,MORTALITY ,Hazard ratio ,Heart Failure/Cardiomyopathy ,medicine.disease ,INSULIN ,Editor's Choice ,Endocrinology ,Blood pressure ,DISEASES ,SAFETY ,Heart failure ,Cardiovascular System & Cardiology ,Number needed to treat ,Cardiology ,Fast Track ,Cardiology and Cardiovascular Medicine ,business ,Life Sciences & Biomedicine - Abstract
Aims We previously reported that in the EMPA-REG OUTCOME(R) trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure. Methods and results Patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Seven thousand and twenty patients were treated; 706 (10.1%) had heart failure at baseline. Heart failure hospitalization or cardiovascular death occurred in a significantly lower percentage of patients treated with empagliflozin [265/4687 patients (5.7%)] than with placebo [198/2333 patients (8.5%)] [hazard ratio, HR: 0.66 (95% confidence interval: 0.55-0.79); P < 0.001], corresponding to a number needed to treat to prevent one heart failure hospitalization or cardiovascular death of 35 over 3 years. Consistent effects of empagliflozin were observed across subgroups defined by baseline characteristics, including patients with vs. without heart failure, and across categories of medications to treat diabetes and/or heart failure. Empagliflozin improved other heart failure outcomes, including hospitalization for or death from heart failure [2.8 vs. 4.5%; HR: 0.61 (0.47-0.79); P < 0.001] and was associated with a reduction in all-cause hospitalization [36.8 vs. 39.6%; HR: 0.89 (0.82-0.96); P = 0.003]. Serious adverse events and adverse events leading to discontinuation were reported by a higher proportion of patients with vs. without heart failure at baseline in both treatment groups, but were no more common with empagliflozin than with placebo. Conclusion In patients with type 2 diabetes and high cardiovascular risk, empagliflozin reduced heart failure hospitalization and cardiovascular death, with a consistent benefit in patients with and without baseline heart failure., This work was supported by Boehringer Ingelheim and Eli Lilly and Company. Boehringer Ingelheim was involved in the design and conduct of the study; collection, analysis, and interpretation of data; and preparation of this manuscript. Eli Lilly's involvement was limited to co-funding of the study. Funding to pay the Open Access publication charges for this article was provided by Boehringer Ingelheim.
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- 2016
13. Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes
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Parving, Hh, Brenner, Bm, Mcmurray, Jj, de Zeeuw, D, Haffner, Sm, Solomon, Sd, Chaturvedi, N, Persson, F, Desai, As, Nicolaides, M, Richard, A, Xiang, Z, Brunel, P, Pfeffer, Ma, Viberti, G, Lachin, Jm, Zinman, B, Pedersen, Tr, Villamil, As, Juncos, L, Prager, R, Verpooten, G, Zanella, Mt, Leiter, L, Pan, C, Wang, H, Botero, R, Cifkova, R, Christiansen, Js, Groop, Ph, Marre, M, Haller, H, Nickenig, G, Siamopoulos, K, Gero, L, Maggioni, A, Remuzzi, G, Katayama, Ss, Kim, Sg, Petrulioniene, Z, Lok, D, Kooy, A, Jorde, R, Medina, F, Polonia, J, Wong, Ks, Dukat, A, Rayner, Bl, Ruilope, L, Weiss, L, Wuethrich, R, Sheu, W, Sritara, P, Comlekci, A, Bilous, R, Toto, R, Jamerson, K, Carillo, E, Orias, M, Kuschnir, E, Rusculleda, M, Garcia, S, Farias, E, Lema, L, Hominal, M, Montaña, O, Sala, J, Diaz, M, Piskorz, D, Vita, N, Litwak, L, Sinay, I, Marin, M, Massari, P, Majul, C, Aizemberg, D, Azize, Gm, Bartolacci, I, Reboredo, A, Vico, M, Milesi, R, Sessa, H, Wassermann, A, Margulis, F, Zangroniz, P, Watschinger, B, Toplak, H, Paulweber, B, Drexel, H, Francesconi, C, Foeger, B, Mayer, G, Braun, Rk, Brath, H, Gaal, Lv, Niepen, Pv, Persu, A, Vercammen, C, Vriese, Ad, Coucke, F, Mathieu, C, Fery, F, Treille, S, Meeus, G, Acker, Kv, Scheen, A, Tits, J, Ruige, J, Krzesinski, Jm, Hollanders, G, Liénart, F, Dendale, P, Quinonez, M, Arnouts, P, Vanuytsel, J, Zanella, M, Mion D., Jr, Forti, A, Almeida, F, Cunha, R, de Paula RB, Brandao, A, Rocha, J, Krieger, E, Feitosa, G, Saraiva, J, Martin, J, Hissa, Mn, Schmid, H, Felicio, J, Sgarbi, J, Oigman, W, Bowering, K, Garceau, C, Berlingieri, Jc, Weisnagel, Sj, Hardin, P, Powell, C, Turcot, R, Muirhead, N, Aronson, R, Barima, Yt, Steele, Aw, Pandey, S, Woo, V, Cha, J, Dattani, D, Godin, C, Gupta, M, Saunders, K, Tellier, G, Ting, R, Tobe, S, Chouinard, G, Schlosser, R, Khandwala, H, Ekoe, Jm, Harris, Sb, Pichette, V, Lachance, P, Ooi, Tc, Tildesley, H, Barrett, B, Cournoyer, S, Lu, J, Zhang, H, Liu, X, Yan, S, Qi, X, Li, Q, Li, H, Lv, X, 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Y, Takeda, H, Shimizu, H, Yamada, T, Kojima, S, Zushi, S, Kaneko, S, Matsumoto, A, Kajiyama, S, Fujita, H, Shikata, K, Tone, A, Matsubayashi, S, Tanaka, S, Sekigami, T, Tatsukawa, Y, Abe, N, Kawahara, K, Kasahara, H, Maeda, Y, Suzuki, Y, Okamoto, H, Tachi, K, Yamada, K, Uzu, T, Itou, T, Fukui, T, Kim, S, Kim, Y, Cho, W, Kwak, I, Chae, D, Oh, H, Ha, S, Shin, Y, Cha, D, Kang, S, Lim, C, Song, J, Kwon, Y, Badariene, J, Labutiniene, Ip, Zabuliene, L, Poteliuniene, V, Miglinas, M, van den Meiracker AH, Gregoor, Pj, Luik, Aj, van Loon BJ, Feenstra, Hj, Kaasjager, Ha, Viergever, Pp, Woittiez, Aj, van Bemmel, T, Lieverse, Ag, Simsek, S, Gaillard, Ca, van der Zwaan, C, Lok, Dj, Spiering, W, Nierop, Pr, Baggen, Mg, Leendert, Rj, de Jong, A, Leurs, Pb, Vincent, Hh, Wins, Eh, Voors, Aa, Ronner, E, Heeg, Je, van Hal JM, Boermans, T, Feis, Wl, Mostard, G, Bakker, Rc, Dunselman, Ph, Skeie, S, Istad, H, Skjelvan, G, Gronert, J, Tomala, T, Gudnason, S, Torvik, Dt, Risberg, K, Abedini, S, Cabrera, W, 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Agarwal, N, Verma, S, Valitutto, M, Demetry, K, Mersey, J, Koeper, D, Fanti, P, Eng, G, Grimm, R, Fagan, T, Bajaj, M, Katz, L, Portnay, G, Altschuller, A, Desai, V, Bilazarian, S, Ipp, E, Rodelas, R, Burstein, D, Berg, J, Velez, J, Lund, R, Rekhi, A, Martin, E, Robertson, D, Singh, N, Narayan, P, Moustafa, M, Lanier, D, Seidner, M, Phillips, A, Vaughters, B, Sprague, A, Swartz, S, Lopez, R, Kumar, J, Bressler, P, Sadler, L, Wise, J, Kilbane, A., and Groningen Kidney Center (GKC)
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Male ,Hyperkalemia ,CARDIOVASCULAR MORTALITY ,BLOOD-PRESSURE ,Angiotensin-Converting Enzyme Inhibitors ,Type 2 diabetes ,GLOMERULAR-FILTRATION-RATE ,DOUBLE-BLIND ,chemistry.chemical_compound ,Fumarates ,cardiovascular disease ,Renin ,Treatment Failure ,Settore MED/49 - Scienze Tecniche Dietetiche Applicate ,610 Medicine & health ,diabetes ,Medicine (all) ,Hazard ratio ,aliskiren ,diabete ,trial clinico ,Liter ,General Medicine ,Middle Aged ,hypertension ,Cardiovascular Diseases ,Combination ,HEART-FAILURE ,Drug Therapy, Combination ,Female ,Kidney Diseases ,type 2 diabetes ,medicine.symptom ,Type 2 ,medicine.medical_specialty ,Patient Dropouts ,Urology ,Hypokalemia ,Aliskiren ,chronic kidney disease ,Placebo ,Angiotensin Receptor Antagonists ,LEFT-VENTRICULAR DYSFUNCTION ,Drug Therapy ,Double-Blind Method ,Diabetes Mellitus ,medicine ,Humans ,CONVERTING-ENZYME INHIBITORS ,Antihypertensive Agents ,Aged ,Amides ,Diabetes Mellitus, Type 2 ,Follow-Up Studies ,business.industry ,medicine.disease ,Confidence interval ,Surgery ,Blood pressure ,MYOCARDIAL-INFARCTION ,chemistry ,SYSTOLIC DYSFUNCTION ,FOLLOW-UP ,business - Abstract
BACKGROUND This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both. METHODS In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level. RESULTS The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P = 0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, = 6 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P CONCLUSIONS The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. (Funded by Novartis; ALTITUDE ClinicalTrials.gov number, NCT00549757.)
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- 2012
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14. Coping With Termination of Pregnancy for Fetal Abnormality in a Supportive Environment
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Geerinck-Vercammen, C. R., primary and Kanhai, H. H. H., additional
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- 2004
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15. Reply: Coping with termination of pregnancy
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Geerinck-Vercammen, C. R., primary and Kanhai, H. H. H., additional
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- 2004
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16. Coping with termination of pregnancy for fetal abnormality in a supportive environment
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Geerinck‐Vercammen, C. R., primary and Kanhai, H. H. H., additional
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- 2003
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17. Acanthosis nigricans Caused by Nicotinic Acid: Case Report and Review of the Literature
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Stals, H., primary, Vercammen, C., additional, Peeters, C., additional, and Morren, M.-A., additional
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- 1994
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18. Chronic complications versus glycaemic variability, time in range and HbA(1c) in people with type 1 diabetes: sub study of the RESCUE-trial
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El Malahi, A., Elsen, M., Charleer, S., Ridder, F., Ledeganck, K., Keymeulen, B., Crenier, L., Radermecker, R., Lapauw, B., Vercammen, C., Nobels, F., Mathieu, C., Pieter Gillard, and Block, C.
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Medicine and Health Sciences
19. Alogliptin after acute coronary syndrome in patients with type 2 diabetes
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White, W. B., Cannon, C. P., Heller, S. R., Nissen, S. E., Bergenstal, R. M., Bakris, G. L., Perez, A. T., Fleck, P. R., Mehta, C. R., Kupfer, S., Wilson, C., Cushman, W. C., Zannad, F., Aiub, J., Albisu, J., Alvarez, C., Astesiano, A., Barcudi, R., Bendersky, M., Bono, J., Bustos, B., Cartasegna, L., Caruso, O., Casabe, H., Castro, R., Colombo, H., Cuneo, C., Cura, F., Loredo, L., Dran, R., Fernandez, H., Garcia Pinna, J., Hrabar, A., Klyver Saleme, M., Luquez, H., Mackinnon, I., Maffei, L., Majul, C., Mallagray, M., Marino, J., Martinez, D., Martingano, R., Nul, D., Parody, M. L., Petrucci, J., Pieroni, M., Daniel Piskorz, Prado, A., Ramos, H., Resk, J., Rodriguez, M., Rojas, C., Sarjanovich, R., Sarries, A., Sessa, H., Silveiro, S., Sosa Liprandi, M. I., Tartaglione, J., Tonin, H., Vallejos, J., Vigo, S., Visco, V., Vita, N., Vogel, D., Vogelmann, O., Zaidman, C., Zangroniz, P., Colquhoun, D., Coverdale, S., Flecknoe-Brown, S., Hii, C. S., Roberts-Thomson, P., Drexel, H., Luger, A., Pieber, T., Cools, F., Ruige, J., Schoors, D., Vercammen, C., Wollaert, B., Alves Da Costa, F., Amodeo, C., Baggenstoss, R., Barbosa, E., Barroso Souza, W. K., Bassan, R., Borges, J. L., Botelho, R., Braile, M. C., Castello, H., Chrisman, C., Dos Santos, F., Faria Neto, J., Farsky, P., Fernandes Da Costa, A., Fraige Filho, F., Garbelini, B., Garcia, M. F., Garzon, P., Guimaraes, A. E., Herdy, A., Hernandes, M., Hilgemberg, S., Hissa, M., Jatene, J. A., Kormann, A., Leaes, P., Lima, F., Lisboa, H. R., Maia, L., Maia Da Silva, F., Maldonado Franco, D., Martin, J. F., Medeiros, A., Michalaros, Y., Miguel Leitao, A., Montenegro, S., Moraes Junior, J., Mota Gomes, M., Paiva, M. S., Precoma, D., Rabelo, A., Reis, G., Reis, H., Rossi, P., Saporito, W., Sarmento Leite, R., Silva, R. P., Silva Junior, D., Sousa, L., Sousa, A. C., Ueda, R., Vilas-Boas, F., Wainstein, M., Zago, A., Angelova, M., Apostolova, E., Daskalova, I., Delchev, A., Hristozov, K., Ilieva, M., Kovacheva, S., Lucheva, M., Temelkova, M., Toneva, A., Videva, V., Vuchkova, E., Bakbak, A., Carpentier, A., Chan, Y. K., Cheema, A., Chouinard, G., Conway, J., Dery, J. P., Dowell, A., Frechette, A., Jakubowski, M., Kelly, A., Ma, P., Maung, T. Z., Mehta, S., Parker, D., Pesant, Y., Polasek, P., Ransom, T., Syan, G., Vizel, S., Albornoz, F., Castro Galvez, P., Cobos, J. L., Conejeros, C., D Acuña Apablaza, M., Fajardo, G., Illanes Brochet, G., Lazcano, M. O., Pincetti, C., Potthoff, S., Raffo, C., Saavedra, V., Schnettler, M., Sepulveda, P., Stockins, B., Vejar, M., Accini, J. L., Cotes Aroca, C. H., Fernandez Ruiz, R. L., Orozco Linares, L. A., Vesga Angarita, B. E., Aganovic, I., Bagatin, J., Canecki-Varzic, S., Erzen, D. J., Knezevic, A., Maric, A., Milicevic, G., Popovic, Z., Rubes, J., Weiss, S. S., Dresslerova, I., Havelkova, J., Kucera, D., Machacek, J., Pumprla, J., May, O., Perrild, H., Aziz, M. A., El Badry, M., Hasanein, M., Airaksinen, J., Laine, M., Nyman, K., Vikman, S., Bonnet, J., Elbaz, M., Henry, P., Paillard, F., Petit, C., Tropeano, A. I., Behnke, T., Bornstein, S., Busch, K., Ebelt, H., Faghih, M., Fischer, H., Heuer, H., Paschke, R., Porner, T. C., Tangerding, G., Vöhringer, H. F., Adamson, K., Beatt, K., Bellary, S., Chapman, J., Cooke, A., Fisher, M., Gnudi, L., Jones, H., Kumar, S., Nagi, D., Oldroyd, K., Richardson, T., Robertson, D., Robinson, A., Saravanan, P., Viljoen, A., Wilding, J., Wilkinson, P., Wong, Y. K., Zoupas, C., Arango, J., Castellanos, J., Ceren Flores, C., Corona, V., Granados-Fuentes, A., Haase, F., Montenegro, P., Prado, J. H., Villalobos, R., Chow, F., Li, S. K., Li, J., Yan, P. Y., Yeung, V., Abel, T., Benedek, A., Dezso, E., Dudas, M., Édes, I., Fulop, G., Kovács, A., Lupkovics, G., Merkely, B., Nagy, A., Oroszlan, T., Palinkas, A., Papp, A., Patkay, J., Simon, E., Sitkei, E., Tabak, A., Tomcsányi, J., Abdullakutty, J., Abhyankar, A., Akalkotkar, U., Alexander, T., Arneja, J., Aslam, N., Babu, P. R., Babu, B. R., Banker, D., Bantwal, G., Bhimashankar, P. R., Calton, R. K., Chopda, M., Dande, A., Dani, S., Deshpande, N., Dhanwal, D., Dharmadhikari, A., Gadkari, M., Garg, N., Ghaisas, N., Goyal, N. K., Gupta, J. B., Jawahirani, A., Joseph, S., Kumar, R., Kumble, M., Mathavan, A., Mathur, A., Mohanan, P. P., Nair, A., Nair, T., Namjoshi, D., Pinto, R., Prakash, G., Purushotham, R., Raju, S., Ramachandran, P., Ramesh, S. S., Rao, B., Ravikishore, A., Reddy, G. R., Roy, S., Sadhu, N., Sastry, B. K., Singh, P., Srinivas, A., Thacker, H., Thanvi, S., Thomas, J., Adawi, F., Bashkin, A., Cohen, J., Harman-Boehm, I., Hasin, Y., Hayek, T., Iakobishvili, Z., Katz, A., Kracoff, O., Minuchin, O., Moriel, M., Mosseri, M., Omary, M., Wainstein, J., Weiss, A., Zeltser, D., Calabro, P., Derosa, G., Genovese, S., Novo, S., Olivieri, C., Piatti, P., Violini, R., Volpe, M., Ajioka, M., Amano, T., Arasaki, O., Daida, H., Fujimoto, K., Fujinaga, H., Higashiue, S., Hirohata, A., Hosokawa, S., Ikefuji, H., Inagaki, M., Iseki, H., Iwabuchi, M., Iwasaki, T., Kakishita, M., Katsuda, Y., Kawada, K., Kawajiri, K., Kawamitsu, K., Kobayashi, K., Komada, F., Komura, Y., Machida, M., Maemura, K., Matsubara, T., Matsubayashi, S., Matsumoto, T., Matsumoto, N., Mima, T., Miyamoto, N., Momiyama, Y., Morimoto, T., Murakami, M., Nakashima, E., Niijima, Y., Noda, T., Node, K., Nozaki, A., Nunohiro, T., Ogawa, T., Ono, Y., Saeki, T., Sakota, S., Sakuragi, S., Sasaki, T., Sato, Y., Sueyoshi, A., Suzuki, M., Takagi, G., Tanabe, J., Tanaka, S., Tei, I., Yamamoto, M., Yanagihara, K., Hong, T. J., Jeon, H. K., Kang, D. H., Kim, C. H., Kim, D. S., Kim, H. S., Kim, J. H., Kim, S. K., Kim, W. S., Kim, Y. K., Lee, S. R., Lee, K. W., Park, H. S., Pyun, W. B., Rha, S. W., Yoon, J., Yoon, K. H., Bennakhi, A., Geldnere, K., Sokolova, J., Teterovska, D., Dautaraite, V., Kakariekiene, V., Kavaliauskiene, R., Kucinskiene, A., Lasiene, J., Mickuviene, N., Palinauskas, A., Urboniene, A., Zilaitiene, B., Abdul Manap, H., Abidin, I. Z., Isa, S. H., Khir, A. M., Ng, K. H., Tan, F., Yusof, Z., Yusoff, K., Zambahari, R., Aguila-Marin, J., Aguilera Real, M., Alvarado-Ruiz, R., Alvarez Lopez, H., Arenas Leon, J., Bayram Llamas, E. A., Calvo Vargas, C., Carrillo Calvillo, J., Los Rios Ibarra, M., Dominguez-Reyes, C. A., Duarte, M., Elizondo, E., Fajardo Campos, P., Fanghanel-Salmon, G., Figueroa Sauceda, S., Gallegos Martinez, J., Garcia-Cantu, E., Garza Ruiz, J. A., Gonzalez Gonzalez, J. G., Guerrero Garza, M., Hernandez Herrera, C., Hernandez Munuzuri, J., Hernandez-Garcia, H., Jimenez Ramos, S., Laviada Molina, H., Lopez Villezca, D., Montano-Gonzalez, E., Nevarez Ruiz, L., Ramos Lopez, G., Reyes Araiza, R., Salazar-Gaytan, A., Salcido Vazquez, E., Sanchez Mijangos, H., Solis Morales, L., Benatar, J., Dixon, P., Nirmalaraj, K., Rosen, I., Scott, R., Young, S., Araoz Tarco, O., Barreda Cáceres, L., Benites Lopez, C., Camacho Cosavalente, L., Chavez Huapalla, E., Chois Malaga, A., Copaja Flores, A., Farfan Aspilcueta, J., Gallardo Rojas, W., Gallegos Cazorla, A., Galvez Caballero, D., Garcia Matheus, J., Garrido Carrasco, E., Gomez Sanchez, J., Hernandez Zuniga, J., Lu Galarreta, L., Luna, A., Manrique Hurtado, H., Orihuela Pastor, B., Pando Alvarez, R. M., Sanchez Povis, J., Torres Eguiluz, P., Valdivia Portugal, A., Vargas Gonzales, R., Zapata Rincon, L., Aquitania, G., Fortinez, J. T., Go, A., Gomez, M. H., Habaluyas, R., Jasul, G., Magno, M., Manalo, C. J., Mirasol, R., Morales-Palomares, E., Salvador, D. R., Sy, R. A., Tirador, L., Yao, C., Arciszewska, M., Bartkowiak, R., Czajkowska-Kaczmarek, E., Gil, R., Gniot, J., Janik, K., Janion, M., Jaworska, K., Jozwa, R., Kawecka-Jaszcz, K., Kawka-Urbanek, T., Kondys, M., Korecki, J., Korzeniak, R., Kowalisko, A., Krzeminska-Pakula, M., Kwiecien, J., Nessler, J., Odrowaz-Pieniazek, P., Piepiorka, M., Rajzer, M., Skokowska, E., Spyra, J., Sroka, M., Stasinska, T., Szymczyk, I., Trznadel-Morawska, I., Wysokinski, A., Mateus, P., Matos, P., Mimoso, J., Monteiro, P., Caballero, B., Garcia-Rinaldi, R., Gonzalez, E., Ortiz-Carrasquillo, R., Roman, A., Sierra, Y., Unger, N., Vazquez-Tanus, J., Alexandru, T., Busegeanu, M., Cozman, D. C., Fica, S., Minescu, B., Morosanu, M., Negrisanu, G. D., Pintilei, E., Pop, L., Szilagyi, I., Teodorescu, I., Tomescu, M., Barbarash, O., Chumakova, G., Churina, S., Dogadin, S., Dvoryashina, I., Esip, V., Glezer, M., Gordeev, I., Gordienko, A., Gratsiansky, N., Grineva, E., Khasanov, N., Kostenko, V., Meleshkevich, T., Mikhin, V., Morugova, T., Motylev, I., Nikolaev, K., Ponomareva, A., Repin, M., Reshetko, O., Shustov, S., Shutemova, E., Shvarts, Y., Simanenkov, V., Sobolev, K., Sukmanova, I., Timofeev, A., Tsyba, L., Varvarina, G., Vertkin, A., Vishnevsky, A., Volkov, D., Vorobiev, S., Vorokhobina, N., Yakhontov, D., Zonova, E., Zrazhevskiy, K., Damjanovic, S., Djordjevic, D., Pavlovic, M., Perunicic, J., Ristic, A., Stojkovic, S., Tasic, N., Bolvanska, N., Buganova, I., Dulkova, K., Dzupina, A., Fulop, P., Gergel, V., Kokles, M., Micko, K., Svoren, P., Urban, M., Vadinova, S., Vargova, A., Burgess, L., Coetzee, K., Du Toit, J., Gani, M., Joshi, P., Naiker, P., Nortje, H., Sarvan, M., Seeber, M., Siebert, M., Zyl, L., Wellmann, H., Calvo, C., La Hera, J., Teresa, L., Melero-Pita, A., Mesa, J., Parra Barona, J., Serrano, P., Soto, A., Tofe, S., Hornestam, B., Kempe, A., Rosenqvist, U., Rydberg, E., Tengmark, B. O., Torstensson, I., Chang, C. T., Hsia, T. L., Hsieh, I. C., Lai, W. T., Wu, C. J., Hutayanon, P., Kosachunhanun, N., Marapracertsak, M., Piamsomboon, C., Seekaew, S., Srimahachota, S., Sukhum, P., Suraamornkul, S., Tantiwong, P., Wongvipaporn, C., Amosova, K., Barna, O., Bazylevych, A., Berenfus, V., Dyadyk, A., Fushtey, I., Gyrina, O., Iabluchanskyi, M., Karpenko, O., Kaydashev, I., Korzh, O., Kulynych, R., Legkonogov, O., Mankovsky, B., Mostovoy, Y., Parkhomenko, O., Popik, G., Rudenko, L., Rudyk, I., Shevchuk, S., Sirenko, Y., Suprun, Y., Tryshchuk, N., Tseluyko, V., Vakaliuk, I., Al Mahmeed, W., Acheatel, R., Ahmad, A., Akbar, S., Akhter, F., Albirini, A., Alexander, A., Al-Joundi, B., Al-Joundi, T., Allen, G., Aloi, J., Alvarado, O., Alzohaili, O., Anderson, C., Arastu, A., Arena, C., Argoud, G., Ariani, M., Arora, C., Awasty, V., Barker, B., Barnum, O., Bartkowiak, A. J., Barzilay, J., Behrens, P., Belledonne, M., Bergman, B., Bilnoski, W., Bisognano, J., Bissette, S., Blumberg, E., Bonabi, N., Bradley, A., Breton, C., Britos, M., Broadstone, V., Budoff, M., Burge, M., Butman, S., Carroll, M., Challappa, K., Chepuri, V., Cherlin, R., Cheung, D., Coats, P., Collins, J., Cruz, H., Daboul, N., Damberg, G., David, W., Dean, J., Dedeke, E., Deeb, W., Dehaven, J., Dobs, A., Donelan, T., Dy, J., Dykstra, G., Eisen, H., Farris, N., Fattal, P., Fishman, N., Foster, M., Fredrickson, S., Gabra, N., Gabriel, J., Gatien, L., Giddings, S., Ginsberg, B., Gips, S., Glandt, M., Goldfein, A., Gordon, M., Gould, R., Graf, R., Graham, B., Graves, M., Grena, P., Hahn, R., Hamilton, D., Hamroff, G., Hanke, F., Haque, I., Harper, J., Harris, A., Harris, S., Henson, B., Hermanns, D., Herndon, W., Hershberger, V., Hyman, D., Isserman, S., Iteld, B., Jacob, M., Jaffrani, N., Jamal, A., Johnson, D., Johnson, G., Kaluski, E., Keller, R., Kereiakes, D., Khan, M., Khan, S., Klein, M., Knutson, T., Korban, E., Kozinn, M., Kraft, P., Kroeze, J., Kukuy, E., Lader, E., Laliotis, A., Lambert, C., Landau, C., Latif, K., Lee, K., Lester, F., Levenson, D., Levinson, D., Lewis, D., Litt, M., Littlefield, R., Lo, E., Lovell, C., Mahal, S., Makam, S., Mandviwala, M., Marar, I., Masri, B., Mattson, S., Mays, M., Mcgrew, F., Meengs, M., Mikell, F., Miller, M., Miranda, F., Moll, D., Multani, P., Munuswamy, K., Nallasivan, M., Nayles, L., Ong, S., Pacheco, T., Paez, H., Patel, S., Phillips, R., Pierpont, B., Prasad, J., Quinlan, E., Quion, J., Qureshi, M., Rahman, A., Raikhel, M., Ramanathan, K., Randhawa, P., Ravi, R., Reddy, R., Rendell, M., Rickner, K., Rictor, K., Rivas, J., Rosenblit, P., Rosenstock, J., Ross, S., Salacata, A., Saririan, M., Schima, S., Schlau, A., Schmedtje, J., Scott, C., Scott, D., Serru-Paez, A., Shah, R., Shah, A., Shaoulian, E., Shomali, M., Shubrook, J., Silver, K., Singh, S., Speer, J., Stevens, J., Stringam, S., Taussig, A., Taylor, A., Tee, H., Teixeira, G., Tilley, A., Toggart, E., Twahirwa, M., Unks, D., Vakili, B., Vora, K., Wang, X., Warner, A., Wefald, F., Weinberg, B., Weinstein, D., White, L., Wu, P., Yasuda, T., Yazdani, S., Yetman, C., Zarich, S., Zebrack, J., Fonseca, V. A., Mccullough, P. A., Desouza, C., Goff, D. C., Harrell, F. E., Menon, V., Sila, C., Kalahasti, V., Ahmed, S., Al Solaiman, F., Bennett, M., Cavender, M., Heil, B., Katzan, I., Monteleone, P., O Brien, B., Oommen, S., Senn, T., Sharma, J., Stegman, B., Uchino, K., Zishiri, E., Pasca, N., Brown, K., Scebbi, T., Atanasovski, I., Mccue, M., Streit, J., Oh, R., Bueno, O., Lee, D., Camisasca, R., Miyata, Y., Rubin, A., Williamson, N., Vara, S., Keeter, K., Ross, B., Los Reyes, A., Donnelly, J., Koshy-Hunt, S., Beers, B., Black, S., Buckley, M., Ephrem, M., Riley, B., West, N., Harre, M., Hsieh, R., Oshinyemi, K., Oka, Y., Matsui, N., Hoang, M., Doyle, C., Koziol, M., Lam, H., Edmonds, A., Azooz, W., Cao, C., Kim, D., Boeshaar, A., Dewindt, A., Nicholson, K., Smith, N., Hisada, M., Harding, S., Yoshioka, N., Gujral-Sandhu, K., Gans, J., Gresk, C., Kujawski, M. R., Villinski, A., Cosner, S., Johannsen, C., Barchha, N., and Knapp, B.
20. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial
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Adrian F Hernandez, Jennifer B Green, Salim Janmohamed, Ralph B D'Agostino, Christopher B Granger, Nigel P Jones, Lawrence A Leiter, Anne E Rosenberg, Kristina N Sigmon, Matthew C Somerville, Karl M Thorpe, John J V McMurray, Stefano Del Prato, John J.V. McMurray, Ralph B. D'Agostino, Christopher B. Granger, Adrian F. Hernandez, Lawrence A. Leiter, Robert M Califf, Rury Holman, David DeMets, Matthew Riddle, Shaun Goodman, Darren McGuire, Karen Alexander, Adam Devore, Chiara Melloni, Chetan Patel, David Kong, Gerald Bloomfield, Matthew Roe, Pierluigi Tricoci, Rob Harrison, Renato Lopes, Robin Mathews, Rajendra Mehta, William Schuyler Jones, Sreekanth Vemulapalli, Thomas Povsic, Zubin Eapen, Keith Dombrowski, Brad Kolls, Dedrick Jordan, Andrew Ambrosy, Stephen Greene, Aditya Mandawat, Jay Shavadia, Lauren Cooper, Abhinav Sharma, Patricia Guimaraes, Daniel Friedman, Matt Wilson, Patricia Endsley, Tracy Gentry, Jeannie Collier, Kathleen Perez, Kourtnei James, Jennifer Roush, Connie Pope, Christina Howell, Megan Johnson, Matt Bailey, Joanna Cole, Teresa Akers, Beth Vandyne, Betsy Thomas, Jenny Rich, Susan Bartone, Gail Beaulieu, Kim Brown, Tuan Chau, Tamra Christian, Rebecca Coker, Deb Greene, Trevorlyn Haddock, Wendy Jenkins, Ghazala Haque, Marsha Marquess, Jean Pesarchick, Renee Rethaford, Allegra Stone, Firas Al Kawas, Michelle Anderson, Robert Enns, Isaac Sinay, Chantal Mathieu, Victor Yordanov, Irene Hramiak, Martin Haluzik, Søren Galatius, Bruno Guerci, Michael Nauck, Ilias Migdalis, Choon Beng Kathryn Tan, Gyozo Kocsis, Andrea Giaccari, Moon Kyu Lee, Ernesto German Cardona Muñoz, Jan Cornel, Kare Birkeland, Miguel Pinto, Louie Tirador, Martyna Olesinska-Mader, Marina Shestakova, Larry Distiller, Jose Lopez-Sendon, Bjorn Eliasson, Chern-En Chiang, Suphot Srimahachota, Boris Mankovsky, M Angelyn Bethel, Kathleen Dungan, Mikhail Kosiborod, Andres Alvarisqueta, Jorge Baldovino, Diego Besada, Pedro Calella, Maria Cecilia Cantero, Patricia Castaño, Alejandro Chertkoff, Jesus Cuadrado, Luis De Loredo, Andrea Dominguez, Maria Vanesa Español, Hernan Finkelstein, Gustavo Frechtel, Jose Fretes, Natalia Garrido Santos, Joaquin Gonzalez, Marcos Litvak, Juan Loureyro, Laura Maffei, Natacha Maldonado, Diego Mohr Gasparini, Silvia Orio, Federico Perez Manghi, Nelson Rodriguez Papini, Jorgelina Sala, Pablo Schygiel, Georgina Sposetti, Maria Ulla, Fernando Verra, Silvina Zabalua, Cesar Zaidman, Laurent Crenier, Corinne Debroye, Francis Duyck, André Scheen, Luc Van Gaal, Chris Vercammen, Velichka Damyanova, Stefan Dimitrov, Snezhina Kovacheva, Lachezar Lozanov, Viktor Margaritov, Rositsa Mihaylova-Shumkova, Antoaneta Nikolaeva, Zhasmina Stoyanova, Ronald Akhras, Yves Beaudry, Jacques Bedard, Joseph Berlingieri, Raja Chehayeb, Stephen Cheung, James Conway, Jean Cusson, Anthony Della Siega, Richard Dumas, Peter Dzongowski, Murdo Ferguson, Daniel Gaudet, Francois Grondin, Anil Gupta, Milan Gupta, Frank Halperin, Pierre-Alain Houle, Michael Jones, Simon Kouz, Christopher Kovacs, Daniel Landry, Eva Lonn, William O'Mahony, Sean Peterson, Dennis Reich, Alan Rosenbloom, Francois St-Maurice, Barna Tugwell, Saul Vizel, Vincent Woo, Tomas Brychta, Vladimir Cech, Eva Dvorakova, Tomas Edelsberger, Katarina Halciakova, Jarmila Krizova, Jiri Lastuvka, Martin Piperek, Vera Prymkova, Lea Raclavska, Elena Silhova, Robin Urbanek, Jan Vrkoc, Ulla Andersen, Jens Brønnum-Schou, Jens Hove, Jan Skov Jensen, Lars Kober, Ole Peter Kristiansen, Per Lund, Thomas Melchior, Ole Nyvad, Morten Schou, Alain Boye, Didier Cadinot, Didier Gouet, Patrick Henry, Laurence Kessler, Jean-Daniel Lalau, Catherine Petit, Jean-Francois Thuan, Christel Voinot, Julien Vouillarmet, Christoph Axthelm, Dirk Berger, Tasso Bieler, Andreas Birkenfeld, Jochen Bott, Klaus Busch, Karel Caca, Julia Chevts, Torsten Donaubauer, Rudolf Erlinger, Klaus Funke, Josef Grosskopf, Andreas Hagenow, Monika Hamann, Manfred Hartard, Peter Heymer, Wolfgang Huppertz, Gabriele Illies, Stephan Jacob, Thomas Jung, Gerd Kahrmann, Petra Kast, Monika Kellerer, Hans-Peter Kempe, Andrei Khariouzov, Gerhard Klausmann, Christiane Klein, Uwe Kleinecke-Pohl, Klaus Kleinertz, Thorsten Koch, Christine Kosch, Babette Lorra, Joerg Luedemann, Matthias Luttermann, Stephan Maxeiner, Karsten Milek, Andrea Moelle, Gerhard Neumann, Ruth Nischik, Edith Oehrig-Pohl, Georg Plassmann, Lars Pohlmeier, Felix Proepper, Stefan Regner, Werner Rieker, Ludger Rose, Holger Samer, Joachim Sauter, Frank Schaper, Clemens Schiffer, Juergen Schmidt, Bernd-M. Scholz, Joerg Schulze, Alexander Segner, Jochen Seufert, Helena Sigal, Joerg Steindorf, Juergen Stockhausen, Petra Stuebler, Heidrun Taeschner, Dietrich Tews, Diethelm Tschoepe, Karl Wilhelm, Helga Zeller-Stefan, Iakovos Avramidis, Stavros Bousboulas, Magdalini Bristianou, Georgios Dimitriadis, Moses Elisaf, Kalliopi Kotsa, Andreas Melidonis, Asimina Mitrakou, Emmanouil Pagkalos, Nikolaos Papanas, Angelos Pappas, Christos Sampanis, Nikolaos Tentolouris, Apostolos Tsapas, Glykeria Tzatzagou, Risa Ozaki, Csaba Hajdú, Eleonóra Harcsa, Laszlo Konyves, János Mucsi, Zsolt Pauker, Gizella Petró, Zsolt Plés, Katalin Revesz, Vangel Sándor, Viktor Vass, Angelo Avogaro, Massimo Boemi, Riccardo Bonadonna, Agostino Consoli, Salvatore De Cosmo, Paolo Di Bartolo, Francesco Dotta, Simona Frontoni, Marianna Galetta, Alessandra Gambineri, Carmine Gazzaruso, Francesco Giorgino, Davide Lauro, Emanuela Orsi, Giuseppe Paolisso, Gabriele Perriello, Piermarco Piatti, Antonio Pontiroli, Paola Ponzani, Angela Albarosa Rivellese, Giorgio Sesti, Giancarlo Tonolo, Roberto Trevisan, Chul Woo Ahn, Sei-Hyun Baik, Bong-Soo Cha, Choon-Hee Chung, Hak Chul Jang, Chong-Jin Kim, Hye Soon Kim, In Joo Kim, Eun Young Lee, Hyoung Woo Lee, Kwan-Woo Lee, Keon-Woong Moon, June Namgung, Kyong Soo Park, Soon Jib Yoo, Jaemyung Yu, Edmundo-Alfredo Bayram Llamas, Jose-Luis Cervantes-Escárcega, Luis Fernando Flota-Cervera, José Gerardo González-González, Sara Pascoe-Gonzalez, Emilia Susana Pelayo-Orozco, Santiago-Paulino Ramirez-Diaz, Arturo Saldana-Mendoza, Carlos Sánchez Jerjes-Díaz, Jose Juan Torres-Colores, Maricela Vidrio-Velázquez, Juan Villagordoa-Mesa, Hugo Peter Beijerbacht, Reginald G.E.J. Groutars, Boudewijn A Hoek, Pieter A.M. Hoogslag, Adriaan Kooy, Johannes A. Kragten, Aloysius G. Lieverse, Hendrik P. Swart, Eric P. Viergever, Jørn Ahlqvist, John Cooper, Hanne Gulseth, Gaute Guttormsen, Cecilie Wium, Hugo Arbañil, Jorge Calderon, Luis Camacho, Augusto Dextre Espinoza, Elizabeth Garrido, Alejandro Luna, Helard Manrique, Frederick Massucco Revoredo, Rolando Vargas Gonzales, Luis Zapata Rincon, Carlos Zubiate, Geraldine Ebo, Ellen Morales-Palomares, Malgorzata Arciszewska, Marek Banach, Renata Bijata-Bronisz, Tadeusz Derezinski, Waldemar Gadzinski, Jacek Gajek, Katarzyna Klodawska, Ewa Krzyzagorska, Andrzej Madej, Pawel Miekus, Jaroslaw Opiela, Piotr Romanczuk, Anna Siegel, Ewa Skokowska, Andrzej Stankiewicz, Teresa Stasinska, Iwona Trznadel-Morawska, Robert Witek, Sergey Aksentyev, Irina Bondar, Irina Demidova, Alexander Dreval, Olga Ershova, Gagik Galstyan, Alla Garganeeva, Nadezhda Izmozherova, Victoria Karetnikova, Marina Kharakhulakh, Aleksandr Khokhlov, Zhanna Kobalava, Olga Koshelskaya, Elena Kosmacheva, Vladimir Kostin, Natalia Koziolova, Anatoly Kuzin, Victor Lesnov, Tatyana Lysenko, Valentin Markov, Alexander Mayorov, Sergey Moiseev, Svetlana Myasoedova, Nina Petunina, Andrey Rebrov, Ludmila Ruyatkina, Julia Samoylova, Olga Sazonova, Natalia Shilkina, Nadezhda Sokolova, Olga Vasilevskaya, Nelli Verbovaya, Elena Vishneva, Sergey Vorobyev, Natalya Vorokhobina, Olga Zanozina, Elena Zhdanova, Tatyana Zykova, Lesley Burgess, Kathleen Coetzee, Saleem Dawood, Landman Lombard, Ellen Makotoko, Rajendran Moodley, Wessels Oosthuysen, Mohamed Sarvan, Carlos Calvo Gómez, Isidoro Cano Rodríguez, Almudena Castro Conde, Angel Cequier Fillat, Guillem Cuatrecasas Cambra, Fernando de Álvaro Moreno, Luis De Teresa Parreño, Javier Delgado Lista, José Ramón Domínguez Escribano, Santiago Durán García, Javier Elvira González, José María Fernández Rodríguez, Alberto Goday Arno, Ricardo Gomez Huelgas, José Ramón González Juanatey, Antonio Hernandez Mijares, Víctor Alfonso Jiménez Díaz, Esteban Jodar Gimeno, Tomás Lucas Morante, Monica Marazuela, Nieves Martell Claros, Didac Mauricio Puente, Elena Mena Ribas, Juan Francisco Merino Torres, Pedro Mezquita Raya, Andreu Nubiola Calonge, Xavier Ordoñez Sánchez, Jose Maria Pascual Izuel, Verónica Perea Castilla, Antonio Pérez Pérez, Isabel Perez Soto, Miguel Quesada Charneco, Angustias Quesada Simón, Josep Redón Mas, Antonia Rego Iraeta, Maria Rodriguez Alvarez, Irene Rodríguez Rodríguez, José Sabán Ruiz, Alfonso Soto González, Francisco Tinahones Madueno, Carlos Trescoli Serrano, Angels Ulied Armiñana, Erasmus Bachus, Katarina Berndtsson Blom, Ken Eliasson, Pekka Koskinen, Hans Larnefeldt, Cornelia Lif-Tiberg, Carina Linderfalk, Gustav Lund, Pia Lundman, Linda Moris, Åke Olsson, Staffan Salmonsson, Johan Sanmartin Berglund, Folke Sjöberg, Stefan Söderberg, Ingemar Torstensson, Jung-Fu Chen, Kai Jen Tien, Shih-Ting Tseng, Shih-Te Tu, Chih-Yuan Wang, Ji-Hung Wang, Arintaya Phrommintikul, Sukit Yamwong, Woravut Jintapakorn, Pisit Hutayanon, Nakarin Sansanayudh, Larysa Bazhan, Ivan Fushtey, Mariya Grachova, Vitaliy Katerenchuk, Vadym Korpachev, Nonna Kravchun, Oleksandr Larin, Galyna Mykhalchyshyn, Halyna Myshanych, Olga Oleksyk, Valeriia Orlenko, Nataliia Pashkovska, Nataliia Pertseva, Olena Petrosyan, Ivan Smirnov, Maryna Vlasenko, Tetiana Zlova, Myint Aye, Arun Baksi, Mathangi Balasubramani, Ronnie Beboso, Mark Blagden, Charles Bundy, Tobias Cookson, Allan Copland, Alistair Emslie-Smith, Fiona Green, Anthony Gunstone, Basil Issa, Ewart Jackson-Voyzey, Andrew Johnson, Malcolm Maclean, John McKnight, Solomon Muzulu, Ian O'Connell, Babatunde Oyesile, Catherine Patterson, Ewan Pearson, Sam Philip, Paul Smith, Usha Sukumaran, Jalal Abbas, Gaurav Aggarwala, Faiq Akhter, James Andersen, Moise Anglade, Georges Argoud, Mehrdad Ariani, Reswan Ashdji, Ladan Bakhtari, Subhash Banerjee, Andrew Bartlett, Howard Baum, Harold Bays, Richard Beasley, Renata Belfort de Aguiar, Sabrina Benjamin, Ravi Bhagwat, Anuj Bhargava, Bruce Bode, Christina Bratcher, Toby Briskin, Andrew Brockmyre, Raymond Broughton, Judith Brown, Madhusudan Budhraja, Kevin Cannon, Jewell Carr, Harold Cathcart, Arvind Cavale, Louis Chaykin, Deanna Cheung, Richard Childress, Allan Cohen, Jonathan Condit, Erin Cooksey, George Mitchell Cornett, Ira Dauber, William Davila, Luis De Armas, Julius Dean, Robert Detweiler, Ernesto Diaz, Michael Di Giovanna, Isaac Dor, Waymon Drummond, Donald Eagerton, John Earl, Charles Eaton, Howard Ellison, Neil Farris, Thomas Fiel, Anthony Firek, Brian First, Les Forgosh, William French, Winston Gandy, Ronald Garcia, Santosh Gill, Murray Gordon, Michael Guice, Siva Gummadi, Jonathan Hackenyos, Kristen Hairston, Lenita Hanson, Lindsay Harrison, Israel Hartman, John Heitner, Srini Hejeebu, Paul Hermany, Carlos Hernandez-Cassis, Horacio Hidalgo, Alexander Higgins, Hassan Ibrahim, Shahram Jacobs, David Johnson, Parag Joshi, Steven Kaster, Daniel Kellum, Christopher Kim, Ellen Kim, William Kirby, Albert Knouse, Steven Kulback, Mariananda Kumar, Tulsidas Kuruvanka, Ajay Labroo, William Lasswell, John Lentz, Thomas Lenzmeier, David Lewis, Zhaoping Li, Michael Lillestol, Raymond Little, Richard Lorraine, Cecilia McKeown-Biagas, Robert McNeill, Anand Mehta, Alan Miller, Joseph Moran, Emily Morawski, Venkatesh Nadar, Thomas O'Connor, Alberto Odio, Reginald Parker, Rajesh Patel, Lawrence Phillips, George Raad, Aref Rahman, Marina Raikhel, Ajit Raisinghani, Raj Rajan, Neda Rasouli, Frank Rauzi, Kathryn Rohr, Hal Roseman, Sergio Rovner, Fadi Saba, Richard Sachson, Alex Schabauer, Ricky Schneider, Timothy Schuchard, John Sensenbrenner, Yshay Shlesinger, Narendra Singh, Kanagaratnam Sivalingam, Larry Stonesifer, Daniel Storey, David Suh, Mohammed Tahir, Anjanette Tan, Marilyn Tan, Alain Taylon, Maitreya Thakkar, Devjit Tripathy, Gabriel Uwaifo, Amarnath Vedere, Chandra Venugopal, Anthony Vo, Michelle Welch, James Welker, Alexander White, John Willis, Alan Wynne, Shahram Yazdani, Anne Rosenberg, Lauren Price, Kristina Sigmon, Yuliya Lokhngina, Weibing Xing, Robert Overton, Murray Stewart, Janet Stead, Alistair Lindsay, Vickas Patel, Jorge Ross, Joseph Soffer, Shruti Daga, Margaret Sowell, Prashant Patel, Louisa Garvey, Jessica Ackert, Sybil Abraham, Mary Beth Sabol, Desma Altobelli, JuYoung Ha, Mangesh Kulkarni, Matthew Somerville, Drusilla Noronha, Ed Casson, Eddie Zang, Chamandeep Sandhu, Rakesh Kumar, David Chen, Lin Taft, Rajivkumar Patel, June Ye, Jennifer Shannon, Tim Wilson, Charleen Babi, Diane Miller, Karl Thorpe, Rachael Russell, Georgina Bull, Belinda Hereghty, Eva Fernandez-Salazar, Troy Longley, Jill Donaldson, Marie Jarosz, Karen Murphy, Patricia Adams, Peter Smith, Rachel James, Jackie Richards, Sangeeta Sedani, Denise Althouse, David Watson, Jamie Lorimer, Steven Lauder, Ron Schultheis, Terese Womer, Ella Wraight, Wenyan Li, Emma Price-Olsen, Anthony Watson, Aoife Kelly, Patricia McLaughlin, John Fleming, Jessica Schubert, Debra Schleiden, Tara Harris, Rahul Prakash, Jody Breneman, Sameer Deshpande, Aarti Saswadkar, Aditi Kumari, Aditi Shitut, Amruta Raorane, Anisha Karmalkar, Ankita Mhambrey, Archana Bhosale, Ashok Vaphare, Ashwini P Patil, Chaitali Khandelwal, Fayaz Shaik, Madhumitha Nadar, Mounika Karka, Neha Kadgaonkar, Nikita Gupta, Nutan Aher, Omkar Potnis, Pallavi Naicker, Rakesh Shinde, Richa Sharma, Rupali Godse, Sheetal Solanki, Shruti Sahu, Snehal Dumbre, Somesh Kumar, Suradnya Patil, Trisha Mandal, Hernandez, Adrian F, Green, Jennifer B, Janmohamed, Salim, D'Agostino, Ralph B, Granger, Christopher B, Jones, Nigel P, Leiter, Lawrence A, Rosenberg, Anne E, Sigmon, Kristina N, Somerville, Matthew C, Thorpe, Karl M, Mcmurray, John J V, Del Prato, Stefano, Mcmurray, John J. V., D'Agostino, Ralph B., Granger, Christopher B., Hernandez, Adrian F., Leiter, Lawrence A., Califf, Robert M, Holman, Rury, Demets, David, Riddle, Matthew, Goodman, Shaun, Mcguire, Darren, Alexander, Karen, Devore, Adam, Melloni, Chiara, Patel, Chetan, Kong, David, Bloomfield, Gerald, Roe, Matthew, Tricoci, Pierluigi, Harrison, Rob, Lopes, Renato, Mathews, Robin, Mehta, Rajendra, Schuyler Jones, William, Vemulapalli, Sreekanth, Povsic, Thoma, Eapen, Zubin, Dombrowski, Keith, Kolls, Brad, Jordan, Dedrick, Ambrosy, Andrew, Greene, Stephen, Mandawat, Aditya, Shavadia, Jay, Cooper, Lauren, Sharma, Abhinav, Guimaraes, Patricia, Friedman, Daniel, Wilson, Matt, Endsley, Patricia, Gentry, Tracy, Collier, Jeannie, Perez, Kathleen, James, Kourtnei, Roush, Jennifer, Pope, Connie, Howell, Christina, Johnson, Megan, Bailey, Matt, Cole, Joanna, Akers, Teresa, Vandyne, Beth, Thomas, Betsy, Rich, Jenny, Bartone, Susan, Beaulieu, Gail, Brown, Kim, Chau, Tuan, Christian, Tamra, Coker, Rebecca, Greene, Deb, Haddock, Trevorlyn, Jenkins, Wendy, Haque, Ghazala, Marquess, Marsha, Pesarchick, Jean, Rethaford, Renee, Stone, Allegra, Al Kawas, Fira, Anderson, Michelle, Enns, Robert, Sinay, Isaac, Mathieu, Chantal, Yordanov, Victor, Hramiak, Irene, Haluzik, Martin, Galatius, Søren, Guerci, Bruno, Nauck, Michael, Migdalis, Ilia, Tan, Choon Beng Kathryn, Kocsis, Gyozo, Giaccari, Andrea, Lee, Moon Kyu, Muñoz, Ernesto German Cardona, Cornel, Jan, Birkeland, Kare, Pinto, Miguel, Tirador, Louie, Olesinska-Mader, Martyna, Shestakova, Marina, Distiller, Larry, Lopez-Sendon, Jose, Eliasson, Bjorn, Chiang, Chern-En, Srimahachota, Suphot, Mankovsky, Bori, Bethel, M Angelyn, Dungan, Kathleen, Kosiborod, Mikhail, Alvarisqueta, Andre, Baldovino, Jorge, Besada, Diego, Calella, Pedro, Cantero, Maria Cecilia, Castaño, Patricia, Chertkoff, Alejandro, Cuadrado, Jesu, De Loredo, Lui, Dominguez, Andrea, Español, Maria Vanesa, Finkelstein, Hernan, Frechtel, Gustavo, Fretes, Jose, Garrido Santos, Natalia, Gonzalez, Joaquin, Litvak, Marco, Loureyro, Juan, Maffei, Laura, Maldonado, Natacha, Mohr Gasparini, Diego, Orio, Silvia, Perez Manghi, Federico, Rodriguez Papini, Nelson, Sala, Jorgelina, Schygiel, Pablo, Sposetti, Georgina, Ulla, Maria, Verra, Fernando, Zabalua, Silvina, Zaidman, Cesar, Crenier, Laurent, Debroye, Corinne, Duyck, Franci, Scheen, André, Van Gaal, Luc, Vercammen, Chri, Damyanova, Velichka, Dimitrov, Stefan, Kovacheva, Snezhina, Lozanov, Lachezar, Margaritov, Viktor, Mihaylova-Shumkova, Rositsa, Nikolaeva, Antoaneta, Stoyanova, Zhasmina, Akhras, Ronald, Beaudry, Yve, Bedard, Jacque, Berlingieri, Joseph, Chehayeb, Raja, Cheung, Stephen, Conway, Jame, Cusson, Jean, Della Siega, Anthony, Dumas, Richard, Dzongowski, Peter, Ferguson, Murdo, Gaudet, Daniel, Grondin, Francoi, Gupta, Anil, Gupta, Milan, Halperin, Frank, Houle, Pierre-Alain, Jones, Michael, Kouz, Simon, Kovacs, Christopher, Landry, Daniel, Lonn, Eva, O'Mahony, William, Peterson, Sean, Reich, Denni, Rosenbloom, Alan, St-Maurice, Francoi, Tugwell, Barna, Vizel, Saul, Woo, Vincent, Brychta, Toma, Cech, Vladimir, Dvorakova, Eva, Edelsberger, Toma, Halciakova, Katarina, Krizova, Jarmila, Lastuvka, Jiri, Piperek, Martin, Prymkova, Vera, Raclavska, Lea, Silhova, Elena, Urbanek, Robin, Vrkoc, Jan, Andersen, Ulla, Brønnum-Schou, Jen, Hove, Jen, Jensen, Jan Skov, Kober, Lar, Kristiansen, Ole Peter, Lund, Per, Melchior, Thoma, Nyvad, Ole, Schou, Morten, Boye, Alain, Cadinot, Didier, Gouet, Didier, Henry, Patrick, Kessler, Laurence, Lalau, Jean-Daniel, Petit, Catherine, Thuan, Jean-Francoi, Voinot, Christel, Vouillarmet, Julien, Axthelm, Christoph, Berger, Dirk, Bieler, Tasso, Birkenfeld, Andrea, Bott, Jochen, Busch, Klau, Caca, Karel, Chevts, Julia, Donaubauer, Torsten, Erlinger, Rudolf, Funke, Klau, Grosskopf, Josef, Hagenow, Andrea, Hamann, Monika, Hartard, Manfred, Heymer, Peter, Huppertz, Wolfgang, Illies, Gabriele, Jacob, Stephan, Jung, Thoma, Kahrmann, Gerd, Kast, Petra, Kellerer, Monika, Kempe, Hans-Peter, Khariouzov, Andrei, Klausmann, Gerhard, Klein, Christiane, Kleinecke-Pohl, Uwe, Kleinertz, Klau, Koch, Thorsten, Kosch, Christine, Lorra, Babette, Luedemann, Joerg, Luttermann, Matthia, Maxeiner, Stephan, Milek, Karsten, Moelle, Andrea, Neumann, Gerhard, Nischik, Ruth, Oehrig-Pohl, Edith, Plassmann, Georg, Pohlmeier, Lar, Proepper, Felix, Regner, Stefan, Rieker, Werner, Rose, Ludger, Samer, Holger, Sauter, Joachim, Schaper, Frank, Schiffer, Clemen, Schmidt, Juergen, Scholz, Bernd-M., Schulze, Joerg, Segner, Alexander, Seufert, Jochen, Sigal, Helena, Steindorf, Joerg, Stockhausen, Juergen, Stuebler, Petra, Taeschner, Heidrun, Tews, Dietrich, Tschoepe, Diethelm, Wilhelm, Karl, Zeller-Stefan, Helga, Avramidis, Iakovo, Bousboulas, Stavro, Bristianou, Magdalini, Dimitriadis, Georgio, Elisaf, Mose, Kotsa, Kalliopi, Melidonis, Andrea, Mitrakou, Asimina, Pagkalos, Emmanouil, Papanas, Nikolao, Pappas, Angelo, Sampanis, Christo, Tentolouris, Nikolao, Tsapas, Apostolo, Tzatzagou, Glykeria, Ozaki, Risa, Hajdú, Csaba, Harcsa, Eleonóra, Konyves, Laszlo, Mucsi, Jáno, Pauker, Zsolt, Petró, Gizella, Plés, Zsolt, Revesz, Katalin, Sándor, Vangel, Vass, Viktor, Avogaro, Angelo, Boemi, Massimo, Bonadonna, Riccardo, Consoli, Agostino, De Cosmo, Salvatore, Di Bartolo, Paolo, Dotta, Francesco, Frontoni, Simona, Galetta, Marianna, Gambineri, Alessandra, Gazzaruso, Carmine, Giorgino, Francesco, Lauro, Davide, Orsi, Emanuela, Paolisso, Giuseppe, Perriello, Gabriele, Piatti, Piermarco, Pontiroli, Antonio, Ponzani, Paola, Rivellese, Angela Albarosa, Sesti, Giorgio, Tonolo, Giancarlo, Trevisan, Roberto, Ahn, Chul Woo, Baik, Sei-Hyun, Cha, Bong-Soo, Chung, Choon-Hee, Jang, Hak Chul, Kim, Chong-Jin, Kim, Hye Soon, Kim, In Joo, Lee, Eun Young, Lee, Hyoung Woo, Lee, Kwan-Woo, Moon, Keon-Woong, Namgung, June, Park, Kyong Soo, Yoo, Soon Jib, Yu, Jaemyung, Llamas, Edmundo-Alfredo Bayram, Cervantes-Escárcega, Jose-Lui, Flota-Cervera, Luis Fernando, González-González, José Gerardo, Pascoe-Gonzalez, Sara, Pelayo-Orozco, Emilia Susana, Ramirez-Diaz, Santiago-Paulino, Saldana-Mendoza, Arturo, Jerjes-Díaz, Carlos Sánchez, Torres-Colores, Jose Juan, Vidrio-Velázquez, Maricela, Villagordoa-Mesa, Juan, Beijerbacht, Hugo Peter, Groutars, Reginald G. E. J., Hoek, Boudewijn A, Hoogslag, Pieter A. M., Kooy, Adriaan, Kragten, Johannes A., Lieverse, Aloysius G., Swart, Hendrik P., Viergever, Eric P., Ahlqvist, Jørn, Cooper, John, Gulseth, Hanne, Guttormsen, Gaute, Wium, Cecilie, Arbañil, Hugo, Calderon, Jorge, Camacho, Lui, Espinoza, Augusto Dextre, Garrido, Elizabeth, Luna, Alejandro, Manrique, Helard, Revoredo, Frederick Massucco, Gonzales, Rolando Varga, Rincon, Luis Zapata, Zubiate, Carlo, Ebo, Geraldine, Morales-Palomares, Ellen, Arciszewska, Malgorzata, Banach, Marek, Bijata-Bronisz, Renata, Derezinski, Tadeusz, Gadzinski, Waldemar, Gajek, Jacek, Klodawska, Katarzyna, Krzyzagorska, Ewa, Madej, Andrzej, Miekus, Pawel, Opiela, Jaroslaw, Romanczuk, Piotr, Siegel, Anna, Skokowska, Ewa, Stankiewicz, Andrzej, Stasinska, Teresa, Trznadel-Morawska, Iwona, Witek, Robert, Aksentyev, Sergey, Bondar, Irina, Demidova, Irina, Dreval, Alexander, Ershova, Olga, Galstyan, Gagik, Garganeeva, Alla, Izmozherova, Nadezhda, Karetnikova, Victoria, Kharakhulakh, Marina, Khokhlov, Aleksandr, Kobalava, Zhanna, Koshelskaya, Olga, Kosmacheva, Elena, Kostin, Vladimir, Koziolova, Natalia, Kuzin, Anatoly, Lesnov, Victor, Lysenko, Tatyana, Markov, Valentin, Mayorov, Alexander, Moiseev, Sergey, Myasoedova, Svetlana, Petunina, Nina, Rebrov, Andrey, Ruyatkina, Ludmila, Samoylova, Julia, Sazonova, Olga, Shilkina, Natalia, Sokolova, Nadezhda, Vasilevskaya, Olga, Verbovaya, Nelli, Vishneva, Elena, Vorobyev, Sergey, Vorokhobina, Natalya, Zanozina, Olga, Zhdanova, Elena, Zykova, Tatyana, Burgess, Lesley, Coetzee, Kathleen, Dawood, Saleem, Lombard, Landman, Makotoko, Ellen, Moodley, Rajendran, Oosthuysen, Wessel, Sarvan, Mohamed, Calvo Gómez, Carlo, Cano Rodríguez, Isidoro, Castro Conde, Almudena, Cequier Fillat, Angel, Cuatrecasas Cambra, Guillem, de Álvaro Moreno, Fernando, De Teresa Parreño, Lui, Delgado Lista, Javier, Domínguez Escribano, José Ramón, Durán García, Santiago, Elvira González, Javier, Fernández Rodríguez, José María, Goday Arno, Alberto, Gomez Huelgas, Ricardo, González 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B., Altobelli, D., Ha, J., Kulkarni, M., Noronha, D., Casson, E., Zang, E., Sandhu, C., Kumar, R., Chen, D., Taft, L., Ye, J., Shannon, J., Wilson, T., Babi, C., Miller, D., Russell, R., Bull, G., Hereghty, B., Fernandez-Salazar, E., Longley, T., Donaldson, J., Jarosz, M., Murphy, K., Adams, P., James, R., Richards, J., Sedani, S., Althouse, D., Watson, D., Lorimer, J., Lauder, S., Schultheis, R., Womer, T., Wraight, E., Li, W., Price-Olsen, E., Watson, A., Kelly, A., Mclaughlin, P., Fleming, J., Schubert, J., Schleiden, D., Harris, T., Prakash, R., Breneman, J., Deshpande, S., Saswadkar, A., Kumari, A., Shitut, A., Raorane, A., Karmalkar, A., Mhambrey, A., Bhosale, A., Vaphare, A., Patil, A. P., Khandelwal, C., Shaik, F., Nadar, M., Karka, M., Kadgaonkar, N., Gupta, N., Aher, N., Potnis, O., Naicker, P., Shinde, R., Sharma, R., Godse, R., Solanki, S., Sahu, S., Dumbre, S., Kumar, S., Patil, S., Mandal, T., Skin function and permeability, Dermatology, Hernandez, A, Green, J, Janmohamed, S, D'Agostino, R, Granger, C, Jones, N, Leiter, L, Rosenberg, A, Sigmon, K, Somerville, M, Thorpe, K, Mcmurray, J, Del Prato, S, Califf, R, Holman, R, Demets, D, Riddle, M, Goodman, S, Mcguire, D, Alexander, K, Devore, A, Melloni, C, Patel, C, Kong, D, Bloomfield, G, Roe, M, Tricoci, P, Harrison, R, Lopes, R, Mathews, R, Mehta, R, Schuyler Jones, W, Vemulapalli, S, Povsic, T, Eapen, Z, Dombrowski, K, Kolls, B, Jordan, D, Ambrosy, A, Greene, S, Mandawat, A, Shavadia, J, Cooper, L, Sharma, A, Guimaraes, P, Friedman, D, Wilson, M, Endsley, P, Gentry, T, Collier, J, Perez, K, James, K, Roush, J, Pope, C, Howell, C, Johnson, M, Bailey, M, Cole, J, Akers, T, Vandyne, B, Thomas, B, Rich, J, Bartone, S, Beaulieu, G, Brown, K, Chau, T, Christian, T, Coker, R, Greene, D, Haddock, T, Jenkins, W, Haque, G, Marquess, M, Pesarchick, J, Rethaford, R, Stone, A, Al Kawas, F, Anderson, M, Enns, R, Sinay, I, Mathieu, C, Yordanov, V, Hramiak, I, Haluzik, M, Galatius, S, Guerci, B, Nauck, M, Migdalis, I, Tan, C, Kocsis, G, Giaccari, A, Lee, M, Munoz, E, Cornel, J, Birkeland, K, Pinto, M, Tirador, L, Olesinska-Mader, M, Shestakova, M, Distiller, L, Lopez-Sendon, J, Eliasson, B, Chiang, C, Srimahachota, S, Mankovsky, B, Bethel, M, Dungan, K, Kosiborod, M, Alvarisqueta, A, Baldovino, J, Besada, D, Calella, P, Cantero, M, Castano, P, Chertkoff, A, Cuadrado, J, De Loredo, L, Dominguez, A, Espanol, M, Finkelstein, H, Frechtel, G, Fretes, J, Garrido Santos, N, Gonzalez, J, Litvak, M, Loureyro, J, Maffei, L, Maldonado, N, Mohr Gasparini, D, Orio, S, Perez Manghi, F, Rodriguez Papini, N, Sala, J, Schygiel, P, Sposetti, G, Ulla, M, Verra, F, Zabalua, S, Zaidman, C, Crenier, L, Debroye, C, Duyck, F, Scheen, A, Van Gaal, L, Vercammen, C, Damyanova, V, Dimitrov, S, Kovacheva, S, Lozanov, L, Margaritov, V, Mihaylova-Shumkova, R, Nikolaeva, A, Stoyanova, Z, Akhras, R, Beaudry, Y, Bedard, J, Berlingieri, J, Chehayeb, R, Cheung, S, Conway, J, Cusson, J, Della Siega, A, Dumas, R, Dzongowski, P, Ferguson, M, Gaudet, D, Grondin, F, Gupta, A, Gupta, M, Halperin, F, Houle, P, Jones, M, Kouz, S, Kovacs, C, Landry, D, Lonn, E, O'Mahony, W, Peterson, S, Reich, D, Rosenbloom, A, St-Maurice, F, Tugwell, B, Vizel, S, Woo, V, Brychta, T, Cech, V, Dvorakova, E, Edelsberger, T, Halciakova, K, Krizova, J, Lastuvka, J, Piperek, M, Prymkova, V, Raclavska, L, Silhova, E, Urbanek, R, Vrkoc, J, Andersen, U, Bronnum-Schou, J, Hove, J, Jensen, J, Kober, L, Kristiansen, O, Lund, P, Melchior, T, Nyvad, O, Schou, M, Boye, A, Cadinot, D, Gouet, D, Henry, P, Kessler, L, Lalau, J, Petit, C, Thuan, J, Voinot, C, Vouillarmet, J, Axthelm, C, Berger, D, Bieler, T, Birkenfeld, A, Bott, J, Busch, K, Caca, K, Chevts, J, Donaubauer, T, Erlinger, R, Funke, K, Grosskopf, J, Hagenow, A, Hamann, M, Hartard, M, Heymer, P, Huppertz, W, Illies, G, Jacob, S, Jung, T, Kahrmann, G, Kast, P, Kellerer, M, Kempe, H, Khariouzov, A, Klausmann, G, Klein, C, Kleinecke-Pohl, U, Kleinertz, K, Koch, T, Kosch, C, Lorra, B, Luedemann, J, Luttermann, M, Maxeiner, S, Milek, K, Moelle, A, Neumann, G, Nischik, R, Oehrig-Pohl, E, Plassmann, G, Pohlmeier, L, Proepper, F, Regner, S, Rieker, W, Rose, L, Samer, H, Sauter, J, Schaper, F, Schiffer, C, Schmidt, J, Scholz, B, Schulze, J, Segner, A, Seufert, J, Sigal, H, Steindorf, J, Stockhausen, J, Stuebler, P, Taeschner, H, Tews, D, Tschoepe, D, Wilhelm, K, Zeller-Stefan, H, Avramidis, I, Bousboulas, S, Bristianou, M, Dimitriadis, G, Elisaf, M, Kotsa, K, Melidonis, A, Mitrakou, A, Pagkalos, E, Papanas, N, Pappas, A, Sampanis, C, Tentolouris, N, Tsapas, A, Tzatzagou, G, Ozaki, R, Hajdu, C, Harcsa, E, Konyves, L, Mucsi, J, Pauker, Z, Petro, G, Ples, Z, Revesz, K, Sandor, V, Vass, V, Avogaro, A, Boemi, M, Bonadonna, R, Consoli, A, De Cosmo, S, Di Bartolo, P, Dotta, F, Frontoni, S, Galetta, M, Gambineri, A, Gazzaruso, C, Giorgino, F, Lauro, D, Orsi, E, Paolisso, G, Perriello, G, Piatti, P, Pontiroli, A, Ponzani, P, Rivellese, A, Sesti, G, Tonolo, G, Trevisan, R, Ahn, C, Baik, S, Cha, B, Chung, C, Jang, H, Kim, C, Kim, H, Kim, I, Lee, E, Lee, H, Lee, K, Moon, K, Namgung, J, Park, K, Yoo, S, Yu, J, Llamas, E, Cervantes-Escarcega, J, Flota-Cervera, L, Gonzalez-Gonzalez, J, Pascoe-Gonzalez, S, Pelayo-Orozco, E, Ramirez-Diaz, S, Saldana-Mendoza, A, Jerjes-Diaz, C, Torres-Colores, J, Vidrio-Velazquez, M, Villagordoa-Mesa, J, Beijerbacht, H, Groutars, R, Hoek, B, Hoogslag, P, Kooy, A, Kragten, J, Lieverse, A, Swart, H, Viergever, E, Ahlqvist, J, Cooper, J, Gulseth, H, Guttormsen, G, Wium, C, Arbanil, H, Calderon, J, Camacho, L, Espinoza, A, Garrido, E, Luna, A, Manrique, H, Revoredo, F, Gonzales, R, Rincon, L, Zubiate, C, Ebo, G, Morales-Palomares, E, Arciszewska, M, Banach, M, Bijata-Bronisz, R, Derezinski, T, Gadzinski, W, Gajek, J, Klodawska, K, Krzyzagorska, E, Madej, A, Miekus, P, Opiela, J, Romanczuk, P, Siegel, A, Skokowska, E, Stankiewicz, A, Stasinska, T, Trznadel-Morawska, I, Witek, R, Aksentyev, S, Bondar, I, Demidova, I, Dreval, A, Ershova, O, Galstyan, G, Garganeeva, A, Izmozherova, N, Karetnikova, V, Kharakhulakh, M, Khokhlov, A, Kobalava, Z, Koshelskaya, O, Kosmacheva, E, Kostin, V, Koziolova, N, Kuzin, A, Lesnov, V, Lysenko, T, Markov, V, Mayorov, A, Moiseev, S, Myasoedova, S, Petunina, N, Rebrov, A, Ruyatkina, L, Samoylova, J, Sazonova, O, Shilkina, N, Sokolova, N, Vasilevskaya, O, Verbovaya, N, Vishneva, E, Vorobyev, S, Vorokhobina, N, Zanozina, O, Zhdanova, E, Zykova, T, Burgess, L, Coetzee, K, Dawood, S, Lombard, L, Makotoko, E, Moodley, R, Oosthuysen, W, Sarvan, M, Calvo Gomez, C, Cano Rodriguez, I, Castro Conde, A, Cequier Fillat, A, Cuatrecasas Cambra, G, de Alvaro Moreno, F, De Teresa Parreno, L, Delgado Lista, J, Dominguez Escribano, J, Duran Garcia, S, Elvira Gonzalez, J, Fernandez Rodriguez, J, Goday Arno, A, Gomez Huelgas, R, Gonzalez Juanatey, J, Hernandez Mijares, A, Jimenez Diaz, V, Jodar Gimeno, E, Lucas Morante, T, Marazuela, M, Martell Claros, N, Mauricio Puente, D, Mena Ribas, E, Merino Torres, J, Mezquita Raya, P, Nubiola Calonge, A, Ordonez Sanchez, X, Pascual Izuel, J, Perea Castilla, V, Perez Perez, A, Perez Soto, I, Quesada Charneco, M, Quesada Simon, A, Redon Mas, J, Rego Iraeta, A, Rodriguez Alvarez, M, Rodriguez Rodriguez, I, Saban Ruiz, J, Soto Gonzalez, A, Tinahones Madueno, F, Trescoli Serrano, C, Ulied Arminana, A, Bachus, E, Berndtsson Blom, K, Eliasson, K, Koskinen, P, Larnefeldt, H, Lif-Tiberg, C, Linderfalk, C, Lund, G, Lundman, P, Moris, L, Olsson, A, Salmonsson, S, Sanmartin Berglund, J, Sjoberg, F, Soderberg, S, Torstensson, I, Chen, J, Tien, K, Tseng, S, Tu, S, Wang, C, Wang, J, Phrommintikul, A, Yamwong, S, Jintapakorn, W, Hutayanon, P, Sansanayudh, N, Bazhan, L, Fushtey, I, Grachova, M, Katerenchuk, V, Korpachev, V, Kravchun, N, Larin, O, Mykhalchyshyn, G, Myshanych, H, Oleksyk, O, Orlenko, V, Pashkovska, N, Pertseva, N, Petrosyan, O, Smirnov, I, Vlasenko, M, Zlova, T, Aye, M, Baksi, A, Balasubramani, M, Beboso, R, Blagden, M, Bundy, C, Cookson, T, Copland, A, Emslie-Smith, A, Green, F, Gunstone, A, Issa, B, Jackson-Voyzey, E, Johnson, A, Maclean, M, Mcknight, J, Muzulu, S, O'Connell, I, Oyesile, B, Patterson, C, Pearson, E, Philip, S, Smith, P, Sukumaran, U, Abbas, J, Aggarwala, G, Akhter, F, Andersen, J, Anglade, M, Argoud, G, Ariani, M, Ashdji, R, Bakhtari, L, Banerjee, S, Bartlett, A, Baum, H, Bays, H, Beasley, R, Belfort de Aguiar, R, Benjamin, S, Bhagwat, R, Bhargava, A, Bode, B, Bratcher, C, Briskin, T, Brockmyre, A, Broughton, R, Brown, J, Budhraja, M, Cannon, K, Carr, J, Cathcart, H, Cavale, A, Chaykin, L, Cheung, D, Childress, R, Cohen, A, Condit, J, Cooksey, E, Cornett, G, Dauber, I, Davila, W, De Armas, L, Dean, J, Detweiler, R, Diaz, E, Di Giovanna, M, Dor, I, Drummond, W, Eagerton, D, Earl, J, Eaton, C, Ellison, H, Farris, N, Fiel, T, Firek, A, First, B, Forgosh, L, French, W, Gandy, W, Garcia, R, Gill, S, Gordon, M, Guice, M, Gummadi, S, Hackenyos, J, Hairston, K, Hanson, L, Harrison, L, Hartman, I, Heitner, J, Hejeebu, S, Hermany, P, Hernandez-Cassis, C, Hidalgo, H, Higgins, A, Ibrahim, H, Jacobs, S, Johnson, D, Joshi, P, Kaster, S, Kellum, D, Kim, E, Kirby, W, Knouse, A, Kulback, S, Kumar, M, Kuruvanka, T, Labroo, A, Lasswell, W, Lentz, J, Lenzmeier, T, Lewis, D, Li, Z, Lillestol, M, Little, R, Lorraine, R, McKeown-Biagas, C, Mcneill, R, Mehta, A, Miller, A, Moran, J, Morawski, E, Nadar, V, O'Connor, T, Odio, A, Parker, R, Patel, R, Phillips, L, Raad, G, Rahman, A, Raikhel, M, Raisinghani, A, Rajan, R, Rasouli, N, Rauzi, F, Rohr, K, Roseman, H, Rovner, S, Saba, F, Sachson, R, Schabauer, A, Schneider, R, Schuchard, T, Sensenbrenner, J, Shlesinger, Y, Singh, N, Sivalingam, K, Stonesifer, L, Storey, D, Suh, D, Tahir, M, Tan, A, Tan, M, Taylon, A, Thakkar, M, Tripathy, D, Uwaifo, G, Vedere, A, Venugopal, C, Vo, A, Welch, M, Welker, J, White, A, Willis, J, Wynne, A, Yazdani, S, Price, L, Lokhngina, Y, Xing, W, Overton, R, Stewart, M, Stead, J, Lindsay, A, Patel, V, Ross, J, Soffer, J, Daga, S, Sowell, M, Patel, P, Garvey, L, Ackert, J, Abraham, S, Sabol, M, Altobelli, D, Ha, J, Kulkarni, M, Noronha, D, Casson, E, Zang, E, Sandhu, C, Kumar, R, Chen, D, Taft, L, Ye, J, Shannon, J, Wilson, T, Babi, C, Miller, D, Russell, R, Bull, G, Hereghty, B, Fernandez-Salazar, E, Longley, T, Donaldson, J, Jarosz, M, Murphy, K, Adams, P, James, R, Richards, J, Sedani, S, Althouse, D, Watson, D, Lorimer, J, Lauder, S, Schultheis, R, Womer, T, Wraight, E, Li, W, Price-Olsen, E, Watson, A, Kelly, A, Mclaughlin, P, Fleming, J, Schubert, J, Schleiden, D, Harris, T, Prakash, R, Breneman, J, Deshpande, S, Saswadkar, A, Kumari, A, Shitut, A, Raorane, A, Karmalkar, A, Mhambrey, A, Bhosale, A, Vaphare, A, Patil, A, Khandelwal, C, Shaik, F, Nadar, M, Karka, M, Kadgaonkar, N, Gupta, N, Aher, N, Potnis, O, Naicker, P, Shinde, R, Sharma, R, Godse, R, Solanki, S, Sahu, S, Dumbre, S, Kumar, S, Patil, S, and Mandal, T
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Male ,Placebo-controlled study ,Myocardial Infarction ,alanine aminotransferase, albiglutide, bilirubin, placebo, antidiabetic agent, glucagon like peptide 1, rGLP-1 protein ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Glucagon-Like Peptide 1 ,Cardiovascular Disease ,Medicine(all) ,education.field_of_study ,Subcutaneous ,Medicine (all) ,albigutide ,Hazard ratio ,General Medicine ,Middle Aged ,Albiglutide ,Stroke ,Treatment Outcome ,Tolerability ,Cardiovascular Diseases ,Female ,type 2 diabetes ,Type 2 ,Human ,Adult ,medicine.medical_specialty ,Injections, Subcutaneous ,Population ,030209 endocrinology & metabolism ,Placebo ,Injections, Subcutaneou ,Drug Administration Schedule ,Injections ,03 medical and health sciences ,Double-Blind Method ,Internal medicine ,Diabetes Mellitus ,medicine ,Humans ,Hypoglycemic Agents ,education ,Aged ,Diabetes Mellitus, Type 2 ,Hypoglycemic Agent ,business.industry ,Semaglutide ,Settore MED/13 - ENDOCRINOLOGIA ,Harmony ,business - Abstract
Background: \ud Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke.\ud \ud Methods: \ud We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515.\ud \ud Findings: \ud Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p
- Published
- 2018
21. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial
- Author
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Paresh Dandona, Chantal Mathieu, Moshe Phillip, Lars Hansen, Steven C Griffen, Diethelm Tschöpe, Fredrik Thorén, John Xu, Anna Maria Langkilde, Joseph Proietto, Stephen Stranks, Roger Chen, David O'Neal, Alexia Pape, Mark Forbes, Claire Morbey, Anton Luger, Ursula Hanusch, Christoph Schnack, Evelyn Fliesser-Goerzer, Bertram Hoelzl, Christoph Ebenbichler, Rudolf Prager, Luc Van Gaal, Chris Vercammen, Andre Scheen, Francis Duyck, Frank Nobels, Johannes Ruige, Naresh Aggarwal, Vincent Woo, Bruno St-Pierre, Richard Dumas, Irene Hramiak, Thomas Elliott, Troels Krarup Hansen, Jan Erik Henriksen, Jeppe Gram, Aina Lihn, Jens Bruun, Juha Saltevo, Jyrki Taurio, Jorma Strand, Timo Valle, Sakari Nieminen, Kirsi Pietilainen, Bruno Guerci, Samy Hadjadj, Bertrand Cariou, Bruno Verges, Sophie Borot, Alfred Penfornis, Thomas Schaum, Diethelm Tschoepe, Cornelia Marck, Thomas Horacek, Ludger Rose, Gerhard Klausmann, Joerg Luedemann, Steffi Appelt, Ulrich Aigner, Rolf Goebel, Thomas Behnke, Anette-Gabriele Ziegler, Eva Peterfai, Zsuzsanna Kerenyi, Tamas Oroszlan, Gyula G. Kiss, Laszlo Konyves, Gyorgyi Piros, Ofri Mosenzon, Naim Shehadeh, Faiad Adawi, Julio Wainstein, Francesco Dotta, Piermarco Piatti, Stefano Genovese, Agostino Consoli, Paolo Di Bartolo, Edoardo Mannucci, Carla Giordano, Annunziata Lapolla, Carlos Aguilar, Alberto Esteban, Bazzoni Ruiz, Guillermo Mondragon Ramirez, Emilia Pelayo Orozco, Carlos Alejandro, Stobschinski de Alba, Carlos Medina Pech, Jose Garza Ruiz, Leobardo Sauque Reyna, Guillermo Llamas Esperon, Luis Alejandro Nevarez Ruiz, Maricela Vidrio Velazquez, Fernando Flores Lozano, Jose Gerardo Gonzalez Gonzalez, Pedro Alberto Garcia-Hernandez, Roberto Araujo-Silva, Efrain Villeda - Espinosa, Cristina Mistodie, Daniela Popescu, Ciprian Constantin, Alina Nicolau, Bogdan Popa, Romulus Timar, Cristian Serafinceanu, Ella Pintilei, Alfonso Soto, Margarita Gimenez, Juan Francisco Merino-Torres, Cristobal Morales, Pedro Mezquita, Johan Jendle, Bengt-Olov Tengmark, Jan Eriksson, Magnus Londahl, Bjorn Eliasson, Anthony Gunstone, Simon Heller, Ken Darzy, Peter Mansell, Melanie Davies, Rory Reed, Duncan Browne, Hamish Courtney, Wayne Turner, Mark Blagden, Rory McCrimmon, Richard Bergenstal, Wendy Lane, Kathryn Lucas, Alexander White, Shichun Bao, Judith White, Curtis Jantzi, Neda Rasouli, William Ervin, Lorena Lewy-Alterbaum, Yehuda Handelsman, Bresta Miranda-Palma, Alan Cleland, Raymond Fink, Helena Rodbard, Samer Nakhle, Craig Greenberg, Alan Schorr, Harold Bays, Debra Simmons, Eric Klein, Laurie Kane, Norman Fishman, Eli Ipp, Satish Garg, Anuj Bhargava, Michelle Zaniewski Singh, Julio Rosenstock, James Thrasher, Mark Warren, Laura Young, Vanita Aroda, Jeremy Pettus, David Liljenquist, Robert Busch, Jonathan Wise, David Kayne, William Biggs, Dandona P., Mathieu C., Phillip M., Hansen L., Griffen S.C., Tschope D., Thoren F., Xu J., Langkilde A.M., Proietto J., Stranks S., Chen R., O'Neal D., Pape A., Forbes M., Morbey C., Luger A., Hanusch U., Schnack C., Fliesser-Goerzer E., Hoelzl B., Ebenbichler C., Prager R., Van Gaal L., Vercammen C., Scheen A., Duyck F., Nobels F., Ruige J., Aggarwal N., Woo V., St-Pierre B., Dumas R., Hramiak I., Elliott T., Krarup Hansen T., Henriksen J.E., Gram J., Lihn A., Bruun J., Saltevo J., Taurio J., Strand J., Valle T., Nieminen S., Pietilainen K., Guerci B., Hadjadj S., Cariou B., Verges B., Borot S., Penfornis A., Schaum T., Tschoepe D., Marck C., Horacek T., Rose L., Klausmann G., Luedemann J., Appelt S., Aigner U., Goebel R., Behnke T., Ziegler A.-G., Peterfai E., Kerenyi Z., Oroszlan T., Kiss G.G., Konyves L., Piros G., Mosenzon O., Shehadeh N., Adawi F., Wainstein J., Dotta F., Piatti P., Genovese S., Consoli A., Di Bartolo P., Mannucci E., Giordano C., Lapolla A., Aguilar C., Esteban A., Ruiz B., Ramirez G.M., Pelayo Orozco E., Alejandro C., de Alba S., Medina Pech C., Garza Ruiz J., Sauque Reyna L., Llamas Esperon G., Nevarez Ruiz L.A., Vidrio Velazquez M., Flores Lozano F., Gonzalez Gonzalez J.G., Garcia-Hernandez P.A., Araujo-Silva R., Villeda - Espinosa E., Mistodie C., Popescu D., Constantin C., Nicolau A., Popa B., Timar R., Serafinceanu C., Pintilei E., Soto A., Gimenez M., Merino J., Morales C., Mezquita P., Jendle J., Tengmark B.-O., Eriksson J., Londahl M., Eliasson B., Gunstone A., Heller S., Darzy K., Mansell P., Davies M., Reed R., Browne D., Courtney H., Turner W., Blagden M., McCrimmon R., Bergenstal R., Lane W., Lucas K., White A., Bao S., White J., Jantzi C., Rasouli N., Ervin W., Lewy-Alterbaum L., Handelsman Y., Miranda-Palma B., Cleland A., Fink R., Rodbard H., Nakhle S., Greenberg C., Schorr A., Bays H., Simmons D., Klein E., Kane L., Fishman N., Ipp E., Garg S., Bhargava A., Singh M.Z., Rosenstock J., Thrasher J., Warren M., Young L., Aroda V., Pettus J., Liljenquist D., Busch R., Wise J., Kayne D., and Biggs W.
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Male ,Glycated Hemoglobin A ,Endocrinology, Diabetes and Metabolism ,Type 2 diabetes ,030204 cardiovascular system & hematology ,Settore MED/13 - Endocrinologia ,law.invention ,chemistry.chemical_compound ,0302 clinical medicine ,Endocrinology ,diabetes, dapaglifozin ,Glucosides ,Randomized controlled trial ,law ,Insulin ,03.02. Klinikai orvostan ,Dapagliflozin ,Middle Aged ,Diabetes and Metabolism ,Treatment Outcome ,Combination ,Drug Therapy, Combination ,Female ,Type 1 ,Adult ,medicine.medical_specialty ,Diabetic ketoacidosis ,030209 endocrinology & metabolism ,Placebo ,03 medical and health sciences ,Drug Therapy ,Diabetes management ,Diabetes mellitus ,Internal medicine ,Diabetes Mellitus ,Internal Medicine ,medicine ,Humans ,Hypoglycemic Agents ,Benzhydryl Compounds ,Body Weight ,Diabetes Mellitus, Type 1 ,Hypoglycemia ,Glycated Hemoglobin ,Type 1 diabetes ,business.industry ,medicine.disease ,Surgery ,chemistry ,business - Abstract
Background Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor approved for the treatment of type 2 diabetes. We aimed to assess the efficacy and safety of dapagliflozin as an add-on to adjustable insulin in patients with inadequately controlled type 1 diabetes. Methods DEPICT-1 was a double-blind, randomised, parallel-controlled, three-arm, phase 3, multicentre study done at 143 sites in 17 countries. Eligible patients were aged 18–75 years and had inadequately controlled type 1 diabetes (HbA1c between ≥7·7% and ≤11·0% [≥61·0 mmol/mol and ≤97·0 mmol/mol]) and had been prescribed insulin for at least 12 months before enrolment. After an 8 week lead-in period to optimise diabetes management, patients were randomly assigned (1:1:1) using an interactive voice response system to dapagliflozin 5 mg or 10 mg once daily, given orally, or matched placebo. Randomisation was stratified by current use of continuous glucose monitoring, method of insulin administration, and baseline HbA1c. The primary efficacy outcome was the change from baseline in HbA1c after 24 weeks of treatment in the full analysis set, which consisted of all randomly assigned patients who received at least one dose of study drug. An additional 55 patients who were incorrectly and non-randomly allocated to only dapagliflozin treatment groups were included in the safety analysis set. This study was registered with ClinicalTrials.gov, number NCT02268214; data collection for the present analysis was completed on Jan 4, 2017, and a 28 week extension phase is ongoing. Findings Between Nov 11, 2014, and April 16, 2016, 833 patients were assigned to treatment groups and included in safety analyses (dapagliflozin 5 mg [n=277] vs dapagliflozin 10 mg [n=296] vs placebo [n=260]; 778 of these patients were randomly assigned and included in the full analysis set for efficacy analyses (259 vs 259 vs 260; difference due to randomisation error affecting 55 patients). Mean baseline HbA1c was 8·53% (70 mmol/mol; SD 0·67% [7·3 mmol/mol]). At week 24, both doses of dapagliflozin significantly reduced HbA1c compared with placebo (mean difference from baseline to week 24 for dapagliflozin 5 mg vs placebo was −0·42% [95% CI −0·56 to −0·28; p
- Published
- 2017
22. Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial
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Hiddo J L Heerspink, Hans-Henrik Parving, Dennis L Andress, George Bakris, Ricardo Correa-Rotter, Fan-Fan Hou, Dalane W Kitzman, Donald Kohan, Hirofumi Makino, John J V McMurray, Joel Z Melnick, Michael G Miller, Pablo E Pergola, Vlado Perkovic, Sheldon Tobe, Tingting Yi, Melissa Wigderson, Dick de Zeeuw, Alicia Elbert, Augusto Vallejos, Andres Alvarisqueta, Laura Maffei, Luis Juncos, Javier de Arteaga, Gustavo Greloni, Eduardo Farias, Alfredo Zucchini, Daniel Vogel, Ana Cusumano, Juan Santos, Margaret Fraenkel, Martin Gallagher, Tim Davis, Shamasunder Acharya, Duncan Cooke, Michael Suranyi, Simon Roger, Nigel Toussaint, Carol Pollock, Doris Chan, Stephen Stranks, Richard MacIsaac, Zoltan Endre, Alice Schmidt, Rudolf Prager, Gert Mayer, Xavier Warling, Michel Jadoul, Jean Hougardy, Chris Vercammen, Bruno Van Vlem, Pieter Gillard, Adriana Costa e Forti, Joao Lindolfo Borges, Luis Santos Canani, Freddy Eliaschewitz, Silmara Leite, Fadlo Fraige Filho, Raphael Paschoalin, Jose Andrade Moura Neto, Luciane Deboni, Irene de Lourdes Noronha, Cintia Cercato, Carlos Alberto Prompt, Maria Zanella, Nelson Rassi, Domingos D'Avila, Rosangela Milagres, Joao Felicio, Roberto Pecoits Filho, Miguel Carlos Riella, Joao Salles, Elizete Keitel, Sergio Draibe, Celso Amodeo, Joseph Youmbissi, Louise Roy, Serge Cournoyer, Shivinder Jolly, Vincent Pichette, Gihad Nesrallah, Harpreet Singh Bajaj, Hasnain Khandwala, Ronnie Aronson, Richard Goluch, Paul Tam, Christian Rabbat, Gordon Bailey, Stephen Chow, Alvaro Castillo, Alfredo Danin Vargas, Fernando Gonzalez, Rodrigo Munoz, Vicente Gutierrez, Gonzalo Godoy, Hongwen Zhao, Zhangsuo Liu, Minghui Zhao, Xiaohui Guo, Benli Su, Shuxia Fu, Yan Xu, Jinkui Yang, Bingyin Shi, Guanqing Xiao, Wei Shi, Chuanming Hao, Changying Xing, Fanfan Hou, Qun Luo, Yuxiu Li, Linong Ji, Li Zuo, Song Wang, Zhaohui Ni, Guohua Ding, Nan Chen, Jiajun Zhao, Weiping Jia, Shengqiang Yu, Jian Weng, Gang Xu, Ping Fu, Shiren Sun, Bicheng Liu, Xiaoqiang Ding, Ivan Rychlik, Alexandra Oplustilova, Dagmar Bartaskova, Vaclava Honova, Hana Chmelickova, Martin Petr, Petr Bucek, Vladimir Tesar, Emil Zahumensky, Johan Povlsen, Kenneth Egstrup, Anna Oczachowska-Kulik, Peter Rossing, Jorma Lahtela, Jorma Strand, Ilkka Kantola, Catherine Petit, Christian Combe, Philippe Zaoui, Vincent Esnault, Pablo Urena Torres, Jean-Michel Halimi, Bertrand Dussol, Tasso Bieler, Klemens Budde, Frank Dellanna, Thomas Segiet, Christine Kosch, Hans Schmidt-Guertler, Isabelle Schenkenberger, Volker Vielhauer, Frank Pistrosch, Mark Alscher, Christoph Hasslacher, Christian Hugo, Anja Muehlfeld, Christoph Wanner, Ploumis Passadakis, Theofanis Apostolou, Nikolaos Tentolouris, Ioannis Stefanidis, Konstantinos Mavromatidis, Vasilios Liakopoulos, Dimitrios Goumenos, Konstantinos Siamopoulos, Vincent Yeung, Risa Ozaki, Samuel Fung, Kathryn Tan, Sydney Tang, Sing Leung Lui, Siu Fai Cheung, Seamus Sreenan, Joseph Eustace, Donal O'Shea, Peter Lavin, Austin Stack, Yoram Yagil, Julio Wainstein, Hilla Knobler, Josef Cohen, Irina Kenis, Deeb Daoud, Yosefa Bar-Dayan, Victor Frajewicki, Faiad Adawi, Loreto Gesualdo, Domenico Santoro, Francesco Marino, Andrea Galfre, Chiara Brunati, Piero Ruggenenti, Giuseppe Rombola, Giuseppe Pugliese, Maura Ravera, Fabio Malberti, Giuseppe Pontoriero, Teresa Rampino, Salvatore De Cosmo, Ciro Esposito, Felice Nappi, Cataldo Abaterusso, Giuseppe Conte, Vincenzo Panichi, Davide Lauro, Giovambattista Capasso, Domenico Russo, Jiichi Anzai, Motoji Naka, Keita Ato, Tetsuro Tsujimoto, Toshinori Nimura, Eitaro Nakashima, Tetsuro Takeda, Shinya Fujii, Kunihisa Kobayashi, Hideaki Iwaoka, Koji Nagayama, Hiroyuki Harada, Hajime Maeda, Rui Kishimoto, Tadashi Iitsuka, Naoki Itabashi, Ryuichi Furuya, Yoshitaka Maeda, Daishiro Yamada, Nobuhiro Sasaki, Hiromitsu Sasaki, Shinichiro Ueda, Naoki Kashihara, Shuichi Watanabe, Takehiro Nakamura, Hidetoshi Kanai, Yuichiro Makita, Keiko Ono, Noriyuki Iehara, Daisuke Goto, Keiichiro Kosuge, Kenichi Tsuchida, Toshiaki Sato, Takashi Sekikawa, Hideki Okamoto, Tsuyoshi Tanaka, Naoko Ikeda, Takenobu Tadika, Koji Mukasa, Takeshi Osonoi, Fuminori Hirano, Motonobu Nishimura, Yuko Yambe, Yukio Tanaka, Makoto Ujihara, Takashi Sakai, Mitsuo Imura, Yutaka Umayahara, Shinya Makino, Jun Nakazawa, Yukinari Yamaguchi, Susumu Kashine, Hiroaki Miyaoka, Katsunori Suzuki, Toshihiko Inoue, Sou Nagai, Nobuyuki Sato, Masahiro Yamamoto, Noriyasu Taya, Akira Fujita, Akira Matsutani, Yugo Shibagaki, Yuichi Sato, Akira Yamauchi, Masahiro Tsutsui, Tamayo Ishiko, Shizuka Kaneko, Nobuyuki Azuma, Hirofumi Matsuda, Yasuhiro Hashiguchi, Yukiko Onishi, Mikiya Tokui, Munehide Matsuhisa, Arihiro Kiyosue, Junji Shinoda, Kazuo Ishikawa, Ghazali Ahmad, Shalini Vijayasingham, Nor Azizah Aziz, Zanariah Hussein, Yin Khet Fung, Wan Hasnul Halimi Wan Hassan, Hin Seng Wong, Bak Leong Goh, Norhaliza Mohd Ali, Nor Shaffinaz Yusuf Azmi Merican, Indralingam Vaithilingam, Nik Nur Fatnoon Nik Ahmad, Noor Adam, Norlela Sukor, V Paranthaman P Vengadasalam, Khalid Abdul Kadir, Mafauzy Mohamed, Karina Renoirte Lopez, Aniceto Leguizamo-Dimas, Alfredo Chew Wong, Jose Chevaile-Ramos, Jose Gonzalez Gonzalez, Raul Rico Hernandez, Jose Nino-Cruz, Leobardo Sauque Reyna, Guillermo Gonzalez-Galvez, Magdalena Madero Rovalo, Tomasso Bochicchio-Ricardelli, Jorge Aldrete, Jaime Carranza-Madrigal, Liffert Vogt, Peter Smak Gregoor, JNM Barendregt, Peter Luik, Ronald Gansevoort, Gozewijn Laverman, Helen Pilmore, Helen Lunt, John Baker, Steven Miller, Kannaiyan Rabindranath, Luis Zapata-Rincon, Rolando Vargas-Gonzales, Jorge Calderon Ticona, Augusto Dextre Espinoza, Jose Burga Nunez, Carlos Antonio Zea-Nunez, Benjamin Herrada Orue, Boris Medina-Santander, Cesar Delgado-Butron, Julio Farfan-Aspilcueta, Stanislaw Mazur, Miroslaw Necki, Michal Wruk, Katarzyna Klodawska, Grazyna Popenda, Ewa Skokowska, Malgorzata Arciszewska, Andrzej Wiecek, Kazimierz Ciechanowski, Michal Nowicki, Rita Birne, Antonio Cabrita, Aura Ramos, Manuel Anibal Antunes Ferreira, Evelyn Matta Fontanet, Altagracia Aurora Alcantara-Gonzalez, Angel Comulada-Rivera, Eugenia Galindo Ramos, Jose Cangiano, Luis Quesada-Suarez, Ricardo Calderon Ortiz, Jose Vazquez-Tanus, Rafael Burgos-Calderon, Carlos Rosado, Nicolae Hancu, Ella Pintilei, Cristina Mistodie, Gabriel Bako, Lavinia Ionutiu, Ligia Petrica, Romulus Timar, Liliana Tuta, Livia Duma, Adriana Tutescu, Svetlana Ivanova, Ashot Essaian, Konstantin Zrazhevskiy, Natalia Tomilina, Elena Smolyarchuk, Anatoly Kuzin, Olga Lantseva, Irina Karpova, Minara Shamkhalova, Natalia Liberanskaya, Andrey Yavdosyuk, Yuri Shvarts, Tatiana Bardymova, Olga Blagoveshchenskaya, Oleg Solovev, Elena Rechkova, Natalia Pikalova, Maria Pavlova, Elena Kolmakova, Rustam Sayfutdinov, Svetlana Villevalde, Natalya Koziolova, Vladimir Martynenko, Vyacheslav Marasaev, Adelya Maksudova, Olga Sigitova, Viktor Mordovin, Vadim Klimontov, Yulia Samoylova, Tatiana Karonova, Lee Ying Yeoh, Boon Wee Teo, Marjorie Wai Yin Foo, Adrian Liew, Ivan Tkac, Aniko Oroszova, Jozef Fekete, Jaroslav Rosenberger, Ida Obetkova, Alla Fulopova, Eva Kolesarova, Katarina Raslova, Peter Smolko, Adrian Oksa, Larry Distiller, Julien Trokis, Luthando Adams, Hemant Makan, Padaruth Ramlachan, Essack Mitha, Kathleen Coetzee, Zelda Punt, Qasim Bhorat, Puvenesvari Naiker, Graham Ellis, Louis Van Zyl, Kwan Woo Lee, Min Seon Kim, Soon-Jib Yoo, Kun Ho Yoon, Yong-Wook Cho, Tae-Sun Park, Sang Yong Kim, Moon-Gi Choi, Tae Keun Oh, Kang-Wook Lee, Ho Sang Shon, Sung Hwan Suh, Byung-Joon Kim, Kim Doo-Man, Joo Hark Yi, Sang Ah Lee, Ho Chan Cho, Sin-Gon Kim, Dae-Ryong Cha, Ji A Seo, Kyung Mook Choi, Jeong-Taek Woo, Kyu Jeung Ahn, Jae Hyuk Lee, In-Joo Kim, Moon-Kyu Lee, Hak Chul Jang, Kyong-Soo Park, Beom Seok Kim, Ji Oh Mok, Mijung Shin, Sun Ae Yoon, Il-Seong Nam-Goong, Choon Hee Chung, Tae Yang Yu, Hyoung Woo Lee, Alfonso Soto Gonzalez, Jaume Almirall, Jesus Egido, Francesca Calero Gonzalez, Gema Fernandez Fresnedo, Ildefonso Valera Cortes, Manuel Praga Terente, Isabel Garcia Mendez, Juan Navarro Gonzalez, Jose Herrero Calvo, Secundino Cigarran Guldris, Mario Prieto Velasco, Jose Ignacio Minguela Pesquera, Antonio Galan, Julio Pascual, Maria Marques Vidas, Judith Martins Munoz, Jose Rodriguez-Perez, Cristina Castro-Alonso, Josep Bonet Sol, Daniel Seron, Elvira Fernandez Giraldez, Javier Arrieta Lezama, Nuria Montero, Julio Hernandez-Jaras, Rafael Santamaria Olmo, Jose Ramon Molas Coten, Olof Hellberg, Bengt Fellstrom, Andreas Bock, Dee Pei, Ching-Ling Lin, Kai-Jen Tien, Ching-Chu Chen, Chien-Ning Huang, Ju-Ying Jiang, Du-An Wu, Chih-Hsun Chu, Shih-Ting Tseng, Jung-Fu Chen, Cho-Tsan Bau, Wayne Sheu, Mai-Szu Wu, Ramazan Sari, Siren Sezer, Alaattin Yildiz, Ilhan Satman, Betul Kalender, Borys Mankovskyy, Ivan Fushtey, Mykola Stanislavchuk, Mykola Kolenyk, Iryna Dudar, Viktoriia Zolotaikina, Orest Abrahamovych, Tetyana Kostynenko, Olena Petrosyan, Petro Kuskalo, Olga Galushchak, Oleg Legun, Ivan Topchii, Liliya Martynyuk, Vasyl Stryzhak, Svitlana Panina, Sergii Tkach, Vadym Korpachev, Peter Maxwell, Luigi Gnudi, Sui Phin Kon, Hilary Tindall, Phillip Kalra, Patrick Mark, Dipesh Patel, Mohamed El-Shahawy, Liqun Bai, Romanita Nica, Yeong-Hau Lien, Judson Menefee, Robert Busch, Alan Miller, Azazuddin Ahmed, Ahmed Arif, Joseph Lee, Sachin Desai, Shweta Bansal, Marie Bentsianov, Mario Belledonne, Charles Jere, Raul Gaona, Gregory Greenwood, Osvaldo Brusco, Mark Boiskin, Diogo Belo, Raffi Minasian, Naveen Atray, Mary Lawrence, John Taliercio, Pablo Pergola, David Scott, German Alvarez, Bradley Marder, Thomas Powell, Wa'el Bakdash, George Stoica, Christopher McFadden, Marc Rendell, Jonathan Wise, Audrey Jones, Michael Jardula, Ivy-Joan Madu, Freemu Varghese, Brian Tulloch, Ziauddin Ahmed, Melanie Hames, Imran Nazeer, Newman Shahid, Rekha John, Manuel Montero, David Fitz-Patrick, Lawrence Phillips, Antonio Guasch, Elena Christofides, Aijaz Gundroo, Mohammad Amin, Cynthia Bowman-Stroud, Michael Link, Laura Mulloy, Michael Nammour, Tarik Lalwani, Lenita Hanson, Adam Whaley-Connell, Lee Herman, Rupi Chatha, Sayed Osama, Kenneth Liss, Zeid Kayali, Anuj Bhargava, Ezra Israel, Alfredo Peguero-Rivera, Michael Fang, Judith Slover, Elena Barengolts, Jose Flores, Rosemary Muoneke, Virginia Savin, Stella Awua-Larbi, Andrew Levine, George Newman, Laden Golestaneh, Guillermo Bohm, Efrain Reisin, Lucita Cruz, Robert Weiss, Franklin Zieve, Edward Horwitz, Peale Chuang, James Mersey, John Manley, Ronald Graf, Fadi Bedros, Sudhir Joshi, Juan Frias, Ali Assefi, Andrew O'Shaughnessy, Roman Brantley, Todd Minga, David Tietjen, Samuel Kantor, Aamir Jamal, Ramon Guadiz, Kenneth Hershon, Peter Bressler, Nelson Kopyt, Harold Cathcart, Scott Bloom, Ronald Reichel, Samer Nakhle, Emily Dulude, Joshua Tarkan, Penelope Baker, Steven Zeig, Jaynier Moya Hechevarria, Armando Ropero-Cartier, Gilda De la Calle, Ankur Doshi, Fadi Saba, Teresa Sligh, Sylvia Shaw, Jayant Kumar, Harold Szerlip, George Bayliss, Alan Perlman, Lakhi Sakhrani, Steven Gouge, Georges Argoud, Idalia Acosta, John Elder, Sucharit Joshi, John Sensenbrenner, Steven Vicks, Roberto Mangoo-Karim, Claude Galphin, Carlos Leon-Forero, John Gilbert, Eric Brown, Adeel Ijaz, Salman Butt, Mariana Markell, Carlos Arauz-Pacheco, Lance Sloan, Odilon Alvarado, Serge Jabbour, Eric Simon, Anjay Rastogi, Sam James, Karen Hall, John Melish, Brad Dixon, Allen Adolphe, Csaba Kovesdy, Srinivasan Beddhu, Richard Solomon, Ronald Fernando, Ellis Levin, Charuhas Thakar, Brooks Robey, David Goldfarb, Linda Fried, Geetha Maddukuri, Stephen Thomson, Andrew Annand, Saeed Kronfli, Paramjit Kalirao, Rebecca Schmidt, Neera Dahl, Samuel Blumenthal, Debra Weinstein, Ove Ostergaard, Talia Weinstein, Yasuhiro Ono, Murat Yalcin, Shahana Karim, APH - Health Behaviors & Chronic Diseases, Nephrology, ACS - Amsterdam Cardiovascular Sciences, ACS - Microcirculation, Biomedical Signals and Systems, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Groningen Kidney Center (GKC), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Heerspink, H. J. L., Parving, H. -H., Andress, D. L., Bakris, G., Correa-Rotter, R., Hou, F. -F., Kitzman, D. W., Kohan, D., Makino, H., Mcmurray, J. J. V., Melnick, J. Z., Miller, M. G., Pergola, P. E., Perkovic, V., Tobe, S., Yi, T., Wigderson, M., de Zeeuw, D., Elbert, A., Vallejos, A., Alvarisqueta, A., Maffei, L., Juncos, L., de Arteaga, J., Greloni, G., Farias, E., Zucchini, A., Vogel, D., Cusumano, A., Santos, J., Fraenkel, M., Gallagher, M., Davis, T., Acharya, S., Cooke, D., Suranyi, M., Roger, S., Toussaint, N., Pollock, C., Chan, D., Stranks, S., Macisaac, R., Endre, Z., Schmidt, A., Prager, R., Mayer, G., Warling, X., Jadoul, M., Hougardy, J., Vercammen, C., Van Vlem, B., Gillard, P., Costa e Forti, A., Borges, J. L., Santos Canani, L., Eliaschewitz, F., Leite, S., Fraige Filho, F., Paschoalin, R., Moura Neto, J. A., Deboni, L., de Lourdes Noronha, I., Cercato, C., Prompt, C. A., Zanella, M., Rassi, N., D'Avila, D., Milagres, R., Felicio, J., Pecoits Filho, R., Riella, M. C., Salles, J., Keitel, E., Draibe, S., Amodeo, C., Youmbissi, J., Roy, L., Cournoyer, S., Jolly, S., Pichette, V., Nesrallah, G., Bajaj, H. S., Khandwala, H., Aronson, R., Goluch, R., Tam, P., Rabbat, C., Bailey, G., Chow, S., Castillo, A., Danin Vargas, A., Gonzalez, F., Munoz, R., Gutierrez, V., Godoy, G., Zhao, H., Liu, Z., Zhao, M., Guo, X., Su, B., Fu, S., Xu, Y., Yang, J., Shi, B., Xiao, G., Shi, W., Hao, C., Xing, C., Hou, F., Luo, Q., Li, Y., Ji, L., Zuo, L., Wang, S., Ni, Z., Ding, G., Chen, N., Zhao, J., Jia, W., Yu, S., Weng, J., Xu, G., Fu, P., Sun, S., Liu, B., Ding, X., Rychlik, I., Oplustilova, A., Bartaskova, D., Honova, V., Chmelickova, H., Petr, M., Bucek, P., Tesar, V., Zahumensky, E., Povlsen, J., Egstrup, K., Oczachowska-Kulik, A., Rossing, P., Lahtela, J., Strand, J., Kantola, I., Petit, C., Combe, C., Zaoui, P., Esnault, V., Urena Torres, P., Halimi, J. -M., Dussol, B., Bieler, T., Budde, K., Dellanna, F., Segiet, T., Kosch, C., Schmidt-Guertler, H., Schenkenberger, I., Vielhauer, V., Pistrosch, F., Alscher, M., Hasslacher, C., Hugo, C., Muehlfeld, A., Wanner, C., Passadakis, P., Apostolou, T., Tentolouris, N., Stefanidis, I., Mavromatidis, K., Liakopoulos, V., Goumenos, D., Siamopoulos, K., Yeung, V., Ozaki, R., Fung, S., Tan, K., Tang, S., Lui, S. L., Cheung, S. F., Sreenan, S., Eustace, J., O'Shea, D., Lavin, P., Stack, A., Yagil, Y., Wainstein, J., Knobler, H., Cohen, J., Kenis, I., Daoud, D., Bar-Dayan, Y., Frajewicki, V., Adawi, F., Gesualdo, L., Santoro, D., Marino, F., Galfre, A., Brunati, C., Ruggenenti, P., Rombola, G., Pugliese, G., Ravera, M., Malberti, F., Pontoriero, G., Rampino, T., De Cosmo, S., Esposito, C., Nappi, F., Abaterusso, C., Conte, G., Panichi, V., Lauro, D., Capasso, G., Russo, D., Anzai, J., Naka, M., Ato, K., Tsujimoto, T., Nimura, T., Nakashima, E., Takeda, T., Fujii, S., Kobayashi, K., Iwaoka, H., Nagayama, K., Harada, H., Maeda, H., Kishimoto, R., Iitsuka, T., Itabashi, N., Furuya, R., Maeda, Y., Yamada, D., Sasaki, N., Sasaki, H., Ueda, S., Kashihara, N., Watanabe, S., Nakamura, T., Kanai, H., Makita, Y., Ono, K., Iehara, N., Goto, D., Kosuge, K., Tsuchida, K., Sato, T., Sekikawa, T., Okamoto, H., Tanaka, T., Ikeda, N., Tadika, T., Mukasa, K., Osonoi, T., Hirano, F., Nishimura, M., Yambe, Y., Tanaka, Y., Ujihara, M., Sakai, T., Imura, M., Umayahara, Y., Makino, S., Nakazawa, J., Yamaguchi, Y., Kashine, S., Miyaoka, H., Suzuki, K., Inoue, T., Nagai, S., Sato, N., Yamamoto, M., Taya, N., Fujita, A., Matsutani, A., Shibagaki, Y., Sato, Y., Yamauchi, A., Tsutsui, M., Ishiko, T., Kaneko, S., Azuma, N., Matsuda, H., Hashiguchi, Y., Onishi, Y., Tokui, M., Matsuhisa, M., Kiyosue, A., Shinoda, J., Ishikawa, K., Ahmad, G., Vijayasingham, S., Aziz, N. 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A., Herrada Orue, B., Medina-Santander, B., Delgado-Butron, C., Farfan-Aspilcueta, J., Mazur, S., Necki, M., Wruk, M., Klodawska, K., Popenda, G., Skokowska, E., Arciszewska, M., Wiecek, A., Ciechanowski, K., Nowicki, M., Birne, R., Cabrita, A., Ramos, A., Antunes Ferreira, M. A., Matta Fontanet, E., Alcantara-Gonzalez, A. A., Comulada-Rivera, A., Galindo Ramos, E., Cangiano, J., Quesada-Suarez, L., Calderon Ortiz, R., Vazquez-Tanus, J., Burgos-Calderon, R., Rosado, C., Hancu, N., Pintilei, E., Mistodie, C., Bako, G., Ionutiu, L., Petrica, L., Timar, R., Tuta, L., Duma, L., Tutescu, A., Ivanova, S., Essaian, A., Zrazhevskiy, K., Tomilina, N., Smolyarchuk, E., Kuzin, A., Lantseva, O., Karpova, I., Shamkhalova, M., Liberanskaya, N., Yavdosyuk, A., Shvarts, Y., Bardymova, T., Blagoveshchenskaya, O., Solovev, O., Rechkova, E., Pikalova, N., Pavlova, M., Kolmakova, E., Sayfutdinov, R., Villevalde, S., Koziolova, N., Martynenko, V., Marasaev, V., Maksudova, A., Sigitova, O., Mordovin, V., Klimontov, V., Samoylova, Y., Karonova, T., Yeoh, L. Y., Teo, B. W., Foo, M. W. Y., Liew, A., Tkac, I., Oroszova, A., Fekete, J., Rosenberger, J., Obetkova, I., Fulopova, A., Kolesarova, E., Raslova, K., Smolko, P., Oksa, A., Distiller, L., Trokis, J., Adams, L., Makan, H., Ramlachan, P., Mitha, E., Coetzee, K., Punt, Z., Bhorat, Q., Naiker, P., Ellis, G., Van Zyl, L., Lee, K. W., Kim, M. S., Yoo, S. -J., Yoon, K. H., Cho, Y. -W., Park, T. -S., Kim, S. Y., Choi, M. -G., Oh, T. K., Lee, K. -W., Shon, H. S., Suh, S. H., Kim, B. -J., Doo-Man, K., Yi, J. H., Lee, S. A., Cho, H. C., Kim, S. -G., Cha, D. -R., Seo, J. A., Choi, K. M., Woo, J. -T., Ahn, K. J., Lee, J. H., Kim, I. -J., Lee, M. -K., Jang, H. C., Park, K. -S., Kim, B. S., Mok, J. O., Shin, M., Yoon, S. A., Nam-Goong, I. -S., Chung, C. H., Yu, T. Y., Lee, H. W., Soto Gonzalez, A., Almirall, J., Egido, J., Calero Gonzalez, F., Fernandez Fresnedo, G., Valera Cortes, I., Praga Terente, M., Garcia Mendez, I., Navarro Gonzalez, J., Herrero Calvo, J., Cigarran Guldris, S., Prieto Velasco, M., Minguela Pesquera, J. I., Galan, A., Pascual, J., Marques Vidas, M., Martins Munoz, J., Rodriguez-Perez, J., Castro-Alonso, C., Bonet Sol, J., Seron, D., Fernandez Giraldez, E., Arrieta Lezama, J., Montero, N., Hernandez-Jaras, J., Santamaria Olmo, R., Molas Coten, J. R., Hellberg, O., Fellstrom, B., Bock, A., Pei, D., Lin, C. -L., Tien, K. -J., Chen, C. -C., Huang, C. -N., Jiang, J. -Y., Wu, D. -A., Chu, C. -H., Tseng, S. -T., Chen, J. -F., Bau, C. -T., Sheu, W., Wu, M. -S., Sari, R., Sezer, S., Yildiz, A., Satman, I., Kalender, B., Mankovskyy, B., Fushtey, I., Stanislavchuk, M., Kolenyk, M., Dudar, I., Zolotaikina, V., Abrahamovych, O., Kostynenko, T., Petrosyan, O., Kuskalo, P., Galushchak, O., Legun, O., Topchii, I., Martynyuk, L., Stryzhak, V., Panina, S., Tkach, S., Korpachev, V., Maxwell, P., Gnudi, L., Kon, S. P., Tindall, H., Kalra, P., Mark, P., Patel, D., El-Shahawy, M., Bai, L., Nica, R., Lien, Y. -H., Menefee, J., Busch, R., Miller, A., Ahmed, A., Arif, A., Lee, J., Desai, S., Bansal, S., Bentsianov, M., Belledonne, M., Jere, C., Gaona, R., Greenwood, G., Brusco, O., Boiskin, M., Belo, D., Minasian, R., Atray, N., Lawrence, M., Taliercio, J., Pergola, P., Scott, D., Alvarez, G., Marder, B., Powell, T., Bakdash, W., Stoica, G., Mcfadden, C., Rendell, M., Wise, J., Jones, A., Jardula, M., Madu, I. -J., Varghese, F., Tulloch, B., Ahmed, Z., Hames, M., Nazeer, I., Shahid, N., John, R., Montero, M., Fitz-Patrick, D., Phillips, L., Guasch, A., Christofides, E., Gundroo, A., Amin, M., Bowman-Stroud, C., Link, M., Mulloy, L., Nammour, M., Lalwani, T., Hanson, L., Whaley-Connell, A., Herman, L., Chatha, R., Osama, S., Liss, K., Kayali, Z., Bhargava, A., Israel, E., Peguero-Rivera, A., Fang, M., Slover, J., Barengolts, E., Flores, J., Muoneke, R., Savin, V., Awua-Larbi, S., Levine, A., Newman, G., Golestaneh, L., Bohm, G., Reisin, E., Cruz, L., Weiss, R., Zieve, F., Horwitz, E., Chuang, P., Mersey, J., Manley, J., Graf, R., Bedros, F., Joshi, S., Frias, J., Assefi, A., O'Shaughnessy, A., Brantley, R., Minga, T., Tietjen, D., Kantor, S., Jamal, A., Guadiz, R., Hershon, K., Bressler, P., Kopyt, N., Cathcart, H., Bloom, S., Reichel, R., Nakhle, S., Dulude, E., Tarkan, J., Baker, P., Zeig, S., Moya Hechevarria, J., Ropero-Cartier, A., De la Calle, G., Doshi, A., Saba, F., Sligh, T., Shaw, S., Kumar, J., Szerlip, H., Bayliss, G., Perlman, A., Sakhrani, L., Gouge, S., Argoud, G., Acosta, I., Elder, J., Sensenbrenner, J., Vicks, S., Mangoo-Karim, R., Galphin, C., Leon-Forero, C., Gilbert, J., Brown, E., Ijaz, A., Butt, S., Markell, M., Arauz-Pacheco, C., Sloan, L., Alvarado, O., Jabbour, S., Simon, E., Rastogi, A., James, S., Hall, K., Melish, J., Dixon, B., Adolphe, A., Kovesdy, C., Beddhu, S., Solomon, R., Fernando, R., Levin, E., Thakar, C., Robey, B., Goldfarb, D., Fried, L., Maddukuri, G., Thomson, S., Annand, A., Kronfli, S., Kalirao, P., Schmidt, R., Dahl, N., Blumenthal, S., Weinstein, D., Ostergaard, O., Weinstein, T., Ono, Y., Yalcin, M., Karim, S., Pathology/molecular and cellular medicine, Diabetes Pathology & Therapy, and Diabetes Clinic
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Male ,endothelin ,albuminuria ,nephropathy ,inhibition ,Diabetes Mellitus, Type 2/drug therapy ,Endocrinology, Diabetes and Metabolism ,Placebo-controlled study ,Administration, Oral ,030204 cardiovascular system & hematology ,Settore MED/13 - Endocrinologia ,chemistry.chemical_compound ,0302 clinical medicine ,ENDOTHELIN ,80 and over ,Diabetic Nephropathies ,030212 general & internal medicine ,Renal Insufficiency ,Chronic ,Aged, 80 and over ,Diabetic Nephropathies/blood ,General Medicine ,Middle Aged ,Atrasentan/administration & dosage ,Editorial Commentary ,Treatment Outcome ,Nephrology ,Creatinine ,Administration ,young adult ,Female ,medicine.symptom ,Glomerular filtration rate ,Type 2 ,Endothelin A Receptor Antagonists/administration & dosage ,medicine.drug ,Glomerular Filtration Rate ,Human ,Oral ,Adult ,medicine.medical_specialty ,ALBUMINURIA ,Endothelin A Receptor Antagonists ,NEPHROPATHY ,Urology ,INHIBITION ,Renal function ,Serum Albumin, Human ,Placebo ,Nephropathy ,03 medical and health sciences ,Young Adult ,Double-Blind Method ,Atresentan ,diabetes, chronic kidney disease ,medicine ,Diabetes Mellitus ,Aged ,Atrasentan ,Diabetes Mellitus, Type 2 ,Humans ,Renal Insufficiency, Chronic ,Serum Albumin ,business.industry ,Creatinine/blood ,medicine.disease ,Serum Albumin, Human/urine ,n/a OA procedure ,chemistry ,Albuminuria ,Renal Insufficiency, Chronic/blood ,business ,aged, 80 and over ,Kidney disease - Abstract
Background Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes.Methods We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18-85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR) 25-75 mL/min per 1.73 m(2) of body surface area, and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g who had received maximum labelled or tolerated renin-angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0.75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders) were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0.75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for >= 30 days) or end-stage kidney disease (eGFR = 90 days, chronic dialysis for >= 90 days, kidney transplantation, or death from kidney failure) in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials. gov, number NCT01858532.Findings Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325) or placebo group (n=1323). Median follow-up was 2.2 years (IQR 1.4-2.9). 79 (6.0%) of 1325 patients in the atrasentan group and 105 (7.9%) of 1323 in the placebo group had a primary composite renal endpoint event (hazard ratio [HR] 0.65 [95% CI 0.49-0.88]; p=0.0047). Fluid retention and anaemia adverse events, which have been previously attributed to endothelin receptor antagonists, were more frequent in the atrasentan group than in the placebo group. Hospital admission for heart failure occurred in 47 (3.5%) of 1325 patients in the atrasentan group and 34 (2.6%) of 1323 patients in the placebo group (HR 1.33 [95% CI 0.85-2.07]; p=0.208). 58 (4.4%) patients in the atrasentan group and 52 (3.9%) in the placebo group died (HR 1.09 [95% CI 0.75-1.59]; p=0.65).Interpretation Atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease who were selected to optimise efficacy and safety. These data support a potential role for selective endothelin receptor antagonists in protecting renal function in patients with type 2 diabetes at high risk of developing end-stage kidney disease. Copyright (C) 2019 Elsevier Ltd. All rights reserved.
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- 2019
23. Sequential fibrate and low-dose simvastatin treatment in 6422 patients with severe hypercholesterolemia: The Belgian General Practitioner's Study
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Muls, E., Vercammen, C., and Vansant, G.
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- 1994
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24. Efficacy analysis by age of low-dose simvastatin in 3032 patients with primary hypercholesterolemia: The Belgian General Practitioner's Study
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Muls, E., Vansant, G., and Vercammen, C.
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- 1994
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25. Impact of breastfeeding on risk of glucose intolerance in early postpartum after gestational diabetes.
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Vanlaer Y, Minschart C, Vrolijk H, Van Crombrugge P, Moyson C, Verhaeghe J, Devlieger R, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Van Pottelbergh I, Myngheer N, Abrams P, Vinck W, Leuridan L, Driessens S, Billen J, Matthys C, Bogaerts A, Laenen A, Mathieu C, and Benhalima K
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- Humans, Female, Pregnancy, Adult, Prospective Studies, Risk Factors, Blood Glucose metabolism, Diabetes, Gestational, Breast Feeding, Glucose Intolerance epidemiology, Glucose Intolerance etiology, Postpartum Period
- Abstract
Aims: To determine the impact of breastfeeding on the risk of postpartum glucose intolerance in women with gestational diabetes., Methods: Sub-analysis of two multi-centric prospective cohort studies (BEDIP-N and MELINDA) in 1008 women with gestational diabetes. Data were collected during pregnancy and at a mean of 12 weeks postpartum. Multivariate logistic regression was used to estimate the effect of breastfeeding on glucose intolerance, with adjustment for ethnicity, education, income, professional activity and BMI., Results: Of all participants, 56.3% (567) breastfed exclusively, 10.1% (102) gave mixed milk feeding and 33.6% (339) did not breastfeed. Mean breastfeeding duration was 3.8 ± 2.4 and 3.7 ± 2.1 months in the breastfeeding and mixed milk feeding groups (p=0.496). The rate of glucose intolerance was lower in both the breastfeeding [22.3% (126)] and mixed milk feeding [25.5% (26)] groups compared to the no breastfeeding group [29.5% (100)], with an adjusted OR of 0.7 (95% CI 0.5-1.0) for glucose intolerance in the breastfeeding group compared to no breastfeeding group and an adjusted OR of 0.7 (95% CI 0.4-1.2) for the mixed milk feeding group compared to the no breastfeeding group. Postpartum, breastfeeding women had a lower BMI, less often postpartum weight retention, lower fasting triglycerides, less insulin resistance and a higher insulin secretion-sensitivity index-2 than the mixed milk feeding and no breastfeeding group. The mixed milk feeding group was more often from an non-White background, had a lower blood pressure and lower fasting triglycerides compared to the no breastfeeding group., Conclusions: Breastfeeding (exclusive and mixed milk feeding) is associated with less glucose intolerance and a better metabolic profile in early postpartum in women with gestational diabetes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Vanlaer, Minschart, Vrolijk, Van Crombrugge, Moyson, Verhaeghe, Devlieger, Vandeginste, Verlaenen, Vercammen, Maes, Dufraimont, Roggen, De Block, Jacquemyn, Mekahli, De Clippel, Van Den Bruel, Loccufier, Van Pottelbergh, Myngheer, Abrams, Vinck, Leuridan, Driessens, Billen, Matthys, Bogaerts, Laenen, Mathieu and Benhalima.)
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- 2024
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26. The Impact of Baseline User Characteristics on the Benefits of Real-Time Versus Intermittently Scanned Continuous Glucose Monitoring in Adults With Type 1 Diabetes: Moderator Analyses of the ALERTT1 Trial.
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Visser MM, Charleer S, Fieuws S, De Block C, Hilbrands R, Van Huffel L, Maes T, Vanhaverbeke G, Dirinck E, Myngheer N, Vercammen C, Nobels F, Keymeulen B, Mathieu C, and Gillard P
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- Adult, Female, Humans, Male, Middle Aged, Young Adult, Blood Glucose analysis, Glycated Hemoglobin analysis, Glycemic Control, Hypoglycemia blood, Hypoglycemia chemically induced, Hypoglycemia prevention & control, Hypoglycemia diagnosis, Insulin administration & dosage, Insulin therapeutic use, Insulin Infusion Systems, Continuous Glucose Monitoring, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents therapeutic use
- Abstract
Background: ALERTT1 showed that switching from intermittently scanned continuous glucose monitoring (isCGM) without alerts to real-time CGM (rtCGM) with alert functionality improved time in range (TIR; 70-180 mg/dL), glycated hemoglobin (HbA1c), time <54 mg/dL, and Hypoglycemia Fear Survey version II worry subscale (HFS-worry) score after six months in adults with type 1 diabetes (T1D). Moderator analyses aimed to identify certain subgroups that would benefit more from switching to rtCGM than others., Methods: Post hoc analyses of ALERTT1 evaluated the impact of 14 baseline characteristics on the difference (delta) in mean TIR, HbA1c, time <54 mg/dL, and HFS-worry score at six months between rtCGM and isCGM. Therefore, the delta was allowed to depend on each of these variables by including interactions in the moderator analysis model. Analyses were performed separately for each variable; variables with P < .10 in the univariable analysis were combined into a single model., Results: Univariable analyses showed no dependency of delta TIR, HbA1c, or time <54 mg/dL on variables other than CGM type. Only delta HFS-worry score depended on baseline HbA1c ( P = .0059), indicating less worries with rtCGM in people with baseline HbA1c <6.5% or ≥8%. Given P < .10 for dependency of delta TIR on insulin therapy type (favoring multiple daily injections), baseline HbA1c, and baseline TIR, these variables were combined into a multivariable analysis; interactions were not statistically significant., Conclusions: Except for HFS-worry score, no interactions between 14 baseline characteristics and the six-month intervention effect of rtCGM on TIR, HbA1c, or time <54 mg/dL were observed, supporting the conclusion of ALERTT1 that switching from isCGM without alerts to rtCGM with alert functionality is beneficial for a wide range of people with T1D., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: UZ Leuven received nonfinancial support for travel from Novo Nordisk, and Boehringer-Ingelheim for M.M.V. M.M.V. serves or has served on the speakers bureau for Dexcom—financial compensation for these activities has been received by KU Leuven. KU Leuven received nonfinancial support for travel from Medtronic, and financial support for travel from Roche for S.C. C.D.B. reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer-Ingelheim, A. Menarini Diagnostics, Eli Lilly, Medtronic, Novo Nordisk, and Roche. R.H. serves or has served on the advisory panel for Merck Sharp and Dohme, Boehringer-Ingelheim, and Eli Lilly. L.V.H. reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Medtronic, Merck Sharp and Dohme, Novo Nordisk, and Sanofi-Aventis. G.V. serves or has served on the advisory panel for Merck Sharp and Dohme, Boehringer-Ingelheim, and Eli Lilly. G.V. reports consulting fees and honoraria for speaking from Merck Sharp and Dohme, Boehringer-Ingelheim, AstraZeneca, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. E.D. has served on the advisory panel for Novo Nordisk. E.D. reports speaking fees from Novo Nordisk, Boehringer-Ingelheim, Eli Lilly, and AstraZeneca. N.M. serves or has served on the advisory panel for Boehringer-Ingelheim. N.M. reports speaking fees from Merck Sharp and Dohme, Boehringer-Ingelheim, AstraZeneca, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. C.V. reports consulting and speaking fees from Medtronic, Boehringer-Ingelheim, AstraZeneca, and Sanofi-Aventis. F.N. reports consulting fees and honoraria for speaking from Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Johnson and Johnson, Medtronic, Merck Sharp and Dohme, Novo Nordisk, Roche, and Sanofi-Aventis. C.M. serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, and Zealand Pharma. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for C.M. from Medtronic, Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Roche, Abbott, ActoBio Therapeutics, and Novartis; C.M. serves or has served on the speakers bureau for Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Boehringer-Ingelheim, AstraZeneca, and Novartis. Financial compensation for these activities has been received by KU Leuven. P.G. serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Boehringer-Ingelheim, Janssen Pharmaceuticals, Roche, Medtronic, and Bayer. Financial compensation for these activities has been received by KU Leuven. P.G. serves or has served on the speakers bureau for Merck Sharp and Dohme, Boehringer-Ingelheim, Bayer, Medtronic, Insulet, Novo Nordisk, Abbott, Roche, and Dexcom. Financial compensation for these activities has been received by KU Leuven. KU Leuven received nonfinancial support for travel from Sanofi-Aventis, A. Menarini Diagnostics, Medtronic, and Roche for P.G. All disclosures were unrelated to the present work. S.F., T.M., and B.K. have nothing to disclose.
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- 2024
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27. Normal glucose tolerant women with low glycemia during the oral glucose tolerance test have a higher risk to deliver a low birth weight infant.
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Raets L, Van Doninck L, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, and Benhalima K
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- Infant, Newborn, Female, Pregnancy, Humans, Glucose Tolerance Test, Birth Weight, Blood Glucose metabolism, Prospective Studies, Infant, Low Birth Weight, Gestational Weight Gain, Diabetes, Gestational metabolism, Hyperglycemia
- Abstract
Background: Data are limited on pregnancy outcomes of normal glucose tolerant (NGT) women with a low glycemic value measured during the 75g oral glucose tolerance test (OGTT). Our aim was to evaluate maternal characteristics and pregnancy outcomes of NGT women with low glycemia measured at fasting, 1-hour or 2-hour OGTT., Methods: The Belgian Diabetes in Pregnancy-N study was a multicentric prospective cohort study with 1841 pregnant women receiving an OGTT to screen for gestational diabetes (GDM). We compared the characteristics and pregnancy outcomes in NGT women according to different groups [(<3.9mmol/L), (3.9-4.2mmol/L), (4.25-4.4mmol/L) and (>4.4mmol/L)] of lowest glycemia measured during the OGTT. Pregnancy outcomes were adjusted for confounding factors such as body mass index (BMI) and gestational weight gain., Results: Of all NGT women, 10.7% (172) had low glycemia (<3.9 mmol/L) during the OGTT. Women in the lowest glycemic group (<3.9mmol/L) during the OGTT had compared to women in highest glycemic group (>4.4mmol/L, 29.9%, n=482), a better metabolic profile with a lower BMI, less insulin resistance and better beta-cell function. However, women in the lowest glycemic group had more often inadequate gestational weight gain [51.1% (67) vs. 29.5% (123); p<0.001]. Compared to the highest glycemia group, women in the lowest group had more often a birth weight <2.5Kg [adjusted OR 3.41, 95% CI (1.17-9.92); p=0.025]., Conclusion: Women with a glycemic value <3.9 mmol/L during the OGTT have a higher risk for a neonate with birth weight < 2.5Kg, which remained significant after adjustment for BMI and gestational weight gain., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Raets, Van Doninck, Van Crombrugge, Moyson, Verhaeghe, Vandeginste, Verlaenen, Vercammen, Maes, Dufraimont, Roggen, De Block, Jacquemyn, Mekahli, De Clippel, Van Den Bruel, Loccufier, Laenen, Devlieger, Mathieu and Benhalima.)
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- 2023
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28. Real-life and real-time hearing aid experiences: Insights from self-initiated ecological momentary assessments and natural language analysis.
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Vercammen C, Oosthuizen I, Manchaiah V, Ratinaud P, Launer S, and Swanepoel W
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Introduction: Smartphone technology can provide an effective means to bring real-life and (near-)real-time feedback from hearing aid wearers into the clinic. Ecological Momentary Assessment (EMA) encourages listeners to report on their experiences during or shortly after they take place in order to minimize recall bias, e.g., guided by surveys in a mobile application. Allowing listeners to describe experiences in their own words, further, ensures that answers are independent of predefined jargon or of how survey questions are formulated. Through these means, one can obtain ecologically valid sets of data, for instance during a hearing aid trial, which can support clinicians to assess the needs of their clients, provide directions for fine-tuning, and counselling. At a larger scale, such datasets would facilitate training of machine learning algorithms that could help hearing technology to anticipate user needs., Methods: In this retrospective, exploratory analysis of a clinical data set, we performed a cluster analysis on 8,793 open-text statements, which were collected through self-initiated EMAs, provided by 2,301 hearing aid wearers as part of their hearing care. Our aim was to explore how listeners describe their daily life experiences with hearing technology in (near-)real-time, in their own words, by identifying emerging themes in the reports. We also explored whether identified themes correlated with the nature of the experiences, i.e., self-reported satisfaction ratings indicating a positive or negative experience., Results: Results showed that close to 60% of listeners' reports related to speech intelligibility in challenging situations and sound quality dimensions, and tended to be valued as positive experiences. In comparison, close to 40% of reports related to hearing aid management, and tended to be valued as negative experiences., Discussion: This first report of open-text statements, collected through self-initiated EMAs as part of clinical practice, shows that, while EMA can come with a participant burden, at least a subsample of motivated hearing aid wearers could use these novel tools to provide feedback to inform more responsive, personalized, and family-centered hearing care., Competing Interests: SL and CV are professionally employed by Sonova AG. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Vercammen, Oosthuizen, Manchaiah, Ratinaud, Launer and Swanepoel.)
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- 2023
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29. Low Gestational Weight Gain in Women With Gestational Diabetes Is Safe With Better Metabolic Profile Postpartum.
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Minschart C, Lammertyn A, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, and Benhalima K
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- Pregnancy, Infant, Newborn, Female, Humans, Weight Gain, Prospective Studies, Pregnancy Outcome, Postpartum Period, Glucose, Body Mass Index, Diabetes, Gestational epidemiology, Gestational Weight Gain, Hypoglycemia epidemiology, Hypoglycemia etiology
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Context: More data are needed on the potential benefits and risks of gestational weight gain (GWG) less than recommended and excessive GWG in women with gestational diabetes (GDM) compared to women with normal glucose tolerance (NGT) during pregnancy., Objective: This work aimed to evaluate association of gestational weight gain (GWG) as low, within, or above (excessive) according to Institute of Medicine (IOM) guidelines, with pregnancy outcomes in women with gestational diabetes (GDM) and normal glucose tolerance (NGT)., Methods: This prospective cohort study included 7 Belgian hospitals and 1843 women receiving universal GDM screening with a 75-g oral glucose tolerance test. Pregnancy outcomes and postpartum characteristics were the main outcome measures., Results: Women with GDM and low GWG (n = 97, 52.4%) had similar rates of small-for-gestational age infants and preterm delivery, were less often overweight or obese postpartum (35.7% [30] vs 56.5% [26]; P < .022) and less often had postpartum weight retention (PPWR) (48.8% [41] vs 87.9% [40]; P < .001) compared to GWG within range (n = 58, 31.3%). GDM with excessive GWG (n = 30, 16.2%) more often had neonatal hypoglycemia (30.8% (8) vs 5.9% [3], aOR 7.15; 95% CI, 1.52-33.63; P = .013) compared to GWG within range. NGT with excessive GWG (28.3% [383]) more often had instrumental delivery (15.9% [61] vs 11.9% [64], aOR 1.53; 95% CI, 1.03-2.27; P = .035) and more large-for-gestational age infants (19.3% [74] vs 10.4% [56], aOR 1.67; 95% CI, 1.13-2.47; P = .012) compared to GWG within range., Conclusion: GWG below IOM guidelines occurred frequently in GDM women, without increased risk for adverse pregnancy outcomes and with better metabolic profile postpartum. Excessive GWG was associated with increased risk for neonatal hypoglycemia and worse metabolic profile postpartum in women with GDM, and with higher rates of LGA and instrumental delivery in NGT women., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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30. Effect of switching from intermittently scanned to real-time continuous glucose monitoring in adults with type 1 diabetes: 24-month results from the randomised ALERTT1 trial.
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Visser MM, Charleer S, Fieuws S, De Block C, Hilbrands R, Van Huffel L, Maes T, Vanhaverbeke G, Dirinck E, Myngheer N, Vercammen C, Nobels F, Keymeulen B, Mathieu C, and Gillard P
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- Humans, Adult, Hypoglycemic Agents therapeutic use, Blood Glucose Self-Monitoring methods, Blood Glucose, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia prevention & control
- Abstract
Background: Comparing Continuous With Flash Glucose Monitoring In Adults With Type 1 Diabetes (ALERTT1) examined whether switching from first-generation intermittently scanned continuous glucose monitoring (isCGM) without alerts to real-time continuous glucose monitoring (rtCGM) with alert functionality offers additional benefits to adults with type 1 diabetes. The extension of the randomised ALERTT1 trial assessed the effect of switching from isCGM to rtCGM up to 24 months., Methods: In this 6-month, double-arm, parallel-group, non-masked, randomised, controlled trial, done across six hospitals in Belgium, 254 adults aged 18 years or older with type 1 diabetes previously using isCGM were randomly assigned (1:1) to rtCGM with alerts (intervention; n=127) or isCGM without alerts (control; n=127). Upon completion of the 6-month trial, the control group switched to rtCGM (is-rtCGM group), and the intervention group continued rtCGM (rt-rtCGM group). The extension focused on within-group changes in time in range (TIR; 3·9-10·0 mmol/L; primary outcome), HbA
1c , time in clinically significant hypoglycaemia (<3·0 mmol/L), and Hypoglycaemia Fear Survey worry (HFS-worry) score (all prespecified key secondary outcomes). Mean within-group change versus the start of rtCGM is reported, with a positive value referring to a lower value at start of rtCGM. This trial is registered at ClinicalTrials.gov (NCT03772600)., Findings: 119 participants were assigned to the is-rtCGM group of whom 112 (94%) completed the 24-month trial, and 123 participants were assigned to the rt-rtCGM group of whom 117 (95%) completed the 24-month trial. TIR increased from 51·8% (95% CI 49·1-54·5) at start of rtCGM (month 6) to 63·5% (60·7-66·3) at month 12 in the is-rtCGM group, and remained stable up to month 24 (change 11·7 percentage points [pp] [9·4-14·0; p<0·0001). In the rt-rtCGM group, TIR increased from 52·5% (95% CI 49·8-55·1) at start of rtCGM (month 0) to 63·0% (60·3-65·8) at month 12, also remaining stable up to month 24 (change 10·5 pp [8·2-12·8]; p<0·0001). HbA1c decreased from 7·4% (57 mmol/mol; month 6) to 6·9% (52 mmol/mol) at month 24 (change -0·54 pp [95% CI -0·64 to -0·44]; -5 mmol/mol [95% CI -6 to -4]; p<0·0001) in the is-rtCGM group, and from 7·4% (57 mmol/mol; month 0) to 7·0% (53 mmol/mol) at month 24 (change -0·43 pp [95% CI -0·53 to -0·33]; -4 mmol/mol [95% CI -5 to -3]; p<0·0001) in the rt-rtCGM group. The change in HFS-worry score was -2·67 (month 24 vs month 6; p=0·0008) in the is-rtCGM group and -5·17 points (month 24 vs month 0; p<0·0001) in the rt-rtCGM group. Time in clinically significant hypoglycaemia was unchanged in both groups after month 12. Severe hypoglycaemia decreased from 31·0 to 3·3 per 100 patient-years after switching to rtCGM., Interpretation: Glycaemic control and hypoglycaemia worry improved significantly up to 24 months after switching from isCGM without alerts to rtCGM with alerts, supporting the use of rtCGM in the care of adults with type 1 diabetes., Funding: Dexcom., Competing Interests: Declaration of interests MMV received non-financial support for travel from Novo Nordisk and Boehringer-Ingelheim via UZ Leuven. MMV serves, or has served, on the speakers bureau for Dexcom; financial compensation for this activity has been received by KU Leuven. SC received research support from Roche Diabetes Care, Novo Nordisk, and Sanofi via KU Leuven. CDB reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer-Ingelheim, A Menarini Diagnostics, Indigo Diabetes, Insulet, Eli Lilly, Medtronic, Novo Nordisk, and Roche, and served on the advisory panel for Eli Lilly, Indigo Diabetes, and Novo Nordisk. RH serves, or has served, on the advisory panel for Merck Sharp and Dohme, Boehringer-Ingelheim, and Eli Lilly. LVH reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Medtronic, Merck Sharp and Dohme, Novo Nordisk, Sanofi-Aventis, and Roche. GV serves, or has served, on the advisory panel for Merck Sharp and Dohme, Boehringer-Ingelheim, and Eli Lilly. GV reports consulting fees and honoraria for speaking from Merck Sharp and Dohme, Boehringer-Ingelheim, AstraZeneca, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. ED has served on the advisory panel for Novo Nordisk. ED reports speaking fees from Novo Nordisk, Boehringer-Ingelheim, Eli Lilly, and AstraZeneca. NM serves, or has served, on the advisory panel for Boehringer-Ingelheim. NM reports speaking fees from Merck Sharp and Dohme, Boehringer-Ingelheim, AstraZeneca, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. CV reports consulting and speaking fees from Medtronic, Boehringer Ingelheim, AstraZeneca, and Sanofi Aventis. FN reports consulting fees and honoraria for speaking from Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Johnson and Johnson, Medtronic, Merck Sharp and Dohme, Novo Nordisk, Roche, and Sanofi-Aventis. CM serves, or has served, on the advisory panel for Novo Nordisk, Sanofi, Merck Sharp and Dohme, Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz, and Vertex. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from Medtronic, Imcyse, Novo Nordisk, Sanofi, and ActoBio Therapeutics; CM serves or has served on the speakers bureau for Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca, and Novartis. Financial compensation for these activities has been received by KU Leuven. PG serves, or has served, on the advisory panel for Novo Nordisk, Sanofi-Aventis, Boehringer-Ingelheim, Janssen Pharmaceuticals, Roche, Medtronic, Abbott and Bayer. Financial compensation for these activities has been received by KU Leuven. PG serves, or has served, on the speakers bureau for Merck Sharp and Dohme, Boehringer-Ingelheim, Bayer, Medtronic, Insulet, Novo Nordisk, Abbott, Roche, VitalAire, and Dexcom. Financial compensation for these activities has been received by KU Leuven. KU Leuven received non-financial support for PG for travel from Sanofi-Aventis, A Menarini Diagnostics, Novo Nordisk, Medtronic, and Roche. All disclosures were unrelated to the present work. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)- Published
- 2023
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31. The Belgian Diabetes in Pregnancy Follow-Up Study (BEDIP-FUS): A Multi-Centric Prospective Cohort Study on the Long-Term Metabolic Risk across Different Degrees of Gestational Glucose Intolerance: Methodology and Design.
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Raets L, Van Hoorenbeeck K, Maes T, Vercammen C, De Block C, Dirinck E, Van Pottelbergh I, Wierckx K, Laenen A, Bogaerts A, Mathieu C, and Benhalima K
- Abstract
The Belgian Diabetes in Pregnancy follow-up study (BEDIP-FUS) aims to investigate the impact of body mass index (BMI), adiposity and different degrees of glucose intolerance on the metabolic profile and future risk for type 2 diabetes (T2D) in women and offspring five years after delivery in the BEDIP study. The BEDIP study was a prospective cohort study to evaluate different screening strategies for gestational diabetes (GDM) based on the 2013 WHO criteria. The aim of the BEDIP-FUS is to recruit 375 women-offspring pairs, stratified according to three different subgroups based on the antenatal result of the glucose challenge test (GCT) and oral glucose tolerance test (OGTT) during the BEDIP pregnancy. The follow-up visit consists of a 75 g OGTT, anthropometric measurements and questionnaires for the mothers, and a fasting blood sample with anthropometric measurements for the child. Primary outcome for the mother is glucose intolerance defined by the American Diabetes Association criteria and for the offspring the BMI z-score. Recruitment began in January 2021. The BEDIP-FUS study will help to better individualize follow-up in women with different degrees of hyperglycemia in pregnancy and their offspring.
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- 2023
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32. Higher Thyroid fT3-to-fT4 Ratio Is Associated with Gestational Diabetes Mellitus and Adverse Pregnancy Outcomes.
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Raets L, Minschart C, Van den Bruel A, Van den Bogaert E, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Loccufier A, Laenen A, Devlieger R, Mathieu C, Decallonne B, and Benhalima K
- Abstract
Aim: To determine the association between thyroid function and the risk of developing gestational diabetes mellitus (GDM) and adverse pregnancy outcomes. Methods: This case−control study was a sub-analysis of the BEDIP-N study, in which 199 GDM women were matched for age and body mass index with 398 controls. Thyroid-stimulating hormone (TSH), free thyroxine (fT4), free triiodothyronine (fT3), and thyroid peroxidase (TPO) antibodies were measured at 6−14 weeks and 26−28 weeks during pregnancy. TSH and fT4 were also measured in early postpartum in GDM women. Results: The fT3-to-fT4 ratio at 26−28 weeks was positively associated with GDM risk with an adjusted odds ratio (aOR for smoking, education, parity, ethnicity, gestational weight gain, and (family) history of diabetes or GDM) of 2.12 (95% CI 1.07; 4.23), comparing the highest with the lowest tertile. Higher fT3 levels and a higher fT3-to-fT4 ratio were associated with a less favorable metabolic profile with higher BMI and more insulin resistance during pregnancy and postpartum. Women in the upper fT3 tertile and the upper fT3-to-fT4 ratio had a higher rate of preeclampsia [4.6% (10) vs. 1.0% (2), p = 0.040, and 4.4% (9) vs. 0.5% (1), p = 0.020], gestational hypertension [8.3% (18) vs. 3.1% (6), p = 0.034 and 8.9% (18) vs. 2.0% (4), p = 0.003], and caesarean sections [29.4% (63) vs. 16.1% (31), p = 0.002 and 32.2% (65) vs. 12.7% (25), p < 0.001]. Conclusion: A higher fT3-to-fT4 ratio late into pregnancy was associated with GDM, adverse pregnancy outcomes, and an adverse metabolic profile in early postpartum.
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- 2022
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33. Type 1 diabetes-related autoimmune antibodies in women with gestational diabetes mellitus and the long-term risk for glucose intolerance.
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Beunen K, Vercauter L, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, and Benhalima K
- Subjects
- Autoantibodies, Female, Glucose, Humans, Infant, Newborn, Pregnancy, Prospective Studies, Diabetes Mellitus, Type 1, Diabetes, Gestational, Glucose Intolerance, Prediabetic State
- Abstract
Aims: To characterize women with gestational diabetes mellitus (GDM) positive for type 1 diabetes-related autoimmune antibodies (T1D-related autoantibodies) in pregnancy and to evaluate their risk for long-term glucose intolerance., Methods: In a multi-centric prospective cohort study with 1843 women receiving universal screening for GDM with a 75 g oral glucose tolerance test (OGTT), autoantibodies were measured in women with GDM: insulin autoantibodies (IAA), islet cell antibodies (ICA), insulinoma-associated protein-2 antibodies (IA-2A) and glutamic acid decarboxylase antibodies (GADA). Long-term follow-up ( ± 4.6 years after delivery) with a 75 g OGTT and re-measurement of autoantibodies was done in women with a history of GDM and autoantibody positivity in pregnancy., Results: Of all women with GDM (231), 80.5% (186) received autoantibody measurement at a mean of 26.2 weeks in pregnancy, of which 8.1% (15) had one positive antibody (seven with IAA, two with ICA, four with IA-2A and two with GADA). Characteristics in pregnancy were similar but compared to women without autoantibodies, women with autoantibodies had more often gestational hypertension [33.3% (5) vs. 1.7% (3), p<0.001] and more often neonatal hypoglycemia [40.0% (6) vs. 12.5% (19), p=0.012]. Among 14 of the 15 autoantibody positive women with an early postpartum OGTT, two had impaired fasting glucose (IFG). Of the 12 women with long-term follow-up data, four tested again positive for T1D-related autoantibodies (three positive for IA-2A and one positive for ICA and IAA). Five women were glucose intolerant at the long-term follow-up of which two had IA-2A (one had IFG and one had T1D) and three without autoantibodies. There were no significant differences in long-term characteristics between women with and without autoantibodies postpartum., Conclusions: Systematic screening for T1D-related autoantibodies in GDM does not seem warranted since the low positivity rate for autoantibodies in pregnancy and postpartum. At 4.6 years postpartum, five out of 12 women were glucose intolerant but only two still had autoantibodies. In women with clinically significant increased autoantibody levels during pregnancy, postpartum autoantibody re-measurement seems useful since the high risk for further increase of autoantibody levels., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Beunen, Vercauter, Van Crombrugge, Moyson, Verhaeghe, Vandeginste, Verlaenen, Vercammen, Maes, Dufraimont, Roggen, De Block, Jacquemyn, Mekahli, De Clippel, Van Den Bruel, Loccufier, Laenen, Devlieger, Mathieu and Benhalima.)
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- 2022
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34. Fasting plasma glucose level to guide the need for an OGTT to screen for gestational diabetes mellitus.
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Beunen K, Neys A, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, and Benhalima K
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- Blood Glucose metabolism, Fasting, Female, Fetal Macrosomia, Glucose Tolerance Test, Humans, Pregnancy, Prospective Studies, Diabetes, Gestational diagnosis, Diabetes, Gestational epidemiology
- Abstract
Aims: To determine the fasting plasma glucose (FPG) level at which an oral glucose tolerance test (OGTT) could be avoided to screen for gestational diabetes (GDM) and to evaluate the characteristics of women across this FPG threshold., Methods: A multi-centric prospective cohort study with 1843 women receiving universal screening for GDM with a 75 g OGTT., Results: In the total population, GDM prevalence was 12.5% (231). A FPG < 78 mg/dL was the cut-off with best trade-off to limit the number of missed GDM cases [44 (19.0%)] with a negative predictive value of 97.3% (95% CI 96.5-98.0) for GDM, while avoiding 52.2% OGTTs. Compared to GDM with FPG ≥ 78 mg/dL [187 (81.0%)], GDM women with FPG < 78 mg/dL had a significantly lower BMI (27.1 ± 4.5 vs. 29.6 ± 5.2 kg/m
2 , p = 0.003), less insulin resistance [Matsuda: 0.4 (0.4-0.7) vs. 0.3 (0.2-0.5), p < 0.001] and better β-cell function [ISSI-2: 0.13 (0.08-0.25) vs. 0.09 (0.04-0.15), p = 0.004]. Compared to NGT women (1612) with FPG ≥ 78 mg/dL [846 (52.5%)], NGT with FPG < 78 mg/dL [766 (47.5%)] had a significantly lower BMI (26.0 ± 3.9 vs. 27.8 ± 4.7 kg/m2 , p < 0.001), less insulin resistance [Matsuda: 0.7 (0.5-0.9) vs. 0.5 (0.4-0.7), p < 0.001], better β-cell function [ISSI-2: 0.17 (0.10-0.30) vs. 0.12 (0.07-0.21), p < 0.001], and less often large-for-gestational age infants [9.2 (70) vs. 16.2% (136), p < 0.001]., Conclusions: FPG < 78 mg/dL can be used to limit the number of OGTTs when screening for GDM. Women with FPG < 78 mg/dL had a better metabolic profile and in NGT women also less fetal overgrowth., (© 2021. Springer-Verlag Italia S.r.l., part of Springer Nature.)- Published
- 2022
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35. Relationship Between Time in Range, Glycemic Variability, HbA1c, and Complications in Adults With Type 1 Diabetes Mellitus.
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El Malahi A, Van Elsen M, Charleer S, Dirinck E, Ledeganck K, Keymeulen B, Crenier L, Radermecker R, Taes Y, Vercammen C, Nobels F, Mathieu C, Gillard P, and De Block C
- Subjects
- Adult, Blood Glucose drug effects, Diabetes Mellitus, Type 1 blood, Female, Follow-Up Studies, Glycated Hemoglobin analysis, Hospitalization statistics & numerical data, Humans, Hypoglycemia blood, Hypoglycemia etiology, Hypoglycemia therapy, Insulin adverse effects, Insulin Infusion Systems, Ketosis blood, Ketosis etiology, Ketosis therapy, Male, Middle Aged, Prospective Studies, Time Factors, Blood Glucose analysis, Hypoglycemia epidemiology, Insulin administration & dosage, Ketosis epidemiology, Monitoring, Physiologic statistics & numerical data
- Abstract
Purpose: Real-time continuous glucose monitoring (RT-CGM) provides information on glycemic variability (GV), time in range (TIR), and guidance to avoid hypoglycemia, thereby complimenting HbA1c for diabetes management. We investigated whether GV and TIR were independently associated with chronic and acute diabetes complications., Methods: Between September 2014 and January 2017, 515 subjects with type 1 diabetes using sensor-augmented pump therapy were followed for 24 months. The link between baseline HbA1c and CGM-derived glucometrics (TIR [70-180 mg/dL], coefficient of variation [CV], and SD) obtained from the first 2 weeks of RT-CGM use and the presence of complications was investigated. Complications were defined as: composite microvascular complications (presence of neuropathy, retinopathy, or nephropathy), macrovascular complications, and hospitalization for hypoglycemia and/or ketoacidosis., Results: Individuals with microvascular complications were older (P < 0.001), had a longer diabetes duration (P < 0.001), a higher HbA1c (7.8 ± 0.9 vs 7.5 ± 0.9%, P < 0.001), and spent less time in range (60.4 ± 12.2 vs 63.9 ± 13.8%, P = 0.022) compared with those without microvascular complication. Diabetes duration (odds ratio [OR] = 1.12 [1.09-1.15], P < 0.001) and TIR (OR = 0.97 [0.95-0.99], P = 0.005) were independent risk factors for composite microvascular complications, whereas SD and CV were not. Age (OR = 1.08 [1.03-1.14], P = 0.003) and HbA1c (OR = 1.80 [1.02-3.14], P = 0.044) were risk factors for macrovascular complications. TIR (OR = 0.97 [0.95-0.99], P = 0.021) was the only independent risk factor for hospitalizations for hypoglycemia or ketoacidosis., Conclusions: Lower TIR was associated with the presence of composite microvascular complications and with hospitalization for hypoglycemia or ketoacidosis. TIR, SD, and CV were not associated with macrovascular complications., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2022
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36. Lipohypertrophy Monitoring Study (LIMO): Effect of single use of 4 mm pen needles combined with education on injection site rotation on glycaemic control: Confirmation of an unpleasant truth.
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Bochanen N, Decochez K, Heleu E, Cuypers J, Vercammen C, Coremans P, Vanhaverbeke G, Shadid S, Keymeulen B, Bolsens N, and De Block C
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- Diabetes Mellitus, Type 1 blood, Female, Follow-Up Studies, Humans, Hypertrophy, Hypoglycemic Agents administration & dosage, Injections, Subcutaneous instrumentation, Male, Middle Aged, Prospective Studies, Time Factors, Blood Glucose metabolism, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 2 drug therapy, Glycemic Control standards, Insulin administration & dosage, Needles, Patient Education as Topic methods
- Abstract
Aims: To investigate whether single use of 4 mm needles combined with education about injection technique and lipohypertrophy affects HbA1c, hypoglycaemia and glucose variability., Methods: Insulin-injecting people with diabetes recruited from nine Belgian diabetes centres were prospectively followed for 6 months. They were provided 4 mm pen needles and education concerning injection technique using an online platform (BD and Me™) based on the international Forum for Injection Technique & Therapy Recommendations focused on avoidance of lipohypertrophy zones and reduction of needle reuse., Results: A total of 171 people with diabetes were included of which 146 completed the study. At baseline, lipohypertrophy was present in 63.0% of those who completed the study, with 51.4% injecting in zones of lipohypertrophy, 37.0% incorrectly rotating and 95.9% reusing needles. After the intervention, 7.5% still injected in a lipohypertrophy zone, 4.1% rotated incorrectly and needle reuse decreased to 21.2%. The number of participants with severe hypoglycaemias (from 15.8% to 4.1%, p < 0.001), unexplained hypoglycaemias (from 46.6% to 16.4%, p < 0.001) and high glucose variability (from 64.4% to 29.5%, p < 0.001) was significantly reduced. HbA1c and total daily insulin dose remained stable., Conclusion: The combination of 4 mm pen needles and online education on injection techniques significantly reduced the number of people with severe hypoglycaemic episodes, unexplained hypoglycaemia and high glucose variability but did not improve HbA1c control nor lower insulin needs., Trial Registration: ClinicalTrials.gov NCT04659330., (© 2021 Diabetes UK.)
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- 2022
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37. Preference of Women for Gestational Diabetes Screening Method According to Tolerance of Tests and Population Characteristics.
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Raets L, Vandewinkel M, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, and Benhalima K
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- Adult, Cohort Studies, Diabetes, Gestational psychology, Female, Glucose Tolerance Test methods, Glucose Tolerance Test psychology, Humans, Mass Screening psychology, Pregnancy, Prospective Studies, Blood Glucose metabolism, Diabetes, Gestational blood, Diabetes, Gestational diagnosis, Mass Screening methods, Patient Preference psychology, Population Surveillance methods
- Abstract
Aims: To determine the preferred method of screening for gestational diabetes mellitus (GDM)., Methods: 1804 women from a prospective study (NCT02036619) received a glucose challenge test (GCT) and 75g oral glucose tolerance test (OGTT) between 24-28 weeks. Tolerance of screening tests and preference for screening strategy (two-step screening strategy with GCT compared to one-step screening strategy with OGTT) were evaluated by a self-designed questionnaire at the time of the GCT and OGTT., Results: Compared to women who preferred one-step screening [26.2% (472)], women who preferred two-step screening [46.3% (834)] were less often from a minor ethnic background [6.0% (50) vs . 10.7% (50), p=0.003], had less often a previous history of GDM [7.3% (29) vs . 13.8% (32), p=0.008], were less often overweight or obese [respectively 23.1% (50) vs . 24.8% (116), p<0.001 and 7.9% (66) vs . 18.2% (85), p<0.001], were less insulin resistant in early pregnancy (HOMA-IR 8.9 (6.4-12.3) vs . 9.9 (7.2-14.2), p<0.001], and pregnancy outcomes were similar except for fewer labor inductions and emergency cesarean sections [respectively 26.6% (198) vs . 32.5% (137), p=0.031 and 8.2% (68) vs . 13.0% (61), p=0.005]. Women who preferred two-step screening had more often complaints of the OGTT compared to women who preferred one-step screening [50.4% (420) vs . 40.3% (190), p<0.001]., Conclusions: A two-step GDM screening involving a GCT and subsequent OGTT is the preferred GDM screening strategy. Women with a more adverse metabolic profile preferred one-step screening with OGTT while women preferring two-step screening had a better metabolic profile and more discomfort of the OGTT. The preference for the GDM screening method is in line with the recommended Flemish modified two-step screening method, in which women at higher risk for GDM are recommended a one-step screening strategy with an OGTT, while women without these risk factors, are offered a two-step screening strategy with GCT., Clinical Trial Registration: NCT02036619 https://clinicaltrials.gov/ct2/show/NCT02036619., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Raets, Vandewinkel, Van Crombrugge, Moyson, Verhaeghe, Vandeginste, Verlaenen, Vercammen, Maes, Dufraimont, Roggen, De Block, Jacquemyn, Mekahli, De Clippel, Van Den Bruel, Loccufier, Laenen, Devlieger, Mathieu and Benhalima.)
- Published
- 2021
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38. Antenatal Depression and Risk of Gestational Diabetes, Adverse Pregnancy Outcomes, and Postpartum Quality of Life.
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Minschart C, De Weerdt K, Elegeert A, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, and Benhalima K
- Subjects
- Adult, Blood Glucose, Depression psychology, Diabetes, Gestational psychology, Female, Glucose Tolerance Test, Humans, Pregnancy, Pregnancy Complications psychology, Prevalence, Prospective Studies, Risk, Surveys and Questionnaires, Depression epidemiology, Diabetes, Gestational epidemiology, Pregnancy Complications epidemiology, Pregnancy Outcome, Quality of Life psychology
- Abstract
Aims: To determine the impact of depressive symptoms on pregnancy outcomes and postpartum quality of life in women with gestational diabetes mellitus (GDM) and normal glucose tolerance (NGT)., Methods: 1843 women from a prospective cohort study received universal GDM screening with an oral glucose tolerance test (OGTT). The Center for Epidemiologic Studies-Depression questionnaire was completed before GDM diagnosis was communicated and in GDM women in early postpartum. All participants completed the 36-Item Short Form Health Survey (SF-36) health survey postpartum., Results: Women who developed GDM (231; 12.5%) had significantly more often depressive symptoms than NGT (1612; 87.5%) women [21.3% (48) vs 15.1% (239), odds ratio (OR) 1.52, 95% confidence interval (CI) (1.08-2.16), P = 0.017]. Compared to GDM women without depressive symptoms, depressed GDM women attended less often the postpartum OGTT [68.7% (33) vs 87.6% (155), P = 0.002], remained more often depressed [37.1% (13) vs 12.4% (19), P < 0.001], and had lower SF-36 scores postpartum. There were no significant differences in pregnancy outcomes between both groups. Rates of labor inductions were significantly higher in the NGT group with depressive symptoms compared to the nondepressed NGT group [31.7% (75) vs 24.7% (330), adjusted OR (aOR) 1.40, 95% CI (1.01-1.93), P = 0.041]. NGT women with depressive symptoms had lower SF-36 scores (P < 0.001) postpartum compared to nondepressed NGT women., Conclusions: Women with antenatal symptoms of depression develop more often GDM. GDM women with depressive symptoms remain more often depressed postpartum with lower quality of life. NGT women with depressive symptoms have higher rates of labor inductions and lower quality of life postpartum compared to nondepressed NGT women., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2021
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39. Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial.
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Visser MM, Charleer S, Fieuws S, De Block C, Hilbrands R, Van Huffel L, Maes T, Vanhaverbeke G, Dirinck E, Myngheer N, Vercammen C, Nobels F, Keymeulen B, Mathieu C, and Gillard P
- Subjects
- Adult, Belgium, Blood Glucose analysis, Female, Glycated Hemoglobin analysis, Humans, Insulin Infusion Systems, Male, Prospective Studies, Quality of Life, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia diagnosis, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Abstract
Background: People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1)., Methods: We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA
1c ), time in range (sensor glucose 3·9-10·0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600., Findings: Between Jan 29 and Jul 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59·6% vs 51·9%; mean difference 6·85 percentage points [95% CI 4·36-9·34]; p<0·0001). After 6 months HbA1c was lower (7·1% vs 7·4%; p<0·0001), as was time <3·0 mmol/L (0·47% vs 0·84%; p=0·0070), and Hypoglycaemia Fear Survey version II worry subscale score (15·4 vs 18·0; p=0·0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0·0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users., Interpretation: In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes., Funding: Dexcom., Competing Interests: Declaration of interests UZ Leuven received non-financial support for travel from Novo Nordisk for MMV. KU Leuven received non-financial support for travel from Medtronic, and financial support for travel from Roche for SC. CDB reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, A Menarini Diagnostics, Eli Lilly, Medtronic, Novo Nordisk, and Roche. RH serves or has served on the advisory panel for Merck Sharp and Dohme, Boehringer Ingelheim, and Eli Lilly. LVH reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Merck Sharp and Dohme, Novo Nordisk, and Sanofi-Aventis. GV serves or has served on the advisory panel for Merck Sharp and Dohme, Boehringer-Ingelheim, and Eli Lilly; reports consulting fees and honoraria for speaking from Merck Sharp and Dohme, Boehringer Ingelheim, AstraZenica, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. ED has served on the advisory panel for Novo Nordisk; ED reports speaking fees from Novo Nordisk, Boehringer-Ingelheim, Eli Lilly, and AstraZenica. NM serves or has served on the advisory panel for Boehringer-Ingelheim; and reports speaking fees from Merck Sharp and Dohme, Boehringer-Ingelheim, AstraZenica, Sanofi-Aventis, Novo Nordisk, and Eli Lilly. CV reports consulting and speaking fees from Medtronic, Boehringer Ingelheim, Astra Zeneca, and Sanofi Aventis. FN reports consulting fees and honoraria for speaking from Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Johnson and Johnson, Medtronic, Merck Sharp and Dohme, Novo Nordisk, Roche, and Sanofi-Aventis. CM serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, and Zealand Pharma (financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from Medtronic, Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Roche, Abbott, ActoBio Therapeutics, and Novartis); serves or has served on the speakers' bureau for Novo Nordisk, Sanofi-Aventis, Merck Sharp and Dohme, Eli Lilly, Boehringer Ingelheim, AstraZeneca, and Novartis (financial compensation for these activities has been received by KU Leuven). PG serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Boehringer-Ingelheim, Janssen Pharmaceuticals, Roche, Medtronic, and Bayer (financial compensation for these activities has been received by KU Leuven). PG serves or has served on the speakers bureau for Merck Sharp and Dohme, Boehringer-Ingelheim, Bayer, Medtronic, Insulet, Novo Nordisk, Abbott, and Roche (financial compensation for these activities has been received by KU Leuven and KU Leuven received for PG non-financial support for travel from Sanofi-Aventis, A Menarini Diagnostics, Medtronic, and Roche); and received a grant for a senior clinical research fellowship from Fonds Wetenschappelijk Onderzoek Flanders. SC received a doctoral grant for strategic basic research from Fonds Wetenschappelijk Onderzoek Flanders. All disclosures are unrelated to the present work. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)- Published
- 2021
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40. Predictors of neonatal adiposity and associations by fetal sex in women with gestational diabetes mellitus and normal glucose-tolerant women.
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Benhalima K, De Landtsheer A, Van Crombrugge P, Moyson C, Verhaeghe J, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Laenen A, Devlieger R, Minschart C, and Mathieu C
- Subjects
- Adolescent, Adult, Belgium epidemiology, Birth Weight physiology, C-Peptide analysis, C-Peptide blood, Cohort Studies, Diabetes, Gestational blood, Diabetes, Gestational epidemiology, Female, Fetal Blood chemistry, Fetal Blood metabolism, Fetal Macrosomia blood, Fetal Macrosomia epidemiology, Fetal Macrosomia etiology, Fetus metabolism, Humans, Infant, Newborn, Leptin analysis, Leptin blood, Lipids analysis, Lipids blood, Male, Middle Aged, Pregnancy, Pregnancy Outcome, Prognosis, Prospective Studies, Sex Characteristics, Skinfold Thickness, Young Adult, Adiposity physiology, Diabetes, Gestational diagnosis, Fetal Macrosomia diagnosis, Fetus physiology
- Abstract
Aims: To determine predictors of neonatal adiposity and differences in associations by fetal sex in women with gestational diabetes mellitus (GDM), normal-weight and overweight (BMI ≥ 25 kg/m
2 ) normal glucose-tolerant women (NGT)., Methods: Skinfold thickness was measured in 576 newborns, and cord blood leptin, c-peptide and lipids in 327 newborns in a multi-centric prospective cohort study., Results: Compared to neonates of normal-weight NGT women (327), neonates of women with GDM (97) were more often large-for-gestational age (LGA) (16.5% vs 8.6%, p = 0.024) ,but the macrosomia rate (8.2% vs 5.8%, p = 0.388), sum of skinfolds (13.9 mm ± 2.9 vs 13.3 mm ± 2.6, p = 0.067), neonatal fat mass (1333.0 g ± 166.8 vs 1307.3 g ± 160.9, p = 0.356), and cord blood biomarkers were not significantly different. Compared to neonates of normal-weight NGT women, neonates of overweight NGT women (152) had higher rates of macrosomia (12.5% vs 5.8%, p = 0.012), LGA (17.1% vs 8.6%, p = 0.006), higher sum of skinfolds (14.3 mm ± 2.6 vs 13.2 mm ± 2.6, p < 0.001), neonatal fat mass (1386.0 g ± 168.6 vs 1307.3 g ± 160.9, p < 0.001), % neonatal fat mass > 90th percentile (15.2% vs 7.1%, p < 0.001), without significant differences in cord blood biomarkers. Maternal BMI, fasting glycemia, triglycerides, gestational weight gain, cord blood leptin ,and cord blood triglycerides were independent predictors for neonatal adiposity. Gestational weight gain was positively associated with adiposity in boys only., Conclusion: Compared to neonates of normal-weight NGT women, neonates of GDM women have higher LGA rates but similar adiposity, while neonates of overweight NGT women have increased adiposity. Limiting gestational weight gain might be especially important in the male fetus to reduce neonatal adiposity.- Published
- 2021
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41. Women with Mild Fasting Hyperglycemia in Early Pregnancy Have More Neonatal Intensive Care Admissions.
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Benhalima K, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Minschart C, Devlieger R, and Mathieu C
- Subjects
- Adult, Blood Glucose analysis, COVID-19, Female, Gestational Age, Glucose Tolerance Test, Humans, Hyperglycemia diagnosis, Hyperglycemia epidemiology, Infant, Newborn, Infant, Newborn, Diseases epidemiology, Infant, Newborn, Diseases etiology, Infant, Newborn, Diseases therapy, Pandemics, Pregnancy, Pregnancy Complications diagnosis, Pregnancy Complications epidemiology, Pregnancy Outcome epidemiology, Prenatal Exposure Delayed Effects blood, Prenatal Exposure Delayed Effects epidemiology, Prenatal Exposure Delayed Effects therapy, Prospective Studies, Risk Factors, SARS-CoV-2, Severity of Illness Index, Young Adult, Fasting blood, Hyperglycemia blood, Intensive Care, Neonatal statistics & numerical data, Patient Admission statistics & numerical data, Pregnancy Complications blood
- Abstract
Aims: To determine impact of mild fasting hyperglycemia in early pregnancy (fasting plasma glucose [FPG] 5.1-5.5 mmol/L) on pregnancy outcomes., Methods: We measured FPG at 11.9 ± 1.8 weeks in 2006 women from a prospective cohort study. Women with FPG ≥5.6 mmol/L (19) received treatment and were excluded from further analyses. A total of 1838 women with FPG <5.6 mmol/L received a 75 g oral glucose tolerance test (OGTT) between 24 and 28 weeks of pregnancy., Results: Of all participants, 78 (4.2%) had FPG 5.1 to 5.5 mmol/L in early pregnancy, of which 49 had a normal OGTT later in pregnancy (high fasting normal glucose tolerance [NGT] group). Compared with the NGT group with FPG <5.1 mmol/L in early pregnancy (low fasting NGT group, n = 1560), the high fasting NGT group had a higher body mass index (BMI), higher insulin resistance with more impaired insulin secretion and higher FPG and 30 minute glucose levels on the OGTT. The admission rate to neonatal intensive care unit (NICU) was significantly higher in the high fasting NGT group than in the low fasting NGT group (20.4% [10] vs 9.3% [143], P = .009), with no difference in duration (7.0 ± 8.6 vs 8.4 ± 14.3 days, P = .849) or indication for NICU admission between both groups. The admission rate to NICU remained significantly higher (odds ratio 2.47; 95% confidence interval 1.18-5.19, P = .017) after adjustment for age, BMI, and glucose levels at the OGTT., Conclusions: When provision of an OGTT is limited such as in the Covid-19 pandemic, using FPG in early pregnancy could be an easy alternative to determine who is at increased risk for adverse pregnancy outcomes., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2021
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42. Changing the narrative for hearing health in the broader context of healthy living: a call to action.
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Saunders GH, Vercammen C, Timmer BHB, Singh G, Pelosi A, Meis M, Launer S, Kramer SE, Gagné JP, and Bott A
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- Audiologists, Healthy Lifestyle, Hearing, Humans, Audiology, Quality of Life
- Abstract
Objective: To discuss the steps necessary to facilitate hearing health care in the context of well-being and healthy living., Design: Common themes among the articles in this special supplement of the International Journal of Audiology were used to identify issues that must be addressed if audiology is to move from being hearing-focussed to taking a holistic perspective of hearing care in the context of healthy aging. These are discussed within the context of other published literature., Results and Conclusions: Three needs were identified: (i) Increased interdisciplinary education to raise awareness of the interplay between hearing and health. (ii) Increased emphasis on counselling education in audiology programs so that audiologists are equipped with the knowledge, competence and confidence to provide counselling and emotional support to their patients, beyond care. (iii) Redefinition of therapeutic goal setting and hearing outcomes to include aspects of well-being, so that audiologists can capture and patients realise that that good hearing outcomes can have a direct positive impact on a person's quality of life that extends beyond their improved ability to hear. It was emphasised that each of these needs to be considered within the context of the audiologists' scope of practice and audiologists' well-being.
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- 2021
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43. Hearing health in the broader context of healthy living and well-being: changing the narrative.
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Vercammen C, Bott A, and Saunders GH
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- Healthy Lifestyle, Hearing Tests, Humans, Hearing, Narration
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- 2021
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44. Screening and follow-up of pregestational diabetes and gestational diabetes mellitus: A survey of primary care physicians in Belgium.
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Vercammen E, Van Hoof L, Vercammen C, Goderis G, and Benhalima K
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- Belgium epidemiology, Female, Follow-Up Studies, Humans, Mass Screening, Pregnancy, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 epidemiology, Diabetes, Gestational diagnosis, Diabetes, Gestational epidemiology, Diabetes, Gestational therapy, Physicians, Primary Care
- Abstract
Aims: Consensus regarding the best screening and follow-up strategy for gestational diabetes mellitus (GDM) is lacking, resulting in heterogeneity in clinical practice. We aimed to evaluate screening and follow-up practices for pregestational type 2 diabetes (T2DM) and GDM in primary care in Belgium., Methods: We performed an online survey among primary care physicians (PCPs) in the northern part of Belgium, Flanders., Results: Responses were obtained from 379 PCPs. Approximately two thirds of participants estimated the prevalence of pregestational T2DM and GDM in Flanders at 5% and <10%, respectively. The risk of developing T2DM within 10 years after a history of GDM was estimated at <30% by nearly half of all participants. The majority of interviewed PCPs screen for pre-existing T2DM and GDM. For T2DM, fasting glycaemia was used by 92.2% whereas for GDM, 75.2% used the 50g glucose challenge test (GCT). Fasting glycaemia was the preferred test for postpartum follow-up., Conclusions: While overall guideline adherence appears favourable, the prevalence of GDM is underestimated. Increased awareness on the long-term risk for women with a history of GDM is needed. The overall preference for the two-step strategy with GCT indicates that the 2019 Flemish guidelines on GDM screening are attainable in primary care., (Copyright © 2020 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2020
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45. Sustained Impact of Real-time Continuous Glucose Monitoring in Adults With Type 1 Diabetes on Insulin Pump Therapy: Results After the 24-Month RESCUE Study.
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Charleer S, De Block C, Nobels F, Radermecker RP, Lowyck I, Mullens A, Scarnière D, Spincemaille K, Strivay M, Weber E, Taes Y, Vercammen C, Keymeulen B, Mathieu C, and Gillard P
- Subjects
- Adult, Blood Glucose drug effects, Blood Glucose metabolism, Blood Glucose Self-Monitoring methods, Cohort Studies, Diabetes Mellitus, Type 1 epidemiology, Diabetes Mellitus, Type 1 psychology, Fear physiology, Female, Glycated Hemoglobin analysis, Glycated Hemoglobin drug effects, Humans, Hyperglycemia blood, Hyperglycemia drug therapy, Hyperglycemia epidemiology, Hypoglycemia chemically induced, Hypoglycemia epidemiology, Hypoglycemia psychology, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Insulin adverse effects, Male, Middle Aged, Prospective Studies, Quality of Life, Surveys and Questionnaires, Time Factors, Young Adult, Blood Glucose analysis, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 drug therapy, Insulin administration & dosage, Insulin Infusion Systems adverse effects
- Abstract
Objective: In recent years, a growing number of people with type 1 diabetes gained access to real-time continuous glucose monitoring (rtCGM). Long-term benefits of rtCGM are unclear because of a lack of large studies of long duration. We evaluated whether real-world rtCGM use up to 24 months offered benefits, particularly in those living with impaired awareness of hypoglycemia (IAH)., Research Design and Methods: This 24-month, prospective, observational cohort study followed 441 adults with insulin pumps receiving full reimbursement for rtCGM. Forty-two percent had IAH. The primary end point was evolution of HbA
1c , with secondary end points change in acute hypoglycemia complications, diabetes-related work absenteeism, and quality of life scores. Additionally, we evaluated whether people could achieve glycemic consensus targets during follow-up., Results: After 24 months, HbA1c remained significantly lower compared with baseline (7.64% [60 mmol/mol] vs. 7.37% [57 mmol/mol], P < 0.0001). Sustained benefits were also observed for the score on the hypoglycemia fear survey and hypoglycemia-related acute complications irrespective of hypoglycemia awareness level. People with IAH had the strongest improvement, especially for severe hypoglycemia (862 events in the year before vs. 119 events per 100 patient-years in the 2nd year, P < 0.0001). Over 24 months, more people were able to meet hypoglycemia consensus targets at the expense of slightly fewer people achieving hyperglycemia consensus targets. Furthermore, the number of people with HbA1c <7% (<53 mmol/mol) without severe hypoglycemia events more than doubled (11.0% vs. 25.4%, P < 0.0001)., Conclusions: Use of rtCGM led to sustained improvements in hypoglycemia-related glucose control over 24 months. Lower fear of hypoglycemia, fewer acute hypoglycemia-related events, and fewer diabetes-related days off from work were observed, particularly in those with IAH., (© 2020 by the American Diabetes Association.)- Published
- 2020
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46. The 2019 Flemish consensus on screening for overt diabetes in early pregnancy and screening for gestational diabetes mellitus.
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Benhalima K, Minschart C, Van Crombrugge P, Calewaert P, Verhaeghe J, Vandamme S, Theetaert K, Devlieger R, Pierssens L, Ryckeghem H, Dufraimont E, Vercammen C, Debie A, De Block C, Vandenberghe G, Van Imschoot S, Verstraete S, Buyse L, Wens J, Muyldermans J, Meskal A, De Spiegeleer S, and Mathieu C
- Subjects
- Bariatric Surgery, Belgium, Counseling, Diabetes Mellitus, Type 1 diagnosis, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 2 therapy, Diabetes, Gestational therapy, Fasting, Female, Glucose Tolerance Test, Humans, Mass Screening, Obesity, Maternal, Preconception Care methods, Preconception Care standards, Pregnancy, Pregnancy Trimester, First, Pregnancy in Diabetics therapy, Prenatal Care methods, Prenatal Care standards, Societies, Medical, Diabetes Mellitus, Type 2 diagnosis, Diabetes, Gestational diagnosis, Pregnancy in Diabetics diagnosis
- Abstract
Screening for gestational diabetes mellitus (GDM) is important to improve pregnancy outcomes and to prevent type 2 diabetes after pregnancy. The 'International Association of Diabetes and Pregnancy Study Groups' (IADPSG) recommends a universal one-step approach with the 75 g oral glucose tolerance test (OGTT) for screening of GDM. The IADPSG recommendation remains controversial due to the important increase in GDM prevalence and increased workload. After review of the latest evidence and based on data from the 'Belgian Diabetes in Pregnancy' study, members of the Diabetes Liga, the Flemish associations of general physicians (Domus Medica), obstetricians (VVOG), midwives (VVOB), diabetes nurse educators (BVVDV) and clinical chemists (RBSLM) have reached a new consensus on screening for GDM in Flanders. This new consensus recommends universal screening for overt diabetes when planning pregnancy or at the latest at first prenatal contact, preferably by measuring the fasting plasma glucose by using the same diagnostic criteria as in the non-pregnant state. In women with impaired fasting glycaemia, but also in normoglycemic obese women and women with a previous history of GDM, lifestyle counselling is advised with screening for GDM with a 75 g OGTT at 24 weeks. In all other women, we recommend a two-step screening strategy with a 50 g glucose challenge test (GCT) at 24 weeks followed by a 75 g OGTT when the glucose level 1 hour after the GCT ≥130 mg/dl. Diagnosis of GDM is made using the IADPSG criteria for GDM. Postpartum screening for subsequent glucose abnormalities should be advocated and organized for every woman with GDM.
- Published
- 2020
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47. Estimating the risk of gestational diabetes mellitus based on the 2013 WHO criteria: a prediction model based on clinical and biochemical variables in early pregnancy.
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Benhalima K, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Minschart C, Devlieger R, and Mathieu C
- Subjects
- Adult, Belgium epidemiology, Biomarkers blood, Blood Glucose analysis, Blood Glucose metabolism, Body Mass Index, Cohort Studies, Diabetes, Gestational blood, Diabetes, Gestational epidemiology, Female, Gestational Age, Glucose Tolerance Test, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Humans, Pregnancy, Pregnancy Trimester, First blood, Prenatal Diagnosis standards, Prognosis, Prospective Studies, Risk Factors, Triglycerides blood, World Health Organization, Young Adult, Biomarkers analysis, Diabetes, Gestational diagnosis, Diabetes, Gestational etiology, Models, Statistical, Prenatal Diagnosis methods
- Abstract
Aims: We aimed to develop a prediction model based on clinical and biochemical variables for gestational diabetes mellitus (GDM) based on the 2013 World Health Organization (WHO) criteria., Methods: A total of 1843 women from a Belgian multi-centric prospective cohort study underwent universal screening for GDM. Using multivariable logistic regression analysis, a model to predict GDM was developed based on variables from early pregnancy. The performance of the model was assessed by receiver-operating characteristic (AUC) analysis. To account for over-optimism, an eightfold cross-validation was performed. The accuracy was compared with two validated models (van Leeuwen and Teede)., Results: A history with a first degree relative with diabetes, a history of smoking before pregnancy, a history of GDM, Asian origin, age, height and BMI were independent predictors for GDM with an AUC of 0.72 [95% confidence interval (CI) 0.69-0.76)]; after cross-validation, the AUC was 0.68 (95% CI 0.64-0.72). Adding biochemical variables, a history of a first degree relative with diabetes, a history of GDM, non-Caucasian origin, age, height, weight, fasting plasma glucose, triglycerides and HbA
1c were independent predictors for GDM, with an AUC of the model of 0.76 (95% CI 0.72-0.79); after cross-validation, the AUC was 0.72 (95% CI 0.66-0.78), compared to an AUC of 0.67 (95% CI 0.63-0.71) using the van Leeuwen model and an AUC of 0.66 (95% CI 0.62-0.70) using the Teede model., Conclusions: A model based on easy to use variables in early pregnancy has a moderate accuracy to predict GDM based on the 2013 WHO criteria.- Published
- 2020
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48. Characteristics and pregnancy outcomes across gestational diabetes mellitus subtypes based on insulin resistance.
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Benhalima K, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Minschart C, Devlieger R, and Mathieu C
- Subjects
- Belgium, Blood Glucose metabolism, Cesarean Section, Cholesterol, LDL blood, Female, Glucose Intolerance metabolism, Glucose Tolerance Test, Humans, Hyperglycemia pathology, Insulin metabolism, Phenotype, Postpartum Period, Pregnancy, Prospective Studies, Triglycerides blood, Diabetes, Gestational blood, Diabetes, Gestational diagnosis, Insulin Resistance, Pregnancy Outcome
- Abstract
Aims/hypothesis: This study aimed to determine the characteristics and pregnancy outcomes across different subtypes of gestational diabetes mellitus (GDM) based on insulin resistance., Methods: GDM subtypes were defined in 1813 pregnant women from a multicentre prospective cohort study, stratified according to insulin resistance, based on Matsuda index below the 50th percentile of women with normal glucose tolerance (NGT), during a 75 g OGTT at 24-28 weeks' gestation. GDM was diagnosed in 12.4% (n = 228) of all participants based on the 2013 WHO criteria., Results: Compared with women with NGT (1113 [61.4%] of the total cohort) and insulin-sensitive women with GDM (39 [17.1%] women with GDM), women with GDM and high insulin resistance (189 [82.9%] women with GDM) had a significantly higher BMI, systolic BP, fasting plasma glucose (FPG), fasting total cholesterol, LDL-cholesterol and triacylglycerol levels in early pregnancy. Compared with women with NGT, insulin-sensitive women with GDM had a significantly lower BMI but similar BP, FPG and fasting lipid levels in early pregnancy. Compared with women with NGT, women with GDM and high insulin resistance had higher rates of preterm delivery (8.5% vs 4.7%, p = 0.030), labour induction (42.7% vs 28.1%, p < 0.001), Caesarean section (total Caesarean sections: 28.7% vs 19.4%, p = 0.004; emergency Caesarean sections: 16.0% vs 9.7%, p = 0.010), neonatal hypoglycaemia (15.4% vs 3.5%, p < 0.001) and neonatal intensive care unit admissions (16.0% vs 8.9%, p = 0.003). In multivariable logistic regression analyses using different models to adjust for demographics, BMI, FPG, HbA
1c , lipid levels and gestational weight gain in early pregnancy, preterm delivery (OR 2.41 [95% CI 1.08, 5.38]) and neonatal hypoglycaemia (OR 4.86 [95% CI 2.04, 11.53]) remained significantly higher in women with GDM and high insulin resistance compared with women with NGT. Insulin-sensitive women with GDM had similar pregnancy outcomes as women with NGT. The need for insulin treatment during pregnancy and the rate of glucose intolerance in the early postpartum period were not significantly different among the GDM subtypes., Conclusions/interpretation: GDM with high insulin resistance represents a more adverse metabolic profile with a greater risk of adverse pregnancy outcomes.- Published
- 2019
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49. Risk factor screening for gestational diabetes mellitus based on the 2013 WHO criteria
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Benhalima K, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Minschart C, Devlieger R, and Mathieu C
- Subjects
- Adult, Diabetes, Gestational blood, Europe epidemiology, Female, Glucose Tolerance Test standards, Humans, Pregnancy, Retrospective Studies, Risk Factors, Body Mass Index, Diabetes, Gestational diagnosis, Diabetes, Gestational epidemiology, Maternal Age, World Health Organization
- Abstract
Objective: Since many European countries use risk factor screening for gestational diabetes mellitus (GDM), we aimed to determine the performance of selective screening for GDM based on the 2013 WHO criteria., Design and Methods: Overall, 1811 women received universal screening with a 75 g oral glucose tolerance test (OGTT) with GDM in 12.5% (n = 231) women based on the 2013 WHO criteria. We retrospectively applied different European selective screening guidelines to this cohort and evaluated the performance of different clinical risk factors to screen for GDM., Results: By retrospectively applying the English, Irish, French and Dutch guidelines for selective screening, respectively 28.5% (n = 526), 49.7% (n = 916), 48.5% (n = 894) and 50.7% (n = 935) had at least one risk factor, with GDM prevalence of respectively 6.5% (n = 120), 7.9% (n = 146), 8.0% (n = 147) and 8.4% (n = 154). Using maternal age ≥30 and/or BMI ≥25 for screening, positive rate was 69.9% (n = 1288), GDM prevalence 10.2% (n = 188), sensitivity 81.4% (CI: 75.8–86.2%) and specificity 31.8% (CI: 29.5–34.1%). Adding other clinical risk factors did not improve detection. GDM women without risk factors had more neonatal hypoglycemia (14.4 vs 4.0%, P = 0.001) and labor inductions (39.7 vs 25.9%, P = 0.020) than normal-glucose tolerant women, and less cesarean sections than GDM women with risk factors (13.8 vs 31.0%, P = 0.010)., Conclusions: By applying selective screening by European guidelines, about 50% of women would need an OGTT with the lowest number of missed cases (33%) by the Dutch guidelines. Screening with age ≥30 years and/or BMI ≥25, reduced the number of missed cases to 18.6% but 70% would need an OGTT., (© 2019 European Society of Endocrinology)
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- 2019
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50. Prediction of Glucose Intolerance in Early Postpartum in Women with Gestational Diabetes Mellitus Based on the 2013 WHO Criteria.
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Benhalima K, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Minschart C, Devlieger R, and Mathieu C
- Abstract
Predictors for glucose intolerance postpartum were evaluated in women with gestational diabetes mellitus (GDM) based on the 2013 World Health Organization (WHO) criteria. 1841 women were tested for GDM in a prospective cohort study. A postpartum 75g oral glucose tolerance test (OGTT) was performed in women with GDM at 14 ± 4.1 weeks. Of all 231 mothers with GDM, 83.1% (192) had a postpartum OGTT of which 18.2% (35) had glucose intolerance. Women with glucose intolerance were more often of Asian origin [15.1% vs. 3.7%, OR 4.64 (1.26⁻17.12)], had more often a recurrent history of GDM [41.7% vs. 26.7%, OR 3.68 (1.37⁻9.87)], higher fasting glycaemia (FPG) [5.1 (4.5⁻5.3) vs. 4.6 (4.3⁻5.1) mmol/L, OR 1.05 (1.01⁻1.09)], higher HbA1c [33 (31⁻36) vs. 32 (30⁻33) mmol/mol, OR 4.89 (1.61⁻14.82)], and higher triglycerides [2.2 (1.9⁻2.8) vs. 2.0 (1.6⁻2.5) mmol/L, OR 1.00 (1.00⁻1.01)]. Sensitivity of glucose challenge test (GCT) ≥7.2 mmol/l for glucose intolerance postpartum was 80% (63.1%⁻91.6%). The area under the curve to predict glucose intolerance was 0.76 (0.65⁻0.87) for FPG, 0.54 (0.43⁻0.65) for HbA1c and 0.75 (0.64⁻0.86) for both combined. In conclusion, nearly one-fifth of women with GDM have glucose intolerance postpartum. A GCT ≥7.2 mmol/L identifies a high risk population for glucose intolerance postpartum.
- Published
- 2019
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