12 results on '"Minga, T"'
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2. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis
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Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS., Evolve Team, Chertow G, Parfrey P, Block G, Drüeke T, Goodman W, Herzog C, London G, Mahaffey K, Moe S, Wheeler D, Hennekens C, Baigent C, Brown W, O'Brien P, Anderson S, Hoel J, Szczech L, Patel U, Wampole J, Pun P, Felker M, Inrig J, Shah S, Hernandez A, Patel C, Brennan M, Albizem M, Capper E, Cauchi L, Cheng S, Dehmel B, Dhami K, Durham C, Francioni M, Gadd S, Goodman B, Guimaraes L, Grey N, Hamlin R, Harris C, Harris E, Heavey S, Heiges T, Heiser D, Jaeger P, James M, James P, Karimi S, Kewalramani R, Kraszewski A, Liang J, Maguire J, McCormick K, McFarlane K, Mix C, Modafferi D, Prathikanti R, Ryan C, Santiago N, Schumacher J, Seder C, Shahinfar S, Soares B, Stolman D, Tisher C, Trotman M, Tseng S, Ulias G, Unger P, Vyshenskaya A, Walsh L, White C, Wilde K, Santos J, Zarazaga C, Marin I, Garrote N, Cusumano A, Penalba N, Del Valle E, Juncos L, Saye J, Lef L, Altobelli V, Petraglia G, Rosa-Diez G, Douthat W, Lobo J, Gallart C, Lafalla A, Diez G, Linares B, Lopez N, Ramirez N, Gonzalez R, Valtuille R, Beresan H, Hermida O, Rudolf G, Marchetta N, Rano M, Ramirez M, Garcia N, Gillies A, Jones B, Pedagogos E, Walker R, Talaulikar G, Bannister K, Suranyi M, Kark A, Roger S, Kerr P, Disney A, Mount P, Fraenkel M, Mathew M, Fassett R, Jose M, Hawley C, Lonergan M, Mackie J, Ferrari P, Menahem S, Sabto J, Hutchison B, Langham R, Pollock C, Holzer H, Oberbauer R, Arias I, Graf H, Mayer G, Lhotta K, Neyer U, Klauser-Braun R, Hoerl W, Horn S, Kovarik J, Kramar R, Eigner M, Dhaene M, Billiouw J, De Meester J, Warling X, Cambier-Dwelschauwers P, Evenepoel P, Daelemans R, Dratwa M, Maes B, Stolear J, Dejagere T, Vanwalleghem J, Bouman K, Jadoul M, Peeters J, Vanholder R, Tielemans C, Donck J, Almeida F, de Oliveira J, Burdmann E, Garcia V, Thome F, Deboni L, Bregman R, Lugon J, Araújo S, Ferreira Filho S, Daher Ede F, Baptista M, Carvalho A, d'Avila D, Moyses Neto M, Yu L, Bastos M, Lacativa P, Jorgetti V, Romão Ede A, da Costa JC, Pecoits Filho R, Gordan P, Salgado N, Araújo M, Coelho S, Oliveira I, Moysés R, Vasconcellos L, Batista P, Gross J, Pedrosa A, Cournoyer S, LeBlanc M, Chow S, Karunakaran S, Wong G, Tobe S, Desmeules S, Zimmerman D, Murphy S, Montambault P, Donnelly S, MacRae J, Culleton B, Soroka S, Rabbat C, Jindal K, Vasilevsky M, Michaud M, Wijeyesinghe E, Zacharias J, Lok C, Muirhead N, Verrelli M, Da Roza G, Sapir D, Olgaard K, Daugaard H, Brandi L, Jensen P, Boulechfar H, Ang K, Simon P, Rieu P, Brunet P, Touchard G, Torres P, Combe C, Durrbach A, Ortiz J, Hannedouche T, Vela C, Lionet A, Ryckelynck P, Zaoui P, Choukroun G, Fessi H, Lang P, Stroumza P, Joly D, Mousson C, Laville M, Dellanna F, Erley C, Braun J, Rambausek M, Riegel W, Klingberg M, Schwertfeger E, Wizemann V, Eckardt K, Reichel H, Passauer J, Hübel E, Frischmuth N, Liebl R, Fiedler R, Schwenger V, Voßkühler A, Kunzendorf U, Renders L, Rattensberger D, Rump L, Ketteler M, Neumayer H, Zantvoort F, Stahl R, Ladanyi E, Braun B, Kulcsar I, Mezei I, Csiky B, Rikker C, Arkossy O, Berta K, Szegedi J, Major L, Ferenczi S, Fekete A, Szabo T, Zakar G, Wagner G, Erdelyine S, Borbas B, Eustace J, Reddan D, Capasso G, Locatelli F, Villa G, Cozzolino M, Brancaccio D, Messa P, Bolasco P, Ricciardi B, Malberti F, Moriero E, Cannella G, Ortalda V, Stefoni S, Frascà G, Cappelli G, Albertazzi A, Zoccali C, Farina M, Elli A, Avella F, Ondei P, Mingardi G, Errico R, Losito A, Di Giulio S, Pertosa G, Schena F, Grandaliano G, Gesualdo L, Auricchio M, Bochicchio-Ricardelli T, Correa-Rotter J, Verástegui F, Peña J, Wong A, Cruz-Valdez J, Zamora M, Solis M, Diaz M, Flores M, Sandoval E, van den Dorpel M, Brink H, Van Kuijk W, Vermeij C, Gregoor P, Hagen E, van der Sande F, Klinger M, Nowicki M, Muszytowski M, Bidas K, Bentkowski W, Wiecek A, Ksiazek A, Marczewski K, Ostrowski M, Switalski M, Sulowicz W, Matuszkiewicz-Rowinska J, Mysliwiec M, Durlik M, Rutkowski B, Macario F, Carvalho B, Frazao J, Machado D, Weigert A, Andrusev A, Khrustalev O, Zemtchenkov A, Gurevich K, Staroselsky K, Khadikova N, Rozhinskaya L, Timokhovskaya G, Strokov A, Balkarova O, Ermolenko V, Kolmakova E, Komandenko M, Timofeev M, Shilo V, Shostka G, Smirnov A, Anashkin V, Volgina G, Domashenko O, Gurevich A, Perlin D, García J, Ribes E, Piera E, Lucas M, Galicia M, Prados M, González M, Romero R, de Francisco ÁM, Montenegro J, Santiago C, García F, de La Ossa J, Arrieta J, Pons J, Martín-Malo A, Amigó J, Cases A, Sterner G, Jensen G, Wikström B, Jacobson S, Lund U, Weiss L, Ståhl A, von Albertini B, Burnier M, Meier P, Martin P, Uehlinger D, Dickenmann M, Yaqoob M, Zehnder D, Kalra P, Padmanabhan N, Roe S, Eadington D, Pritchard N, Hutchison A, Davies S, Wilkie M, Davies M, Pai P, Swift P, Kwan J, Goldsmith D, Tomson C, Stratton J, Dasgupta I, Sarkar S, Moustafa M, Gandhi K, Jamal A, Galindo-Ramos E, Tuazon J, Batlle D, Tucker K, Schiller-Moran B, Assefi A, Martinez C, Samuels L, Goldman J, Cangiano-Rivera J, Darwish R, Lee M, Topf J, Kapatkin K, Baer H, Kopelman R, Acharya M, Tharpe D, Bernardo M, Nader P, Guzman-Rivera J, Pergola P, Sekkarie M, Alas E, Zager P, Liss K, Navarro J, Roppolo M, Denu-Ciocca C, Kshirsagar A, El Khatib M, Kant K, Scott D, Murthyr B, Finkelstein F, Keightley G, McCrary R, Pitone J, Cavalieri T, Tsang A, Pellegrino B, Schmidt R, Ahmad S, Brown C, Friedman E, Mittman N, Fadem S, Shapiro W, Reddy M, Goldberger S, Woredekal Y, Agarwal A, Anger M, Haque M, Chidester P, Kohli R, Rubinstein S, Newman G, Gladish R, Ayodeji O, Soman S, Sprague S, Hunt N, Gehr T, Rizk D, Warnock D, Polack D, Pahl M, Fischer D, Dreyer P, James G, Husserl F, Rogers T, Raff A, Sedor J, Silver M, Smith M, Steinberg S, DelGiorno T, Jones E, Cunha P, Cheng J, Pogue V, Blumenthal S, Brown E, Charytan C, Buerkert J, Cook M, Felsenfeld A, Tareen N, Gupta A, Herman T, Diamond S, Hura C, Laski M, MacLaurin J, Plumb T, Brosnahan G, Kumar J, Henriquez M, Poole C, Osanloo E, Matalon A, Sholer C, Arfeen S, Azer M, Belledonne M, Gross M, Dunnigan E, McConnell K, Becker B, Rigolosi R, Spiegel D, Stegman M, Patak R, Streja D, Ranjit U, Youell T, Wooldridge T, Stafford C, Cottiero R, Weinberg M, Schonefeld M, Shahmir E, Hazzan A, Ashfaq A, Bhandari K, Cleveland W, Culpepper M, Golden J, Lai L, Lien Y, Lorica V, Robertson J, Malireddi K, Morse S, Thakur V, Israelit A, Raguram P, Alfred H, Weise W, Al-Saghir F, El Shahawy M, Rastogi A, Nissenson A, Kopyt N, Lynn R, Lea J, McClellan W, Teredesai P, Ong S, Tolkan S, Sugihara J, Minga T, Mehrotra R, Minasian R, Bhatia D, Specter R, Capelli J, Sidhu P, Dalal S, Dykes P, Khan M, Rahim F, Saklayen M, Thomas A, Michael B, Torres M, Al-Bander H, Murray B, Abukurah A, Gupta B, Nosrati S, Raja R, Zeig S, Braun M, Amatya A, Endsley J, Sharon Z, Dolson G, Dumler F, Ntoso K, Rosansky S, Kumar N, Gura V, Thompson N, Goldfarb D, Halligan R, Middleton J, Widerhorn A, Arbeit L, Arruda J, Crouch T, Friedman L, Khokhar S, Mittleman J, Light P, Taparia B, West C, Cotton J, Dhingra R, Kleinman L, Arif F, Lew S, Nammour T, Sterrett J, Williams M, Ramirez J, Rubin J, McCarthy J, Noble S, Chaffin M, Rekhi A., Chertow, Gm, Block, Ga, Correa-Rotter, R, Drüeke, Tb, Floege, J, Goodman, Wg, Herzog, Ca, Kubo, Y, London, Gm, Mahaffey, Kw, Mix, Tc, Moe, Sm, Trotman, Ml, Wheeler, Dc, Parfrey, Ps., Evolve, Team, Chertow, G, Parfrey, P, Block, G, Drüeke, T, Goodman, W, Herzog, C, London, G, Mahaffey, K, Moe, S, Wheeler, D, Hennekens, C, Baigent, C, Brown, W, O'Brien, P, Anderson, S, Hoel, J, Szczech, L, Patel, U, Wampole, J, Pun, P, Felker, M, Inrig, J, Shah, S, Hernandez, A, Patel, C, Brennan, M, Albizem, M, Capper, E, Cauchi, L, Cheng, S, Dehmel, B, Dhami, K, Durham, C, Francioni, M, Gadd, S, Goodman, B, Guimaraes, L, Grey, N, Hamlin, R, Harris, C, Harris, E, Heavey, S, Heiges, T, Heiser, D, Jaeger, P, James, M, James, P, Karimi, S, Kewalramani, R, Kraszewski, A, Liang, J, Maguire, J, Mccormick, K, Mcfarlane, K, Mix, C, Modafferi, D, Prathikanti, R, Ryan, C, Santiago, N, Schumacher, J, Seder, C, Shahinfar, S, Soares, B, Stolman, D, Tisher, C, Trotman, M, Tseng, S, Ulias, G, Unger, P, Vyshenskaya, A, Walsh, L, White, C, Wilde, K, Santos, J, Zarazaga, C, Marin, I, Garrote, N, Cusumano, A, Penalba, N, Del Valle, E, Juncos, L, Saye, J, Lef, L, Altobelli, V, Petraglia, G, Rosa-Diez, G, Douthat, W, Lobo, J, Gallart, C, Lafalla, A, Diez, G, Linares, B, Lopez, N, Ramirez, N, Gonzalez, R, Valtuille, R, Beresan, H, Hermida, O, Rudolf, G, Marchetta, N, Rano, M, Ramirez, M, Garcia, N, Gillies, A, Jones, B, Pedagogos, E, Walker, R, Talaulikar, G, Bannister, K, Suranyi, M, Kark, A, Roger, S, Kerr, P, Disney, A, Mount, P, Fraenkel, M, Mathew, M, Fassett, R, Jose, M, Hawley, C, Lonergan, M, Mackie, J, Ferrari, P, Menahem, S, Sabto, J, Hutchison, B, Langham, R, Pollock, C, Holzer, H, Oberbauer, R, Arias, I, Graf, H, Mayer, G, Lhotta, K, Neyer, U, Klauser-Braun, R, Hoerl, W, Horn, S, Kovarik, J, Kramar, R, Eigner, M, Dhaene, M, Billiouw, J, De Meester, J, Warling, X, Cambier-Dwelschauwers, P, Evenepoel, P, Daelemans, R, Dratwa, M, Maes, B, Stolear, J, Dejagere, T, Vanwalleghem, J, Bouman, K, Jadoul, M, Peeters, J, Vanholder, R, Tielemans, C, Donck, J, Almeida, F, de Oliveira, J, Burdmann, E, Garcia, V, Thome, F, Deboni, L, Bregman, R, Lugon, J, Araújo, S, Ferreira Filho, S, Daher Ede, F, Baptista, M, Carvalho, A, D'Avila, D, Moyses Neto, M, Yu, L, Bastos, M, Lacativa, P, Jorgetti, V, Romão Ede, A, da Costa, Jc, Pecoits Filho, R, Gordan, P, Salgado, N, Araújo, M, Coelho, S, Oliveira, I, Moysés, R, Vasconcellos, L, Batista, P, Gross, J, Pedrosa, A, Cournoyer, S, Leblanc, M, Chow, S, Karunakaran, S, Wong, G, Tobe, S, Desmeules, S, Zimmerman, D, Murphy, S, Montambault, P, Donnelly, S, Macrae, J, Culleton, B, Soroka, S, Rabbat, C, Jindal, K, Vasilevsky, M, Michaud, M, Wijeyesinghe, E, Zacharias, J, Lok, C, Muirhead, N, Verrelli, M, Da Roza, G, Sapir, D, Olgaard, K, Daugaard, H, Brandi, L, Jensen, P, Boulechfar, H, Ang, K, Simon, P, Rieu, P, Brunet, P, Touchard, G, Torres, P, Combe, C, Durrbach, A, Ortiz, J, Hannedouche, T, Vela, C, Lionet, A, Ryckelynck, P, Zaoui, P, Choukroun, G, Fessi, H, Lang, P, Stroumza, P, Joly, D, Mousson, C, Laville, M, Dellanna, F, Erley, C, Braun, J, Rambausek, M, Riegel, W, Klingberg, M, Schwertfeger, E, Wizemann, V, Eckardt, K, Reichel, H, Passauer, J, Hübel, E, Frischmuth, N, Liebl, R, Fiedler, R, Schwenger, V, Voßkühler, A, Kunzendorf, U, Renders, L, Rattensberger, D, Rump, L, Ketteler, M, Neumayer, H, Zantvoort, F, Stahl, R, Ladanyi, E, Braun, B, Kulcsar, I, Mezei, I, Csiky, B, Rikker, C, Arkossy, O, Berta, K, Szegedi, J, Major, L, Ferenczi, S, Fekete, A, Szabo, T, Zakar, G, Wagner, G, Erdelyine, S, Borbas, B, Eustace, J, Reddan, D, Capasso, G, Locatelli, F, Villa, G, Cozzolino, M, Brancaccio, D, Messa, P, Bolasco, P, Ricciardi, B, Malberti, F, Moriero, E, Cannella, G, Ortalda, V, Stefoni, S, Frascà, G, Cappelli, G, Albertazzi, A, Zoccali, C, Farina, M, Elli, A, Avella, F, Ondei, P, Mingardi, G, Errico, R, Losito, A, Di Giulio, S, Pertosa, G, Schena, F, Grandaliano, G, Gesualdo, L, Auricchio, M, Bochicchio-Ricardelli, T, Correa-Rotter, J, Verástegui, F, Peña, J, Wong, A, Cruz-Valdez, J, Zamora, M, Solis, M, Diaz, M, Flores, M, Sandoval, E, van den Dorpel, M, Brink, H, Van Kuijk, W, Vermeij, C, Gregoor, P, Hagen, E, van der Sande, F, Klinger, M, Nowicki, M, Muszytowski, M, Bidas, K, Bentkowski, W, Wiecek, A, Ksiazek, A, Marczewski, K, Ostrowski, M, Switalski, M, Sulowicz, W, Matuszkiewicz-Rowinska, J, Mysliwiec, M, Durlik, M, Rutkowski, B, Macario, F, Carvalho, B, Frazao, J, Machado, D, Weigert, A, Andrusev, A, Khrustalev, O, Zemtchenkov, A, Gurevich, K, Staroselsky, K, Khadikova, N, Rozhinskaya, L, Timokhovskaya, G, Strokov, A, Balkarova, O, Ermolenko, V, Kolmakova, E, Komandenko, M, Timofeev, M, Shilo, V, Shostka, G, Smirnov, A, Anashkin, V, Volgina, G, Domashenko, O, Gurevich, A, Perlin, D, García, J, Ribes, E, Piera, E, Lucas, M, Galicia, M, Prados, M, González, M, Romero, R, de Francisco, Ám, Montenegro, J, Santiago, C, García, F, de La Ossa, J, Arrieta, J, Pons, J, Martín-Malo, A, Amigó, J, Cases, A, Sterner, G, Jensen, G, Wikström, B, Jacobson, S, Lund, U, Weiss, L, Ståhl, A, von Albertini, B, Burnier, M, Meier, P, Martin, P, Uehlinger, D, Dickenmann, M, Yaqoob, M, Zehnder, D, Kalra, P, Padmanabhan, N, Roe, S, Eadington, D, Pritchard, N, Hutchison, A, Davies, S, Wilkie, M, Davies, M, Pai, P, Swift, P, Kwan, J, Goldsmith, D, Tomson, C, Stratton, J, Dasgupta, I, Sarkar, S, Moustafa, M, Gandhi, K, Jamal, A, Galindo-Ramos, E, Tuazon, J, Batlle, D, Tucker, K, Schiller-Moran, B, Assefi, A, Martinez, C, Samuels, L, Goldman, J, Cangiano-Rivera, J, Darwish, R, Lee, M, Topf, J, Kapatkin, K, Baer, H, Kopelman, R, Acharya, M, Tharpe, D, Bernardo, M, Nader, P, Guzman-Rivera, J, Pergola, P, Sekkarie, M, Alas, E, Zager, P, Liss, K, Navarro, J, Roppolo, M, Denu-Ciocca, C, Kshirsagar, A, El Khatib, M, Kant, K, Scott, D, Murthyr, B, Finkelstein, F, Keightley, G, Mccrary, R, Pitone, J, Cavalieri, T, Tsang, A, Pellegrino, B, Schmidt, R, Ahmad, S, Brown, C, Friedman, E, Mittman, N, Fadem, S, Shapiro, W, Reddy, M, Goldberger, S, Woredekal, Y, Agarwal, A, Anger, M, Haque, M, Chidester, P, Kohli, R, Rubinstein, S, Newman, G, Gladish, R, Ayodeji, O, Soman, S, Sprague, S, Hunt, N, Gehr, T, Rizk, D, Warnock, D, Polack, D, Pahl, M, Fischer, D, Dreyer, P, James, G, Husserl, F, Rogers, T, Raff, A, Sedor, J, Silver, M, Smith, M, Steinberg, S, Delgiorno, T, Jones, E, Cunha, P, Cheng, J, Pogue, V, Blumenthal, S, Brown, E, Charytan, C, Buerkert, J, Cook, M, Felsenfeld, A, Tareen, N, Gupta, A, Herman, T, Diamond, S, Hura, C, Laski, M, Maclaurin, J, Plumb, T, Brosnahan, G, Kumar, J, Henriquez, M, Poole, C, Osanloo, E, Matalon, A, Sholer, C, Arfeen, S, Azer, M, Belledonne, M, Gross, M, Dunnigan, E, Mcconnell, K, Becker, B, Rigolosi, R, Spiegel, D, Stegman, M, Patak, R, Streja, D, Ranjit, U, Youell, T, Wooldridge, T, Stafford, C, Cottiero, R, Weinberg, M, Schonefeld, M, Shahmir, E, Hazzan, A, Ashfaq, A, Bhandari, K, Cleveland, W, Culpepper, M, Golden, J, Lai, L, Lien, Y, Lorica, V, Robertson, J, Malireddi, K, Morse, S, Thakur, V, Israelit, A, Raguram, P, Alfred, H, Weise, W, Al-Saghir, F, El Shahawy, M, Rastogi, A, Nissenson, A, Kopyt, N, Lynn, R, Lea, J, Mcclellan, W, Teredesai, P, Ong, S, Tolkan, S, Sugihara, J, Minga, T, Mehrotra, R, Minasian, R, Bhatia, D, Specter, R, Capelli, J, Sidhu, P, Dalal, S, Dykes, P, Khan, M, Rahim, F, Saklayen, M, Thomas, A, Michael, B, Torres, M, Al-Bander, H, Murray, B, Abukurah, A, Gupta, B, Nosrati, S, Raja, R, Zeig, S, Braun, M, Amatya, A, Endsley, J, Sharon, Z, Dolson, G, Dumler, F, Ntoso, K, Rosansky, S, Kumar, N, Gura, V, Thompson, N, Goldfarb, D, Halligan, R, Middleton, J, Widerhorn, A, Arbeit, L, Arruda, J, Crouch, T, Friedman, L, Khokhar, S, Mittleman, J, Light, P, Taparia, B, West, C, Cotton, J, Dhingra, R, Kleinman, L, Arif, F, Lew, S, Nammour, T, Sterrett, J, Williams, M, Ramirez, J, Rubin, J, Mccarthy, J, Noble, S, Chaffin, M, and Rekhi, A.
- Subjects
Adult ,Male ,Dialysis ,Cinacalcet ,Cardiovascular Disease ,medicine.medical_specialty ,Calcimimetic ,medicine.medical_treatment ,Naphthalenes ,Coronary artery disease ,Renal Dialysis ,Internal medicine ,Odds Ratio ,medicine ,Humans ,Intensive care medicine ,Aged ,Etelcalcetide ,Hyperparathyroidism ,Hypocalcemia ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Intention to Treat Analysis ,Cardiovascular Diseases ,Parathyroid Hormone ,Cinacalcet Hydrochloride ,Kidney Failure, Chronic ,Female ,Hyperparathyroidism, Secondary ,Secondary hyperparathyroidism ,business ,medicine.drug - Abstract
Disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute to extraskeletal (including vascular) calcification among patients with chronic kidney disease. It has been hypothesized that treatment with the calcimimetic agent cinacalcet might reduce the risk of death or nonfatal cardiovascular events in such patients.In this clinical trial, we randomly assigned 3883 patients with moderate-to-severe secondary hyperparathyroidism (median level of intact parathyroid hormone, 693 pg per milliliter [10th to 90th percentile, 363 to 1694]) who were undergoing hemodialysis to receive either cinacalcet or placebo. All patients were eligible to receive conventional therapy, including phosphate binders, vitamin D sterols, or both. The patients were followed for up to 64 months. The primary composite end point was the time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event. The primary analysis was performed on the basis of the intention-to-treat principle.The median duration of study-drug exposure was 21.2 months in the cinacalcet group, versus 17.5 months in the placebo group. The primary composite end point was reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo group (relative hazard in the cinacalcet group vs. the placebo group, 0.93; 95% confidence interval, 0.85 to 1.02; P=0.11). Hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients receiving cinacalcet.In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).
- Published
- 2012
3. Cinacalcet, fibroblast growth factor-23, and cardiovascular disease in hemodialysis: The evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial
- Author
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Moe S. M., Chertow G. M., Parfrey P. S., Kubo Y., Block G. A., Correa-Rotter R., Drueke T. B., Herzog C. A., London G. M., Mahaffey K. W., Wheeler D. C., Stolina M., Dehmel B., Goodman W. G., Floege J., Santos J., Najun Zarazaga C., Marin I., Garrote N., Cusumano A., Penalba N., Del Valle E., Juncos L., Martinez Saye J., Lef L., Altobelli V., Petraglia G., Rosa Diez G., Douthat W., Lobo J., Gallart C., Lafalla A., Diez G., Linares B., Lopez N., Ramirez N., Gonzalez R., Valtuille R., Beresan H., Hermida O., Rudolf G., Marchetta N., Rano M., Ramirez M., Garcia N., Gillies A., Jones B., Pedagogos E., Walker R., Talaulikar G., Bannister K., Suranyi M., Kark A., Roger S., Kerr P., Disney A., Mount P., Fraenkel M., Mathew M., Fassett R., Jose M., Hawley C., Lonergan M., Mackie J., Ferrari P., Menahem S., Sabto J., Hutchison B., Langham R., Pollock C., Holzer H., Oberbauer R., Arias I., Graf H., Mayer G., Lhotta K., Neyer U., Klauser R., Hoerl W., Horn S., Kovarik J., Kramar R., Eigner M., Dhaene M., Billiouw J., De Meester J., Warling X., Cambier-Dwelschauwers P., Evenepoel P., Daelemans R., Dratwa M., Maes B., Stolear J., Dejagere T., Vanwalleghem J., Bouman K., Jadoul M., Peeters J., Vanholder R., Tielemans C., Donck J., Almeida F., Picollo De Oliveira J., Burdmann E., Garcia V., Saldanha Thome F., Deboni L., Bregman R., Lugon J., Araujo S., Ferreira Filho S., De Francesco Daher E., Sperto Baptista M., Carvalho A., D'Avila D., Moyses Neto M., Yu L., Bastos M., Sampaio Lacativa P., Jorgetti V., De Almeida Romao E., Cardeal Da Costa J., Pecoits Filho R., Gordan P., Salgado N., Teixeira Araujo M., Neiva Coelho S., Oliveira I., Moyses R., Vasconcellos L., Batista P., Luiz Gross J., Pedrosa A., Cournoyer S., LeBlanc M., Chow S., Karunakaran S., Wong G., Tobe S., Desmeules S., Zimmerman D., Murphy S., Montambault P., Donnelly S., MacRae J., Culleton B., Soroka S., Rabbat C., Jindal K., Vasilevsky M., Michaud M., Wijeyesinghe E., Zacharias J., Lok C., Muirhead N., Verrelli M., Da Roza G., Sapir D., Olgaard K., Daugaard H., Brandi L., Jensen P., Boulechfar H., Ang K., Simon P., Rieu P., Brunet P., Touchard G., Urena Torres P., Combe C., Durrbach A., Ortiz J., 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M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo De Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., De Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., De Almeida Romao, E., Cardeal Da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., Van Den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., Van Der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar De La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., Von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, 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D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., Rekhi, A., and Clinical sciences
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Adult ,Male ,Fibroblast growth factor 23 ,medicine.medical_specialty ,Cinacalcet ,Calcimimetic ,medicine.medical_treatment ,Naphthalenes ,Hyperthyroidism ,Gastroenterology ,ventricular remodeling ,Renal Dialysis ,Cinacalcet Hydrochloride ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,renal insufficiency, chronic ,Aged ,Etelcalcetide ,calcium ,business.industry ,Research Support, Non-U.S. Gov't ,death, sudden, cardiac ,Middle Aged ,arrhythmias, cardiac ,Cardiovascular Diseases ,Female ,Fibroblast Growth Factors ,Cardiology and Cardiovascular Medicine ,medicine.disease ,Fibroblast Growth Factor-23 ,Endocrinology ,Randomized Controlled Trial ,Secondary hyperparathyroidism ,Hemodialysis ,business ,medicine.drug ,Kidney disease - Abstract
Background— Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events. Methods and Results— This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy (phosphate binders/vitamin D) in patients receiving hemodialysis with secondary hyperparathyroidism (intact parathyroid hormone ≥300 pg/mL). The primary study end point was time to death or a first nonfatal cardiovascular event (myocardial infarction, hospitalization for angina, heart failure, or a peripheral vascular event). This analysis included 2985 patients (77% of randomized) with serum samples at baseline and 2602 patients (67%) with samples at both baseline and week 20. The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had ≥30% (68% versus 28%) reductions in FGF23. Among patients randomized to cinacalcet, a ≥30% reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point (relative hazard, 0.82; 95% confidence interval, 0.69–0.98), cardiovascular mortality (relative hazard, 0.66; 95% confidence interval, 0.50–0.87), sudden cardiac death (relative hazard, 0.57; 95% confidence interval, 0.37–0.86), and heart failure (relative hazard, 0.69; 95% confidence interval, 0.48–0.99). Conclusions— Treatment with cinacalcet significantly lowers serum FGF23. Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00345839.
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- 2015
4. Efficacy of low oral doses of iodized oil in the control of iodine deficiency in Zaire
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Tonglet, René, Bourdoux, Pierre, Minga, T, Ermans, André Marie, Tonglet, René, Bourdoux, Pierre, Minga, T, and Ermans, André Marie
- Abstract
About one billion people worldwide are at risk for iodine deficiency. Despite existing programs of prophylaxis, the prevention of iodine deficiency is still a challenge throughout the developing world. We studied the efficacy of low doses of iodized oil in an area of severe iodine deficiency in Zaire., Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, SCOPUS: cp.j, info:eu-repo/semantics/published
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- 1992
5. 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 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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 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(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. A., Hussein, Z., Fung, Y. K., Hassan, W. H. H. W., Wong, H. S., Goh, B. L., Ali, N. M., Merican, N. S. Y. A., Vaithilingam, I., Nik Ahmad, N. N. F., Adam, N., Sukor, N., Vengadasalam, V. P. P., Abdul Kadir, K., Mohamed, M., Renoirte Lopez, K., Leguizamo-Dimas, A., Chew Wong, A., Chevaile-Ramos, J., Gonzalez Gonzalez, J., Rico Hernandez, R., Nino-Cruz, J., Sauque Reyna, L., Gonzalez-Galvez, G., Madero Rovalo, M., Bochicchio-Ricardelli, T., Aldrete, J., Carranza-Madrigal, J., Vogt, L., Smak Gregoor, P., Barendregt, J. N. M., Luik, P., Gansevoort, R., Laverman, G., Pilmore, H., Lunt, H., Baker, J., Miller, S., Rabindranath, K., Zapata-Rincon, L., Vargas-Gonzales, R., Calderon Ticona, J., Dextre Espinoza, A., Burga Nunez, J., Zea-Nunez, C. 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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
6. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial
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P. Ryckelynck, Y. Woredekal, T. Gehr, Marian Klinger, J. Passauer, K. Liss, E. Del Valle, B. Linares, Ferdinando Avella, Stolear Jc, S. Tolkan, O. Hermida, V. Wizemann, Ricardo Correa-Rotter, J. Santos, Gert Mayer, Michael Anger, B. Pellegrino, B. Wikström, A. Ståhl, H. Al-Bander, Pedro Alejandro Gordan, Philip A. Kalra, E. Galindo-Ramos, Carmine Zoccali, G. Dolson, M. Eigner, Sanjay Dalal, G. Touchard, J Peeters, G. Da Roza, Shannon Murphy, R. Errico, M. Lonergan, A. Andrusev, H. Boulechfar, P. Zaoui, Michael Suranyi, de Francisco Martín de Francisco, S. Jacobson, B. Gupta, C. Stafford, J. Picollo de Oliveira, Ilka Regina Souza de Oliveira, F. Dumler, J. Martinez Saye, E. de Almeida Romão, Emmanuel A. Burdmann, C. Vermeij, N. Kumar, E. Shahmir, J. Stratton, R. Schmidt, Mario Cozzolino, Lars Christian Rump, Rainer Oberbauer, J. Kumar, M. Saklayen, Brian Hutchison, C. Denu-Ciocca, L. Weiss, E. Friedman, L. Renders, K. Gurevich, L. Brandi, W. Shapiro, Kym M. Bannister, K. 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Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo de Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., de Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., de Almeida Romao, E., Cardeal da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., London, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., van den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., van der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar de La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, B., Assefi, A., Martinez, C., Samuels, L., Goldman, J., Cangiano-Rivera, J., Darwish, R., Lee, M., Topf, J., Kapatkin, K., Baer, H., Kopelman, R., Acharya, M., Tharpe, D., Bernardo, M., Nader, P., Guzman-Rivera, J., Pergola, P., Sekkarie, M., Alas, E., Zager, P., Liss, K., Navarro, J., Roppolo, M., Denu-Ciocca, C., Kshirsagar, A., El Khatib, M., Kant, K., Scott, D., Murthyr, B., Finkelstein, F., Keightley, G., Mccrary, R., Pitone, J., Cavalieri, T., Tsang, A., Pellegrino, B., Schmidt, R., Ahmad, S., Brown, C., Friedman, E., Mittman, N., Fadem, S., Shapiro, W., Reddy, M., Goldberger, S., Woredekal, Y., Agarwal, A., Anger, M., Haque, M., Chidester, P., Kohli, R., Rubinstein, S., Newman, G., Gladish, R., Ayodeji, O., Soman, S., Sprague, S., Hunt, N., Gehr, T., Rizk, D., Warnock, D., Polack, D., Pahl, M., Fischer, D., Dreyer, P., James, G., Husserl, F., Rogers, T., Raff, A., Sedor, J., Silver, M., Smith, M., Steinberg, S., Delgiorno, T., Jones, E., Cunha, P. D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., and Rekhi, A.
- Subjects
Parathyroidectomy ,Adult ,Male ,medicine.medical_specialty ,Cinacalcet ,Epidemiology ,medicine.medical_treatment ,Calcimimetic Agents ,Critical Care and Intensive Care Medicine ,Lower risk ,Severity of Illness Index ,CKD ,cardiovascular disease ,hemodialysis ,hyperparathyroidism ,mineral metabolism ,Age Factors ,Aged ,Aged, 80 and over ,Cardiovascular Diseases ,Cinacalcet Hydrochloride ,Female ,Humans ,Hyperparathyroidism, Secondary ,Kidney Failure, Chronic ,Kidney Transplantation ,Middle Aged ,Renal Dialysis ,Nephrology ,Transplantation ,Internal medicine ,medicine ,Intensive care medicine ,Hyperparathyroidism ,business.industry ,Original Articles ,medicine.disease ,Secondary hyperparathyroidism ,Hemodialysis ,business ,medicine.drug - Abstract
Background andobjectivesThecalcimimeticcinacalcet reduced therisk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients. Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified. ResultsOlderpatients hadhigher baselineprevalenceof diabetesmellitusandCV comorbidity. Annualizedrates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. Conclusions In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone. Clin J Am Soc Nephrol 10: ccc–ccc, 2015. doi: 10.2215/CJN.07730814
- Published
- 2015
7. First-in-Human Evaluation of Safety, Pharmacokinetics and Muscle Glycogen Lowering of a Novel Glycogen Synthase 1 Inhibitor for the Treatment of Pompe Disease.
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Ullman JC, Dick RA, Linzner D, Minga T, Tep S, Satterfield TF, Xi Y, Beattie DT, Marmon T, Neutel JM, Chung B, Leeds JM, Noonberg SB, Green EM, and Bernstein HS
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- Humans, Male, Adult, Female, Middle Aged, Young Adult, Enzyme Inhibitors pharmacokinetics, Enzyme Inhibitors administration & dosage, Enzyme Inhibitors adverse effects, Enzyme Inhibitors therapeutic use, Enzyme Inhibitors pharmacology, Administration, Oral, Dose-Response Relationship, Drug, Enzyme Replacement Therapy methods, Double-Blind Method, Half-Life, Glycogen Storage Disease Type II drug therapy, Glycogen metabolism, Glycogen Synthase metabolism, Muscle, Skeletal drug effects, Muscle, Skeletal metabolism
- Abstract
Pompe disease is a rare glycogen storage disease caused by mutations in the enzyme acid α-glucosidase (GAA) resulting in pathological accumulation of glycogen in muscle tissues leading to progressive weakness and respiratory dysfunction. Enzyme replacement therapy (ERT) with GAA is currently the sole treatment option for patients with Pompe disease. ERT burdens patients with frequent intravenous infusions while insufficiently halting disease progression due to incomplete ERT skeletal muscle distribution. Glycogen synthase 1 (GYS1) has been proposed as a substrate reduction therapy (SRT) target for Pompe disease. Here, we report results from the first-in-human study of the orally available GYS1 inhibitor MZE001 in healthy subjects. In 88 participants, MZE001 was well-tolerated up to a single dose of 480 mg BID and multiple doses of 720 mg BID for 10 days. Noncompartmental analysis determined that the half-life and C
trough concentrations of MZE001 could provide efficacious exposures with once or twice daily oral dosing. Change from baseline of peripheral blood mononuclear cell (PBMC) glycogen, which correlated with muscle glycogen levels in preclinical models, was significantly reduced dose-dependently following 10 days of MZE001 treatment in healthy subjects. A muscle biopsy sub-study demonstrated that 10 days of MZE001 (480 mg BID) dosing safely and substantially lowered muscle glycogen stores in healthy adults. This correlated with the PBMC exposure response and supports the use of PBMC glycogen reduction as a surrogate for muscle response, and MZE001 potential for development as the first oral substrate reduction therapy for patients with Pompe disease., (© 2024 Maze Therapeutics. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)- Published
- 2024
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8. Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non - Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO 2 TECT Randomized Clinical Trial of ESA-Treated Patients.
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Parfrey PS, Burke SK, Chertow GM, Eckardt KU, Jardine AG, Lewis EF, Luo W, Matsushita K, McCullough PA, Minga T, and Winkelmayer WC
- Abstract
Rationale & Objective: In the PRO
2 TECT trials, vadadustat was found to be noninferior to darbepoetin alfa in hematologic efficacy but not for major adverse cardiovascular events (MACE; all-cause death or nonfatal myocardial infarction or stroke) in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). We investigated the regional differences in MACE in the PRO2 TECT trials., Study Design: Phase 3, global, open-label, randomized, active-controlled clinical trial., Setting & Participants: A total of 1,725 erythropoiesis-stimulating agent (ESA)-treated patients with anemia and NDD-CKD., Intervention: 1:1 randomization to receive vadadustat or darbepoetin alfa., Outcomes: The primary safety end point was the time to first MACE., Results: At baseline, patients in Europe (n=444) were primarily treated with darbepoetin alfa, showed higher proportions on low ESA doses (<90 U/kg/wk epoetin alfa equivalents) with a hemoglobin concentration of ≥10 g/dL compared with patients in the US (n=665) and non-US/non-Europe (n=614) regions. The MACE rates per 100 person-years in the 3 vadadustat groups across regions were 14.5 in the US, 11.6 in Europe, and 10.0 in the non-US/non-Europe groups, whereas event rates in the darbepoetin alfa group were considerably lower in Europe than in the US and non-US/non-Europe groups (6.7 vs 13.3 and 10.5, respectively). The overall hazard ratio for MACE for vadadustat vs darbepoetin alpha was 1.16; 95% CI, 0.93-1.45, but varied by geographical region, with a greater hazard ratio seen in Europe (US, 1.07; 95% CI, 0.78-1.46; Europe, 2.05; 95% CI, 1.24-3.39; non-US/non-Europe, 0.91; 95% CI, 0.60-1.37); interaction between study treatment and geographical region, P = 0.07). In Europe, ESA rescue was associated with a higher risk of MACE in both groups., Limitations: Several analyses are exploratory., Conclusions: In this trial, there was a low risk of MACE in the darbepoetin alfa group in Europe. Patients in Europe were generally on low doses of ESA, with hemoglobin already within target range. The low risk of MACE may have been related to a limited need to switch and titrate darbepoetin alfa compared with the non-US/non-Europe group., Funding: Akebia Therapeutics, Inc., Trial Registration: ClinicalTrials.gov identifier: NCT02680574., (© 2023 The Authors.)- Published
- 2023
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9. Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non-Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO 2 TECT Randomized Clinical Trial of ESA-Naïve Patients.
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Winkelmayer WC, Arnold S, Burke SK, Chertow GM, Eckardt KU, Jardine AG, Lewis EF, Luo W, Matsushita K, McCullough PA, Minga T, and Parfrey PS
- Abstract
Rationale & Objective: Prespecified analyses of the PRO
2 TECT trials comparing the safety of the oral hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat with darbepoetin alfa in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) found no difference in major adverse cardiovascular events (MACE; death from any cause or nonfatal myocardial infarction or stroke) among US patients and a higher risk among patients treated with vadadustat outside the United States. We investigated regional differences in MACE in the PRO2 TECT trial that enrolled 1,751 patients previously untreated with erythropoiesis-stimulating agents., Study Design: Phase 3, global, open-label, randomized, active-controlled clinical trial., Setting and Participants: Erythropoiesis-stimulating agent-untreated patients with anemia and NDD-CKD., Intervention: Eligible patients were randomized 1:1 to receive vadadustat or darbepoetin alfa., Outcomes: The primary safety end point was time to first MACE. Secondary safety end points included time to first expanded MACE (MACE plus hospitalization for heart failure or thromboembolic event, excluding vascular access thrombosis)., Results: In the non-US/non-Europe region, there was a higher proportion of patients with baseline estimated glomerular filtration rate (eGFR) level of ≤10 mL/min/1.73 m2 in the vadadustat group [96 (34.7%)] than in the darbepoetin alfa group [66 (24.0%)]. In this region, there were 21 excess MACEs reported in the vadadustat group [78 events (n=276)] versus the darbepoetin alfa [57 events (n=275)], including 13 excess noncardiovascular deaths, largely from kidney failure. Noncardiovascular deaths were concentrated in Brazil and South Africa, which enrolled higher proportions of patients with an eGFR of ≤10 mL/min/1.73 m2 and who may not have had access to dialysis., Limitations: Different regional treatment patterns of patients with NDD-CKD., Conclusions: The higher MACE rate in the non-US/non-Europe vadadustat group may have been partly because of imbalances in the baseline eGFR level in countries where dialysis was not uniformly available resulting in many kidney-related deaths., (© 2023 The Authors.)- Published
- 2023
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10. Erythropoietic effects of vadadustat in patients with anemia associated with chronic kidney disease.
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Koury MJ, Agarwal R, Chertow GM, Eckardt KU, Fishbane S, Ganz T, Haase VH, Hanudel MR, Parfrey PS, Pergola PE, Roy-Chaudhury P, Tumlin JA, Anders R, Farag YMK, Luo W, Minga T, Solinsky C, Vargo DL, and Winkelmayer WC
- Subjects
- Clinical Trials, Phase III as Topic, Darbepoetin alfa therapeutic use, Erythropoiesis, Ferritins, Glycine analogs & derivatives, Hemoglobins metabolism, Hepcidins, Humans, Iron therapeutic use, Picolinic Acids, Randomized Controlled Trials as Topic, Transferrins therapeutic use, Anemia drug therapy, Anemia etiology, Erythropoietin therapeutic use, Hematinics therapeutic use, Renal Insufficiency, Chronic complications, Renal Insufficiency, Chronic drug therapy
- Abstract
Patients with chronic kidney disease (CKD) develop anemia largely because of inappropriately low erythropoietin (EPO) production and insufficient iron available to erythroid precursors. In four phase 3, randomized, open-label, clinical trials in dialysis-dependent and non-dialysis-dependent patients with CKD and anemia, the hypoxia-inducible factor prolyl hydroxylase inhibitor, vadadustat, was noninferior to the erythropoiesis-stimulating agent, darbepoetin alfa, in increasing and maintaining target hemoglobin concentrations. In these trials, vadadustat increased the concentrations of serum EPO, the numbers of circulating erythrocytes, and the numbers of circulating reticulocytes. Achieved hemoglobin concentrations were similar in patients treated with either vadadustat or darbepoetin alfa, but compared with patients receiving darbepoetin alfa, those receiving vadadustat had erythrocytes with increased mean corpuscular volume and mean corpuscular hemoglobin, while the red cell distribution width was decreased. Increased serum transferrin concentrations, as measured by total iron-binding capacity, combined with stable serum iron concentrations, resulted in decreased transferrin saturation in patients randomized to vadadustat compared with patients randomized to darbepoetin alfa. The decreases in transferrin saturation were associated with relatively greater declines in serum hepcidin and ferritin in patients receiving vadadustat compared with those receiving darbepoetin alfa. These results for serum transferrin saturation, hepcidin, ferritin, and erythrocyte indices were consistent with improved iron availability in the patients receiving vadadustat. Thus, overall, vadadustat had beneficial effects on three aspects of erythropoiesis in patients with anemia associated with CKD: increased endogenous EPO production, improved iron availability to erythroid cells, and increased reticulocytes in the circulation., (© 2022 Akebia Therapeutics Inc and The Authors. American Journal of Hematology published by Wiley Periodicals LLC.)
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- 2022
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11. Clinical consequences of infected arteriovenous grafts in hemodialysis patients.
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Minga TE, Flanagan KH, and Allon M
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- Anti-Bacterial Agents therapeutic use, Catheters, Indwelling, Female, Hospitalization statistics & numerical data, Humans, Male, Prosthesis-Related Infections drug therapy, Prosthesis-Related Infections microbiology, Serum Albumin metabolism, Staphylococcal Infections drug therapy, Staphylococcal Infections microbiology, Staphylococcus aureus drug effects, Staphylococcus epidermidis drug effects, Time Factors, Arteriovenous Shunt, Surgical adverse effects, Blood Vessel Prosthesis adverse effects, Prosthesis-Related Infections etiology, Renal Dialysis, Staphylococcal Infections etiology
- Abstract
Arteriovenous (AV) graft infection is a serious adverse event in hemodialysis patients; however, there is little published literature describing its consequences. We identified prospectively all AV graft infections occurring at our institution during a 4.5-year period. We analyzed immediate complications, as well as long-term consequences, including the need for subsequent vascular-access procedures and duration of catheter-dependent dialysis therapy. Ninety graft infections were identified in 78 patients, yielding a rate of 8.2 infections/100 graft-years. Patients with graft infection were much more likely to have a low serum albumin level (<3.5 g/dL) in the month preceding the infection compared with noninfected controls (73% versus 18%; P < 0.001). Infections occurred within 1 month of graft placement in 15%, at 1 to 12 months in 44%, and longer than 1 year from surgery in 41%. The pathogen was a gram-positive coccus in 97% of cases, particularly Staphylococcus aureus (60%) and Staphylococcus epidermidis (22%). The initial graft infection entailed hospitalization for a mean of 7.5 days. Eleven patients (12%) developed a total of 17 major complications, including death (5 patients), clinical sepsis requiring vasopressors (4 patients), septic arthritis (3 patients), epidural abscess (1 patient), endocarditis (1 patient), osteomyelitis (1 patient), myocardial infarction (1 patient), and cerebrovascular accident (1 patient). After removal of an infected graft, patients were catheter dependent for a median of 3.8 months. The duration of catheter dependence was less than 3 months in 36%, 3 to 6 months in 38%, 6 to 12 months in 14%, and greater than 1 year in 12%. During the period of catheter dependence, patients required a mean of 9.7 access procedures, including graft removal (1.0 procedure), nontunneled dialysis catheters (4.4 procedures), tunneled dialysis catheters (3.0 procedures), and new permanent accesses (1.4 procedures). In addition, patients averaged 0.85 episodes of bacteremia while they were catheter dependent. In conclusion, graft infection results in substantial morbidity, prolonged dependence on dialysis catheters, and multiple vascular-access procedures.
- Published
- 2001
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12. Efficacy of low oral doses of iodized oil in the control of iodine deficiency in Zaire.
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Tonglet R, Bourdoux P, Minga T, and Ermans AM
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- Administration, Oral, Adolescent, Adult, Child, Child, Preschool, Democratic Republic of the Congo, Female, Humans, Infant, Infant, Newborn, Iodine urine, Male, Thyrotropin blood, Thyroxine blood, Goiter, Endemic drug therapy, Iodine deficiency, Iodized Oil administration & dosage
- Abstract
Background: About one billion people worldwide are at risk for iodine deficiency. Despite existing programs of prophylaxis, the prevention of iodine deficiency is still a challenge throughout the developing world. We studied the efficacy of low doses of iodized oil in an area of severe iodine deficiency in Zaire., Methods: Seventy-five subjects with visible goiter were randomly assigned to receive a single oral dose of placebo or either 0.1 or 0.25 ml of iodized oil, corresponding to 0, 47, and 118 mg of iodine, respectively. The mean ages of the subjects in the three groups were 23, 22, and 22 years, respectively, and the ratios of males to females were 0.25, 0.32, and 0.19. Efficacy was assessed by evaluating goiter size and measuring urinary iodine and serum thyroid hormone concentrations for 12 months., Results: Goiter size decreased in most of the subjects who received either dose of iodized oil. Their urinary iodine concentrations were normal for six to nine months and their serum thyroxine and thyrotropin concentrations were nearly all normal throughout the study period. There were no side effects, even in subjects whose serum thyroxine concentrations had initially been low. In the placebo group, neither goiter size nor any of the biochemical values changed., Conclusions: The oral administration of a single small dose of iodized oil is capable of correcting iodine deficiency for about a year. This method of supplementation is likely to be more effective, efficient, and acceptable than the administration of either intramuscular or large oral doses of iodized oil.
- Published
- 1992
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