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1. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial

Author

Packer, M, Anker, S, Butler, J, Filippatos, G, Pocock, S, Zannad, F, Ferreira, JP, Brueckmann, M, George, J, Jamal, W, Welty, FK, Palmer, M, Clayton, T, Parhofer, KG, Pedersen, TR, Greenberg, B, Konstam, MA, Lees, KR, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, J, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Verma, S, Zhang, J, Spinar, J, Seronde, M-F, Boehm, M, Merkely, B, Chopra, V, Senni, M, Taddi, S, Tsutsui, H, Choi, D-J, Chuquiure, E, La Rocca, HPB, Ponikowski, P, Juanatey, JRG, Squire, I, Januzzi, J, Pina, I, Bernstein, R, Cheung, A, Green, J, Kaul, S, Lam, C, Lip, G, Marx, N, McCullough, P, Mehta, C, Rosenstock, J, Sattar, N, Scirica, B, Shah, S, Wanner, C, Aizenberg, D, Cartasegna, L, Colombo Berra, F, Colombo, H, Fernandez Moutin, M, Glenny, J, Alvarez Lorio, C, Anauch, D, Campos, R, Facta, A, Fernandez, A, Ahuad Guerrero, R, Lobo Márquez, L, Leon de la Fuente, RA, Mansilla, M, Hominal, M, Hasbani, E, Najenson, M, Moises Azize, G, Luquez, H, Guzman, L, Sessa, H, Amuchástegui, M, Salomone, O, Perna, E, Piskorz, D, Sicer, M, Perez de Arenaza, D, Zaidman, C, Nani, S, Poy, C, Resk, J, Villarreal, R, Majul, C, Smith Casabella, T, Sassone, S, Liberman, A, Carnero, G, Caccavo, A, Berli, M, Budassi, N, Bono, J, Alvarisqueta, A, Amerena, J, Kostner, K, Hamilton, A, Begg, A, Beltrame, J, Colquhoun, D, Gordon, G, Sverdlov, A, Vaddadi, G, Wong, J, Coller, J, Prior, D, Friart, A, Leone, A, Vervoort, G, Timmermans, P, Troisfontaines, P, Franssen, C, Sarens, T, Vandekerckhove, H, Van De Borne, P, Chenot, F, De Sutter, J, De Vuyst, E, Debonnaire, P, Dupont, M, Pereira Dutra, O, Canani, LH, Vieira Moreira, MdC, de Souza, W, Backes, LM, Maia, L, De Souza Paolino, B, Manenti, ER, Saporito, W, Villaça Guimarães Filho, F, Franco Hirakawa, T, Saliba, LA, Neuenschwander, FC, de Freitas Zerbini, CA, Gonçalves, G, Gonçalves Mello, Y, Ascenção de Souza, J, Beck da Silva Neto, L, Bocchi, EA, Da Silveira, J, de Moura Xavier Moraes Junior, JB, de Souza Neto, JD, Hernandes, M, Finimundi, HC, Sampaio, CR, Vasconcellos, E, Neves Mancuso, FJ, Noya Rabelo, MM, Rodrigues Bacci, M, Santos, F, Vidotti, M, Simões, MV, Gomes, FL, Vieira Nascimento, C, Precoma, D, Helfenstein Fonseca, FA, Ribas Fortes, JA, Leães, PE, Campos de Albuquerque, D, Kerr Saraiva, JF, Rassi, S, Alves da Costa, FA, Reis, G, Zieroth, S, Dion, D, Savard, D, Bourgeois, R, Constance, C, Anderson, K, Leblanc, M-H, Yung, D, Swiggum, E, Pliamm, L, Pesant, Y, Tyrrell, B, Huynh, T, Spiegelman, J, Lavoie, J-P, Hartleib, M, Bhargava, R, Straatman, L, Virani, S, Costa-Vitali, A, Hill, L, Heffernan, M, Khaykin, Y, Ricci, J, Senaratne, M, Zhai, A, Lubelsky, B, Toma, M, Yao, L, McKelvie, R, Noronha, L, Babapulle, M, Pandey, A, Curnew, G, Lavoie, A, Berlingieri, J, Kouz, S, Lonn, E, Chehayeb, R, Zheng, Y, Sun, Y, Cui, H, Fan, Z, Han, X, Jiang, X, Tang, Q, Zhou, J, Zheng, Z, Zhang, X, Zhang, N, Zhang, Y, Shen, A, Yu, J, Ye, J, Yao, Y, Yan, J, Xu, X, Wang, Z, Ma, J, Li, Y, Li, S, Lu, S, Kong, X, Song, Y, Yang, G, Yao, Z, Pan, Y, Guo, X, Sun, Z, Dong, Y, Zhu, J, Peng, D, Yuan, Z, Lin, J, Yin, Y, Jerabek, O, Burianova, H, Fiala, T, Hubac, J, Ludka, O, Monhart, Z, Vodnansky, P, Zeman, K, Foldyna, D, Krupicka, J, Podpera, I, Busak, L, Radvan, M, Vomacka, Z, Prosecky, R, Cifkova, R, Durdil, V, Vesely, J, Vaclavik, J, Cervinka, P, Linhart, A, Brabec, T, Miklik, R, Bourhaial, H, Olbrich, H-G, Genth-Zotz, S, Kemala, E, Lemke, B, Böhm, M, Schellong, S, Rieker, W, Heitzer, T, Ince, H, Faghih, M, Birkenfeld, A, Begemann, A, Ghanem, A, Ujeyl, A, von Haehling, S, Dorsel, T, Bauersachs, J, Prull, M, Weidemann, F, Darius, H, Nickenig, G, Wilke, A, Sauter, J, Rauch-Kroehnert, U, Frey, N, Schulze, CP, König, W, Maier, L, Menzel, F, Proskynitopoulos, N, Ebert, H-H, Sarnighausen, H-E, Düngen, H-D, Licka, M, Stellbrink, C, Winkelmann, B, Menck, N, López-Sendón, JL, de la Fuente Galán, L, Delgado Jiménez, JF, Manito Lorite, N, Pérez de Juan Romero, M, Galve Basilio, E, Cereto Castro, F, González Juanatey, JR, Gómez, JJ, Sanmartín Fernández, M, Garcia-Moll Marimon, X, Pascual Figal, D, Bover Freire, R, Bonnefoy Cudraz, E, Jobbe Duval, A, Tomasevic, D, Habib, G, Isnard, R, Picard, F, Khanoyan, P, Dubois-Rande, J-L, Galinier, M, Roubille, F, Alexandre, J, Babuty, D, Delarche, N, Berneau, J-B, Girerd, N, Saxena, M, Rosano, G, Yousef, Z, Clifford, C, Arden, C, Bakhai, A, Boos, C, Jenkins, G, Travill, C, Price, D, Koenyves, L, Lakatos, F, Matoltsy, A, Noori, E, Zilahi, Z, Andrassy, P, Kancz, S, Simon, G, Sydo, T, Vorobcsuk, A, Kiss, RG, Toth, K, Szakal, I, Nagy, L, Barany, T, Nagy, A, Szolnoki, E, Chopra, VK, Mandal, S, Rastogi, V, Shah, B, Mullasari, A, Shankar, J, Mehta, V, Oomman, A, Kaul, U, Komarlu, S, Kahali, D, Bhagwat, A, Vijan, V, Ghaisas, NK, Mehta, A, Kashyap, J, Kothari, Y, TaddeI, S, Scherillo, M, Zacà, V, Genovese, S, Salvioni, A, Fucili, A, Fedele, F, Cosmi, F, Volpe, M, Mazzone, C, Esposito, G, Doi, M, Yamamoto, H, Sakagami, S, Oishi, S, Yasaka, Y, Tsuboi, H, Fujino, Y, Matsuoka, S, Watanabe, Y, Himi, T, Ide, T, Ichikawa, M, Kijima, Y, Koga, T, Yuda, S, Fukui, K, Kubota, T, Manita, M, Fujinaga, H, Matsumura, T, Fukumoto, Y, Kato, R, Kawai, Y, Hiasa, G, Kazatani, Y, Mori, M, Ogimoto, A, Inoko, M, Oguri, M, Kinoshita, M, Okuhara, K, Watanabe, N, Ono, Y, Otomo, K, Sato, Y, Matsunaga, T, Takaishi, A, Miyagi, N, Uehara, H, Takaishi, H, Urata, H, Kataoka, T, Matsubara, H, Matsumoto, T, Suzuki, T, Takahashi, N, Imamaki, M, Yoshitama, T, Saito, T, Sekino, H, Furutani, Y, Koda, M, Shinozaki, T, Hirabayashi, K, Tsunoda, R, Yonezawa, K, Hori, H, Yagi, M, Arikawa, M, Hashizume, T, Ishiki, R, Koizumi, T, Nakayama, K, Taguchi, S, Nanasato, M, Yoshida, Y, Tsujiyama, S, Nakamura, T, Oku, K, Shimizu, M, Suwa, M, Momiyama, Y, Sugiyama, H, Kobayashi, K, Inoue, S, Kadokami, T, Maeno, K, Kawamitsu, K, Maruyama, Y, Nakata, A, Shibata, T, Wada, A, Cho, H-J, Na, JO, Yoo, B-S, Choi, J-O, Hong, SK, Shin, J-H, Cho, M-C, Han, SH, Jeong, J-O, Kim, J-J, Kang, SM, Kim, D-S, Kim, MH, Llamas Esperon, G, Illescas Díaz, J, Fajardo Campos, P, Almeida Alvarado, J, Bazzoni Ruiz, A, Echeverri Rico, J, Lopez Alcocer, I, Valle Molina, L, Hernandez Herrera, C, Calvo Vargas, C, Padilla Padilla, FG, Rodriguez Briones, I, Chuquiure Valenzuela, EJJR, Aguilera Real, ME, Carrillo Calvillo, J, Alpizar Salazar, M, Cervantes Escárcega, JL, Velasco Sanchez, R, Al - Windy, N, van Heerebeek, L, Bellersen, L, Brunner-La Rocca, H-P, Post, J, Linssen, GCM, van de Wetering, M, Peters, R, van Stralen, R, Groutars, R, Smits, P, Yilmaz, A, Kok, WEM, Van der Meer, P, Dijkmans, P, Troquay, R, van Alem, AP, Van de Wal, R, Handoko, L, Westendorp, ICD, van Bergen, PFMM, Rensing, BJWM, Hoogslag, P, Kietselaer, B, Kragten, JA, den Hartog, FR, Alings, A, Danilowicz-Szymanowicz, L, Raczak, G, Piesiewicz, W, Zmuda, W, Kus, W, Podolec, P, Musial, W, Drelich, G, Kania, G, Miekus, P, Mazur, S, Janik, A, Spyra, J, Peruga, J, Balsam, P, Krakowiak, B, Szachniewicz, J, Ginel, M, Grzybowski, J, Chrustowski, W, Wojewoda, P, Kalinka, A, Zurakowski, A, Koc, R, Debinski, M, Fil, W, Kujawiak, M, Forys, J, Kasprzak, M, Krol, M, Michalski, P, Mirek-Bryniarska, E, Radwan, K, Skonieczny, G, Stania, K, Skoczylas, G, Madej, A, Jurowiecki, J, Firek, B, Wozakowska-Kaplon, B, Cymerman, K, Neutel, J, Adams, K, Balfour, P, Deswal, A, Djamson, A, Duncan, P, Hong, M, Murray, C, Rinde-Hoffman, D, Woodhouse, S, MacNevin, R, Rama, B, Broome-Webster, C, Kindsvater, S, Abramov, D, Barettella, M, Pinney, S, Herre, J, Cohen, A, Vora, K, Challappa, K, West, S, Baum, S, Cox, J, Jani, S, Karim, A, Akhtar, A, Quintana, O, Paukman, L, Goldberg, R, Bhatti, Z, Budoff, M, Bush, E, Potler, A, Delgado, R, Ellis, B, Dy, J, Fialkow, J, Sangrigoli, R, Ferdinand, K, East, C, Falkowski, S, Donahoe, S, Ebrahimi, R, Kline, G, Harris, B, Khouzam, R, Jaffrani, N, Jarmukli, N, Kazemi, N, Koren, M, Friedman, K, Herzog, W, Silva Enciso, J, Cheung, D, Grover-McKay, M, Hauptman, P, Mikhalkova, D, Hegde, V, Hodsden, J, Khouri, S, McGrew, F, Littlefield, R, Bradley, P, McLaurin, B, Lupovitch, S, Labin, I, Rao, V, Leithe, M, Lesko, M, Lewis, N, Lombardo, D, Mahal, S, Malhotra, V, Dauber, I, Banerjee, A, Needell, J, Miller, G, Paladino, L, Munuswamy, K, Nanna, M, McMillan, E, Mumma, M, Napoli, M, Nelson, W, O'Brien, T, Adlakha, A, Onwuanyi, A, Serota, H, Schmedtje, J, Paraschos, A, Potu, R, Sai-Sudhakar, C, Saltzberg, M, Sauer, A, Shah, P, Skopicki, H, Bui, H, Carr, K, Stevens, G, Tahirkheli, N, Tallaj, J, Yousuf, K, Trichon, B, Welker, J, Tolerico, P, Vest, A, Vivo, R, Wang, X, Abadier, R, Dunlap, S, Weintraub, N, Malik, A, Kotha, P, Zaha, V, Kim, G, Uriel, N, Greene, T, Salacata, A, Arora, R, Gazmuri, R, Kobayashi, J, Iteld, B, Vijayakrishnan, R, Dab, R, Mirza, Z, Marques, V, Nallasivan, M, Bensimhon, D, Peart, B, Saint-Jacques, H, Barringhaus, K, Contreras, J, Gupta, A, Koneru, S, Nguyen, V, Verma, Subodh, Dhingra, Nitish K, Butler, Javed, Anker, Stefan D, Ferreira, Joao Pedro, Filippatos, Gerasimos, Januzzi, James L, Lam, Carolyn S P, Sattar, Naveed, Peil, Barbara, Nordaby, Matias, Brueckmann, Martina, Pocock, Stuart J, Zannad, Faiez, and Packer, Milton

Published
2022
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4. Evaluation of the effect of sodium–glucose co‐transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR‐Reduced trial

Author

Packer M., Butler J., Filippatos G. S., Jamal W., Salsali A., Schnee J., Kimura K., Zeller C., George J., Brueckmann M., Anker S. D., Zannad F., Perrone S., Nicholls S., Janssens S., Bocchi E., Giannetti N., Verma S., Jian Z., Spinar J., Seronde M. -F., Bohm M., Merkely B., Chopra V., Senni M., Taddei S., Tsutsui H., Choi D. -J., Chuquiure E., La Rocca H. P. B., Ponikowski P., Juanatey J. R. G., Squire I., Januzzi J., Pina I., Pocock S. J., Carson P., Doehner W., Miller A., Haas M., Pehrson S., Komajda M., Anand I., Teerlink J., Rabinstein A., Steiner T., Kamel H., Tsivgoulis G., Lewis J., Freston J., Kaplowitz N., Mann J., Petrie M., Bernstein R., Cheung A., Green J., Kaul S., Ping C. L. S., Lip G., Marx N., McCullough P., Mehta C., Rosenstock J., Sattar N., Scirica B., Wanner C., Welty F. K., Parhofer K. G., Clayton T., Pedersen T. R., Lees K. R., Konstam M. A., Greenberg B., Palmer M., Packer, M, Butler, J, Filippatos, G, Jamal, W, Salsali, A, Schnee, J, Kimura, K, Zeller, C, George, J, Brueckmann, M, Anker, S, Zannad, F, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Verma, S, Jian, Z, Spinar, J, Seronde, M, Bohm, M, Merkely, B, Chopra, V, Senni, M, Taddei, S, Tsutsui, H, Choi, D, Chuquiure, E, La Rocca, H, Ponikowski, P, Juanatey, J, Squire, I, Januzzi, J, Pina, I, Pocock, S, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, M, Bernstein, R, Cheung, A, Green, J, Kaul, S, Ping, C, Lip, G, Marx, N, Mccullough, P, Mehta, C, Rosenstock, J, Sattar, N, Scirica, B, Wanner, C, Welty, F, Parhofer, K, Clayton, T, Pedersen, T, Lees, K, Konstam, M, Greenberg, B, Palmer, M, RS: Carim - H02 Cardiomyopathy, MUMC+: MA Med Staf Spec Cardiologie (9), Cardiologie, and RS: CARIM - R2.02 - Cardiomyopathy

Subjects
MECHANISM, Trial design, medicine.medical_specialty, Cardiac & Cardiovascular Systems, NA+/H+-EXCHANGER, Heart failure, Type 2 diabetes, 030204 cardiovascular system & hematology, Diabete, SGLT2 INHIBITORS, Reduced ejection fraction, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Glucosides, Internal medicine, Diabetes mellitus, Clinical endpoint, Empagliflozin, Humans, Medicine, Benzhydryl Compounds, Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Randomized Controlled Trials as Topic, RISK, Canagliflozin, OUTCOMES, Science & Technology, Ejection fraction, diabetes, business.industry, Diabetes, Stroke Volume, SGLT2 inhibitor, medicine.disease, chemistry, HOSPITALIZATION, Chronic Disease, Cardiovascular System & Cardiology, Cardiology, Cardiology and Cardiovascular Medicine, business, Life Sciences & Biomedicine, medicine.drug
Abstract

Drugs that inhibit the sodium-glucose co-transporter 2 (SGLT2) have been shown to reduce the risk of hospitalizations for heart failure in patients with type 2 diabetes. In populations that largely did not have heart failure at the time of enrolment, empagliflozin, canagliflozin and dapagliflozin decreased the risk of serious new-onset heart failure events by ≈30%. In addition, in the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of both pump failure and sudden deaths, the two most common modes of death among patients with heart failure. In none of the three trials could the benefits of SGLT2 inhibitors on heart failure be explained by the actions of these drugs as diuretics or anti-hyperglycaemic agents. These observations raise the possibility that SGLT2 inhibitors could reduce morbidity and mortality in patients with established heart failure, including those without diabetes. The EMPEROR-Reduced trial is enrolling ≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤ 40%), half of whom are expected not to have diabetes. Patients are being randomized to placebo or empagliflozin 10 mg daily, which is added to all appropriate treatment with inhibitors of the renin-angiotensin system and neprilysin, beta-blockers and mineralocorticoid receptor antagonists. The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events. By adjusting eligibility based on natriuretic peptide levels to the baseline ejection fraction, the trial will preferentially enrol high-risk patients. A large proportion of the participants is expected to have an ejection fraction

Published
2019
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7. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial

Author

Verma, Subodh, primary, Dhingra, Nitish K, additional, Butler, Javed, additional, Anker, Stefan D, additional, Ferreira, Joao Pedro, additional, Filippatos, Gerasimos, additional, Januzzi, James L, additional, Lam, Carolyn S P, additional, Sattar, Naveed, additional, Peil, Barbara, additional, Nordaby, Matias, additional, Brueckmann, Martina, additional, Pocock, Stuart J, additional, Zannad, Faiez, additional, Packer, Milton, additional, Packer, M, additional, Anker, S, additional, Butler, J, additional, Filippatos, G, additional, Pocock, S, additional, Zannad, F, additional, Ferreira, JP, additional, Brueckmann, M, additional, George, J, additional, Jamal, W, additional, Welty, FK, additional, Palmer, M, additional, Clayton, T, additional, Parhofer, KG, additional, Pedersen, TR, additional, Greenberg, B, additional, Konstam, MA, additional, Lees, KR, additional, Carson, P, additional, Doehner, W, additional, Miller, A, additional, Haas, M, additional, Pehrson, S, additional, Komajda, M, additional, Anand, I, additional, Teerlink, J, additional, Rabinstein, A, additional, Steiner, T, additional, Kamel, H, additional, Tsivgoulis, G, additional, Lewis, J, additional, Freston, J, additional, Kaplowitz, N, additional, Mann, J, additional, Petrie, J, additional, Perrone, S, additional, Nicholls, S, additional, Janssens, S, additional, Bocchi, E, additional, Giannetti, N, additional, Verma, S, additional, Zhang, J, additional, Spinar, J, additional, Seronde, M-F, additional, Boehm, M, additional, Merkely, B, additional, Chopra, V, additional, Senni, M, additional, Taddi, S, additional, Tsutsui, H, additional, Choi, D-J, additional, Chuquiure, E, additional, La Rocca, HPB, additional, Ponikowski, P, additional, Juanatey, JRG, additional, Squire, I, additional, Januzzi, J, additional, Pina, I, additional, Bernstein, R, additional, Cheung, A, additional, Green, J, additional, Kaul, S, additional, Lam, C, additional, Lip, G, additional, Marx, N, additional, McCullough, P, additional, Mehta, C, additional, Rosenstock, J, additional, Sattar, N, additional, Scirica, B, additional, Shah, S, additional, Wanner, C, additional, Aizenberg, D, additional, Cartasegna, L, additional, Colombo Berra, F, additional, Colombo, H, additional, Fernandez Moutin, M, additional, Glenny, J, additional, Alvarez Lorio, C, additional, Anauch, D, additional, Campos, R, additional, Facta, A, additional, Fernandez, A, additional, Ahuad Guerrero, R, additional, Lobo Márquez, L, additional, Leon de la Fuente, RA, additional, Mansilla, M, additional, Hominal, M, additional, Hasbani, E, additional, Najenson, M, additional, Moises Azize, G, additional, Luquez, H, additional, Guzman, L, additional, Sessa, H, additional, Amuchástegui, M, additional, Salomone, O, additional, Perna, E, additional, Piskorz, D, additional, Sicer, M, additional, Perez de Arenaza, D, additional, Zaidman, C, additional, Nani, S, additional, Poy, C, additional, Resk, J, additional, Villarreal, R, additional, Majul, C, additional, Smith Casabella, T, additional, Sassone, S, additional, Liberman, A, additional, Carnero, G, additional, Caccavo, A, additional, Berli, M, additional, Budassi, N, additional, Bono, J, additional, Alvarisqueta, A, additional, Amerena, J, additional, Kostner, K, additional, Hamilton, A, additional, Begg, A, additional, Beltrame, J, additional, Colquhoun, D, additional, Gordon, G, additional, Sverdlov, A, additional, Vaddadi, G, additional, Wong, J, additional, Coller, J, additional, Prior, D, additional, Friart, A, additional, Leone, A, additional, Vervoort, G, additional, Timmermans, P, additional, Troisfontaines, P, additional, Franssen, C, additional, Sarens, T, additional, Vandekerckhove, H, additional, Van De Borne, P, additional, Chenot, F, additional, De Sutter, J, additional, De Vuyst, E, additional, Debonnaire, P, additional, Dupont, M, additional, Pereira Dutra, O, additional, Canani, LH, additional, Vieira Moreira, MdC, additional, de Souza, W, additional, Backes, LM, additional, Maia, L, additional, De Souza Paolino, B, additional, Manenti, ER, additional, Saporito, W, additional, Villaça Guimarães Filho, F, additional, Franco Hirakawa, T, additional, Saliba, LA, additional, Neuenschwander, FC, additional, de Freitas Zerbini, CA, additional, Gonçalves, G, additional, Gonçalves Mello, Y, additional, Ascenção de Souza, J, additional, Beck da Silva Neto, L, additional, Bocchi, EA, additional, Da Silveira, J, additional, de Moura Xavier Moraes Junior, JB, additional, de Souza Neto, JD, additional, Hernandes, M, additional, Finimundi, HC, additional, Sampaio, CR, additional, Vasconcellos, E, additional, Neves Mancuso, FJ, additional, Noya Rabelo, MM, additional, Rodrigues Bacci, M, additional, Santos, F, additional, Vidotti, M, additional, Simões, MV, additional, Gomes, FL, additional, Vieira Nascimento, C, additional, Precoma, D, additional, Helfenstein Fonseca, FA, additional, Ribas Fortes, JA, additional, Leães, PE, additional, Campos de Albuquerque, D, additional, Kerr Saraiva, JF, additional, Rassi, S, additional, Alves da Costa, FA, additional, Reis, G, additional, Zieroth, S, additional, Dion, D, additional, Savard, D, additional, Bourgeois, R, additional, Constance, C, additional, Anderson, K, additional, Leblanc, M-H, additional, Yung, D, additional, Swiggum, E, additional, Pliamm, L, additional, Pesant, Y, additional, Tyrrell, B, additional, Huynh, T, additional, Spiegelman, J, additional, Lavoie, J-P, additional, Hartleib, M, additional, Bhargava, R, additional, Straatman, L, additional, Virani, S, additional, Costa-Vitali, A, additional, Hill, L, additional, Heffernan, M, additional, Khaykin, Y, additional, Ricci, J, additional, Senaratne, M, additional, Zhai, A, additional, Lubelsky, B, additional, Toma, M, additional, Yao, L, additional, McKelvie, R, additional, Noronha, L, additional, Babapulle, M, additional, Pandey, A, additional, Curnew, G, additional, Lavoie, A, additional, 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Published
2022
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8. Evaluation of the effect of sodium–glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced trial

Author

Packer, M, Butler, J, Filippatos, G, Jamal, W, Salsali, A, Schnee, J, Kimura, K, Zeller, C, George, J, Brueckmann, M, Anker, S, Zannad, F, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Verma, S, Jian, Z, Spinar, J, Seronde, M, Bohm, M, Merkely, B, Chopra, V, Senni, M, Taddei, S, Tsutsui, H, Choi, D, Chuquiure, E, La Rocca, H, Ponikowski, P, Juanatey, J, Squire, I, Januzzi, J, Pina, I, Pocock, S, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, M, Bernstein, R, Cheung, A, Green, J, Kaul, S, Ping, C, Lip, G, Marx, N, Mccullough, P, Mehta, C, Rosenstock, J, Sattar, N, Scirica, B, Wanner, C, Welty, F, Parhofer, K, Clayton, T, Pedersen, T, Lees, K, Konstam, M, Greenberg, B, Palmer, M, Packer M., Butler J., Filippatos G. S., Jamal W., Salsali A., Schnee J., Kimura K., Zeller C., George J., Brueckmann M., Anker S. D., Zannad F., Perrone S., Nicholls S., Janssens S., Bocchi E., Giannetti N., Verma S., Jian Z., Spinar J., Seronde M. -F., Bohm M., Merkely B., Chopra V., Senni M., Taddei S., Tsutsui H., Choi D. -J., Chuquiure E., La Rocca H. P. B., Ponikowski P., Juanatey J. R. G., Squire I., Januzzi J., Pina I., Pocock S. J., Carson P., Doehner W., Miller A., Haas M., Pehrson S., Komajda M., Anand I., Teerlink J., Rabinstein A., Steiner T., Kamel H., Tsivgoulis G., Lewis J., Freston J., Kaplowitz N., Mann J., Petrie M., Bernstein R., Cheung A., Green J., Kaul S., Ping C. L. S., Lip G., Marx N., McCullough P., Mehta C., Rosenstock J., Sattar N., Scirica B., Wanner C., Welty F. K., Parhofer K. G., Clayton T., Pedersen T. R., Lees K. R., Konstam M. A., Greenberg B., Palmer M., Packer, M, Butler, J, Filippatos, G, Jamal, W, Salsali, A, Schnee, J, Kimura, K, Zeller, C, George, J, Brueckmann, M, Anker, S, Zannad, F, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Verma, S, Jian, Z, Spinar, J, Seronde, M, Bohm, M, Merkely, B, Chopra, V, Senni, M, Taddei, S, Tsutsui, H, Choi, D, Chuquiure, E, La Rocca, H, Ponikowski, P, Juanatey, J, Squire, I, Januzzi, J, Pina, I, Pocock, S, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, M, Bernstein, R, Cheung, A, Green, J, Kaul, S, Ping, C, Lip, G, Marx, N, Mccullough, P, Mehta, C, Rosenstock, J, Sattar, N, Scirica, B, Wanner, C, Welty, F, Parhofer, K, Clayton, T, Pedersen, T, Lees, K, Konstam, M, Greenberg, B, Palmer, M, Packer M., Butler J., Filippatos G. S., Jamal W., Salsali A., Schnee J., Kimura K., Zeller C., George J., Brueckmann M., Anker S. D., Zannad F., Perrone S., Nicholls S., Janssens S., Bocchi E., Giannetti N., Verma S., Jian Z., Spinar J., Seronde M. -F., Bohm M., Merkely B., Chopra V., Senni M., Taddei S., Tsutsui H., Choi D. -J., Chuquiure E., La Rocca H. P. B., Ponikowski P., Juanatey J. R. G., Squire I., Januzzi J., Pina I., Pocock S. J., Carson P., Doehner W., Miller A., Haas M., Pehrson S., Komajda M., Anand I., Teerlink J., Rabinstein A., Steiner T., Kamel H., Tsivgoulis G., Lewis J., Freston J., Kaplowitz N., Mann J., Petrie M., Bernstein R., Cheung A., Green J., Kaul S., Ping C. L. S., Lip G., Marx N., McCullough P., Mehta C., Rosenstock J., Sattar N., Scirica B., Wanner C., Welty F. K., Parhofer K. G., Clayton T., Pedersen T. R., Lees K. R., Konstam M. A., Greenberg B., and Palmer M.

Abstract

Drugs that inhibit the sodium–glucose co-transporter 2 (SGLT2) have been shown to reduce the risk of hospitalizations for heart failure in patients with type 2 diabetes. In populations that largely did not have heart failure at the time of enrolment, empagliflozin, canagliflozin and dapagliflozin decreased the risk of serious new-onset heart failure events by ≈30%. In addition, in the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of both pump failure and sudden deaths, the two most common modes of death among patients with heart failure. In none of the three trials could the benefits of SGLT2 inhibitors on heart failure be explained by the actions of these drugs as diuretics or anti-hyperglycaemic agents. These observations raise the possibility that SGLT2 inhibitors could reduce morbidity and mortality in patients with established heart failure, including those without diabetes. The EMPEROR-Reduced trial is enrolling ≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤ 40%), half of whom are expected not to have diabetes. Patients are being randomized to placebo or empagliflozin 10 mg daily, which is added to all appropriate treatment with inhibitors of the renin–angiotensin system and neprilysin, beta-blockers and mineralocorticoid receptor antagonists. The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events. By adjusting eligibility based on natriuretic peptide levels to the baseline ejection fraction, the trial will preferentially enrol high-risk patients. A large proportion of the participants is expected to have an ejection fraction < 30%, and the estimated annual event rate is expected to be at least 15%. The EMPEROR-Reduced trial is well-positioned to determine if the addi

Published
2019

9. Evaluation of the effects of sodium–glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-Preserved Trial

Author

Anker, S, Butler, J, Filippatos, G, Jamal, W, Salsali, A, Schnee, J, Kimura, K, Zeller, C, George, J, Brueckmann, M, Zannad, F, Packer, M, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Verma, S, Jian, Z, Gomez Mesa, J, Spinar, J, Bohm, M, Merkely, B, Chopra, V, Senni, M, Taddi, S, Tsutsui, H, Chuquiure, E, La Rocca, H, Ponikowski, P, Vinereanu, D, Sim, D, Choi, D, Juanatey, J, Squire, I, Januzzi, J, Pina, I, Pocock, S, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, M, Bernstein, R, Cheung, A, Green, J, Kaul, S, Ping, C, Lip, G, Marx, N, Mccullough, P, Mehta, C, Rosenstock, J, Sattar, N, Scirica, B, Wanner, C, Welty, F, Parhofer, K, Clayton, T, Pedersen, T, Lees, K, Konstam, M, Greenberg, B, Palmer, M, Anker S. D., Butler J., Filippatos G. S., Jamal W., Salsali A., Schnee J., Kimura K., Zeller C., George J., Brueckmann M., Zannad F., Packer M., Perrone S., Nicholls S., Janssens S., Bocchi E., Giannetti N., Verma S., Jian Z., Gomez Mesa J. E., Spinar J., Bohm M., Merkely B., Chopra V., Senni M., Taddi S., Tsutsui H., Chuquiure E., La Rocca H. P. B., Ponikowski P., Vinereanu D., Sim D., Choi D. -J., Juanatey J. R. G., Squire I., Januzzi J., Pina I., Pocock S. J., Carson P., Doehner W., Miller A., Haas M., Pehrson S., Komajda M., Anand I., Teerlink J., Rabinstein A., Steiner T., Kamel H., Tsivgoulis G., Lewis J., Freston J., Kaplowitz N., Mann J., Petrie M., Bernstein R., Cheung A., Green J., Kaul S., Ping C. L. S., Lip G., Marx N., McCullough P., Mehta C., Rosenstock J., Sattar N., Scirica B., Wanner C., Welty F. K., Parhofer K. G., Clayton T., Pedersen T. R., Lees K. R., Konstam M. A., Greenberg B., Palmer M., Anker, S, Butler, J, Filippatos, G, Jamal, W, Salsali, A, Schnee, J, Kimura, K, Zeller, C, George, J, Brueckmann, M, Zannad, F, Packer, M, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Verma, S, Jian, Z, Gomez Mesa, J, Spinar, J, Bohm, M, Merkely, B, Chopra, V, Senni, M, Taddi, S, Tsutsui, H, Chuquiure, E, La Rocca, H, Ponikowski, P, Vinereanu, D, Sim, D, Choi, D, Juanatey, J, Squire, I, Januzzi, J, Pina, I, Pocock, S, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, M, Bernstein, R, Cheung, A, Green, J, Kaul, S, Ping, C, Lip, G, Marx, N, Mccullough, P, Mehta, C, Rosenstock, J, Sattar, N, Scirica, B, Wanner, C, Welty, F, Parhofer, K, Clayton, T, Pedersen, T, Lees, K, Konstam, M, Greenberg, B, Palmer, M, Anker S. D., Butler J., Filippatos G. S., Jamal W., Salsali A., Schnee J., Kimura K., Zeller C., George J., Brueckmann M., Zannad F., Packer M., Perrone S., Nicholls S., Janssens S., Bocchi E., Giannetti N., Verma S., Jian Z., Gomez Mesa J. E., Spinar J., Bohm M., Merkely B., Chopra V., Senni M., Taddi S., Tsutsui H., Chuquiure E., La Rocca H. P. B., Ponikowski P., Vinereanu D., Sim D., Choi D. -J., Juanatey J. R. G., Squire I., Januzzi J., Pina I., Pocock S. J., Carson P., Doehner W., Miller A., Haas M., Pehrson S., Komajda M., Anand I., Teerlink J., Rabinstein A., Steiner T., Kamel H., Tsivgoulis G., Lewis J., Freston J., Kaplowitz N., Mann J., Petrie M., Bernstein R., Cheung A., Green J., Kaul S., Ping C. L. S., Lip G., Marx N., McCullough P., Mehta C., Rosenstock J., Sattar N., Scirica B., Wanner C., Welty F. K., Parhofer K. G., Clayton T., Pedersen T. R., Lees K. R., Konstam M. A., Greenberg B., and Palmer M.

Abstract

Background: The principal biological processes that characterize heart failure with a preserved ejection fraction (HFpEF) are systemic inflammation, epicardial adipose tissue accumulation, coronary microcirculatory rarefaction, myocardial fibrosis and vascular stiffness; the resulting impairment of left ventricular and aortic distensibility (especially when accompanied by impaired glomerular function and sodium retention) causes increases in cardiac filling pressures and exertional dyspnoea despite the relative preservation of left ventricular ejection fraction. Independently of their actions on blood glucose, sodium–glucose co-transporter 2 (SGLT2) inhibitors exert a broad range of biological effects (including actions to inhibit cardiac inflammation and fibrosis, antagonize sodium retention and improve glomerular function) that can ameliorate the pathophysiological derangements in HFpEF. Such SGLT2 inhibitors exert favourable effects in experimental models of HFpEF and have been found in large-scale trials to reduce the risk for serious heart failure events in patients with type 2 diabetes, many of whom were retrospectively identified as having HFpEF. Study design: The EMPEROR-Preserved Trial is enrolling ≈5750 patients with HFpEF (ejection fraction >40%), with and without type 2 diabetes, who are randomized to receive placebo or empagliflozin 10 mg/day, which is added to all appropriate treatments for HFpEF and co-morbidities. Study aims: The primary endpoint is the time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure. The trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death,. all-cause mortality and recurrent hospitalization events, and will assess a wide range of biomarkers that reflect important pathophysiological mechanisms that may drive the evolution of HFpEF. The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningfu

Published
2019

13. Evaluation of the effects of sodium–glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-Preserved Trial

Author

Anker, S.D. Butler, J. Filippatos, G.S. Jamal, W. Salsali, A. Schnee, J. Kimura, K. Zeller, C. George, J. Brueckmann, M. Zannad, F. Packer, M. Packer, M. Butler, J. Filippatos, G.S. Zannad, F. George, J. Brueckmann, M. Perrone, S. Nicholls, S. Janssens, S. Bocchi, E. Giannetti, N. Verma, S. Jian, Z. Gomez Mesa, J.E. Spinar, J. Böhm, M. Merkely, B. Chopra, V. Senni, M. Taddi, S. Tsutsui, H. Chuquiure, E. La Rocca, H.P.B. Ponikowski, P. Vinereanu, D. Sim, D. Choi, D.-J. Juanatey, J.R.G. Squire, I. Butler, J. Januzzi, J. Pina, I. Pocock, S.J. Carson, P. Doehner, W. Miller, A. Haas, M. Pehrson, S. Komajda, M. Anand, I. Teerlink, J. Rabinstein, A. Steiner, T. Kamel, H. Tsivgoulis, G. Lewis, J. Freston, J. Kaplowitz, N. Mann, J. Petrie, M. Bernstein, R. Cheung, A. Green, J. Januzzi, J. Kaul, S. Ping, C.L.S. Lip, G. Marx, N. McCullough, P. Mehta, C. Rosenstock, J. Sattar, N. Scirica, B. Tsutsui, H. Wanner, C. Welty, F.K. Parhofer, K.G. Clayton, T. Pedersen, T.R. Lees, K.R. Konstam, M.A. Greenberg, B. Palmer, M. the EMPEROR-Preserved Trial Committees Investigators

Abstract

Background: The principal biological processes that characterize heart failure with a preserved ejection fraction (HFpEF) are systemic inflammation, epicardial adipose tissue accumulation, coronary microcirculatory rarefaction, myocardial fibrosis and vascular stiffness; the resulting impairment of left ventricular and aortic distensibility (especially when accompanied by impaired glomerular function and sodium retention) causes increases in cardiac filling pressures and exertional dyspnoea despite the relative preservation of left ventricular ejection fraction. Independently of their actions on blood glucose, sodium–glucose co-transporter 2 (SGLT2) inhibitors exert a broad range of biological effects (including actions to inhibit cardiac inflammation and fibrosis, antagonize sodium retention and improve glomerular function) that can ameliorate the pathophysiological derangements in HFpEF. Such SGLT2 inhibitors exert favourable effects in experimental models of HFpEF and have been found in large-scale trials to reduce the risk for serious heart failure events in patients with type 2 diabetes, many of whom were retrospectively identified as having HFpEF. Study design: The EMPEROR-Preserved Trial is enrolling ≈5750 patients with HFpEF (ejection fraction >40%), with and without type 2 diabetes, who are randomized to receive placebo or empagliflozin 10 mg/day, which is added to all appropriate treatments for HFpEF and co-morbidities. Study aims: The primary endpoint is the time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure. The trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death,. all-cause mortality and recurrent hospitalization events, and will assess a wide range of biomarkers that reflect important pathophysiological mechanisms that may drive the evolution of HFpEF. The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options. © 2019 The Authors. European Journal of Heart Failure © 2019 European Society of Cardiology

Published
2019

14. Evaluation of the effect of sodium–glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced trial

Author

Packer, M. Butler, J. Filippatos, G.S. Jamal, W. Salsali, A. Schnee, J. Kimura, K. Zeller, C. George, J. Brueckmann, M. Anker, S.D. Zannad, F. Butler, J. Zannad, F. George, J. Brueckmann, M. Perrone, S. Nicholls, S. Janssens, S. Bocchi, E. Giannetti, N. Verma, S. Jian, Z. Spinar, J. Seronde, M.-F. Böhm, M. Merkely, B. Chopra, V. Senni, M. Taddei, S. Tsutsui, H. Choi, D.-J. Chuquiure, E. La Rocca, H.P.B. Ponikowski, P. Juanatey, J.R.G. Squire, I. Butler, J. Januzzi, J. Pina, I. Pocock, S.J. Carson, P. Doehner, W. Miller, A. Haas, M. Pehrson, S. Komajda, M. Anand, I. Teerlink, J. Rabinstein, A. Steiner, T. Kamel, H. Tsivgoulis, G. Lewis, J. Freston, J. Kaplowitz, N. Mann, J. Petrie, M. Bernstein, R. Cheung, A. Green, J. Januzzi, J. Kaul, S. Ping, C.L.S. Lip, G. Marx, N. McCullough, P. Mehta, C. Rosenstock, J. Sattar, N. Scirica, B. Tsutsui, H. Wanner, C. Welty, F.K. Parhofer, K.G. Clayton, T. Pedersen, T.R. Lees, K.R. Konstam, M.A. Greenberg, B. Palmer, M. the EMPEROR-Reduced Trial Committees Investigators Executive Committee National Coordinators Consulting Statistician Clinical Events Committee Scientific Excellence Committee Data Monitoring Committee

Abstract

Drugs that inhibit the sodium–glucose co-transporter 2 (SGLT2) have been shown to reduce the risk of hospitalizations for heart failure in patients with type 2 diabetes. In populations that largely did not have heart failure at the time of enrolment, empagliflozin, canagliflozin and dapagliflozin decreased the risk of serious new-onset heart failure events by ≈30%. In addition, in the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of both pump failure and sudden deaths, the two most common modes of death among patients with heart failure. In none of the three trials could the benefits of SGLT2 inhibitors on heart failure be explained by the actions of these drugs as diuretics or anti-hyperglycaemic agents. These observations raise the possibility that SGLT2 inhibitors could reduce morbidity and mortality in patients with established heart failure, including those without diabetes. The EMPEROR-Reduced trial is enrolling ≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤ 40%), half of whom are expected not to have diabetes. Patients are being randomized to placebo or empagliflozin 10 mg daily, which is added to all appropriate treatment with inhibitors of the renin–angiotensin system and neprilysin, beta-blockers and mineralocorticoid receptor antagonists. The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events. By adjusting eligibility based on natriuretic peptide levels to the baseline ejection fraction, the trial will preferentially enrol high-risk patients. A large proportion of the participants is expected to have an ejection fraction < 30%, and the estimated annual event rate is expected to be at least 15%. The EMPEROR-Reduced trial is well-positioned to determine if the addition of empagliflozin can add meaningfully to current approaches that have established benefits in the treatment of chronic heart failure with left ventricular systolic dysfunction. © 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Published
2019

21. Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease

Author

Torres, Vicente E., Chapman, Arlene B., Devuyst, Olivier, Gansevoort, Ron T., Perrone, Ronald D., Koch, Gary, Ouyang, John, Mcquade, Robert D., Blais, Jaime D., Czerwiec, Frank S., Sergeyeva, Olga, Reprise, Trial Investigators, Cowley, B., Goldstein, S., Chertow, G., Wei, L., Alpers, D. H., Freston, J., Lewis, J. H., Hunt, C. M., La Fuente, J., Vallejos, A., Beresan, H. M., Diaz, H. C., Wasserman, A., Martin, R. S., Rial, M., Cusumano, A. M., Novoa, P. A., Mele, P., Raffaele, P., Fraser, I., Rangan, G., Mathew, M., Cooper, B., Faull, R., Holt, S., Snelling, P., Jardine, M., Thomas, M., Packham, D., Vilayur, E., Johnson, D., Niepen, P., Peeters, P., Bammens, B., Warling, X., Vlem, B., Doubel, P., Hellemans, R., Bichet, D., Pei, Y., Chow, S., Mcmahon, A., Murphy, S., Mcfarlane, P., Ting, R., Tesar, V., Ryba, M., Peskova, M., Oplustilova, A., Dusilova Sulkova, S., Tocik, J., Suchanova, J., Viklicky, O., Rehorova, J., Valkovsky, I., Dieperink, H., Birn, H., Bech, J., Christensen, J., Zaoui, P., Pouteil-Noble, C., Combe, C., Kessler, M., Lemeur, Y., Mariat, C., Chauveau, D., Laville, M., Rieu, P., Fauvel, J. P., Dellanna, F., Gross, P., Renders, L., Budde, K., Sommerer, C., Strutz, F., Hugo, C., Guberina, H., Leidig, M., Csiky, B., Haris, A., Ondrik, Z., Kukuy, O., Ben-Dov, I., Yagil, Y., Schwartz, D., Dijk, D., Kristal, B., Capasso, G., Capelli, G., Cerutti, R., Esposito, C., Frascà, G., Gesualdo, L., Mancini, E., Manunta, P., Pontoriero, G., Scolari, F., Drenth, J., Apeland, T., Marti, H. P., Stenehjem, A., Klatko, W., Klinger, M., Ksiazek, A., Malecki, R., Nowicki, M., Sulowicz, W., Bako, G., Achim, C., Dragulete, R., Marasaev, V., Nagibovich, O., Rossovskaya, M., Esayan, A., Rayner, B., Latiff, G., Muranda, A., Peces Serrano, R., Nieto Iglesias, J., Hueso Val, M., Praga Terente, M., Castro Alonso, C., Guron, G., Melin, J., Heimbürger, O., Fernström, A., Hellberg, O., Turner, N., D Souza, R., Barratt, J., Mikhail, A., Howse, M., Sayer, J., Shipley, T., Takats, D., sunil bhandari, Ong, A., Hillman, K., Vilar, E., Wood, G., Gale, D., Kingswood, J., Ayub, W., Lambie, S., Al-Saghir, F., Bai, L., Price, D., Dilley, J., Blumenfeld, J., Scott, D., Sothinathan, R., Mehta, B., Kaveh, K., Dahl, N., Haastrup, A., Kopyt, N., Harper, K., Ross, D., El-Shahawy, M., Nachman, P., Bellovich, K., Shirazian, S., Bart, S., Fadem, S., Watnick, T., Oo, T., Rastogi, A., Silva, A., Sullivan, J., Thomas, J., Mrug, M., Nossuli, A., Mcgreal, K., Hariachar, S., Umanath, K., Vernace, M., Rosner, M., Newman, G., Levitski-Heikkila, T., Smith, M., Schmidt, R., Reddy, B., Linfert, D., Roppolo, M., Edelstein, C., Rahbari Oskoui, F., Chonchol, M., Germain, M., Gupta, A., Kant, K., Goldberg, S., Mordujovich, J., Moustafa, M., Lifland, H., Cangiano, J., Visger, J., Negrea, L., Berg, J., Culpepper, M., Goral, S., Radhakrishnan, J., Navarro, J., Ryu, J., Burgner, A., Solomon, R., Venuto, R., Pisoni, R., Charen, E., Chuang, P., Mangoo-Karim, R., Lioudis, M., Cohen, R., Park, M., Delong, M., Siddiqi, S., Bodell, M., Mccune, T., Mandayam, S., Foringer, J., Raina, R., Pitone, J., Quadrini, M., Nwakoby, I., Vo, N., and Liss, K.

Published
2017

23. Should we eradicate Helicobacter pylori before long term antireflux therapy?

Author

Freston, J W.

Subjects
Helicobacter infections -- Drug therapy, Gastroesophageal reflux -- Drug therapy, Proton pump inhibitors -- Evaluation, Health, Drug therapy, Evaluation
Abstract

Patient management recommendations that might become health care policy should be based on the highest level of evidence. The evidence supporting the recommendation to 'test and treat' for Helicobacter pylori [...]

Published
2001

26. Do children with gastroesophageal reflux become adults with gastroesophageal reflux? What is the role of Acid suppression in children?

Author

Werlin Sl, Boyle Jt, Co J, Tolia, Freston J, Davidson G, and Nelson S

Subjects
Adult, medicine.medical_specialty, Aging, business.industry, Gastroenterology, Reflux, Hydrogen-Ion Concentration, Gastric Acid, Acid suppression, Gastrointestinal Agents, Internal medicine, Pediatrics, Perinatology and Child Health, Chronic Disease, Gastroesophageal Reflux, Medicine, Humans, business, Child
Published
2003

35. Decision-making in dyspepsia

Author

Tytgat, G., primary, Hungin, A. P. S., additional, Malfertheiner, P., additional, Talley, N., additional, Hongo, M., additional, McColl, K., additional, Soule, J. -C., additional, Agréus, L., additional, Bianchi-Porro, G., additional, Freston, J., additional, and Hunt, R., additional

Published
1999
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39. Rationalizing cyclooxygenase (COX) inhibition for maximal efficacy and minimal adverse events.

Author

Freston, James W. and Freston, J W

Subjects
*CYCLOOXYGENASES, *NONSTEROIDAL anti-inflammatory agents, *CHEMICAL inhibitors, *DRUG side effects, *DRUG therapy for arthritis, *CLINICAL trials, *DIGESTIVE organs, *DOSE-effect relationship in pharmacology, *ENZYME inhibitors, *INDIGESTION, *ISOENZYMES, *KETONES, *LIFE expectancy, *MEMBRANE proteins, *META-analysis, *OXIDOREDUCTASES, *STATISTICS, *CYCLOOXYGENASE 2, *RELATIVE medical risk, *DISEASE incidence, *ODDS ratio, *THERAPEUTICS
Abstract

New information indicates that cyclooxygenase-2 (COX-2) is constitutively expressed in several tissues, including brain, lung, pancreas, kidney, and ovary, and plays an important role in renal and gastrointestinal function. Selective COX-2 inhibition has been associated in animal studies with impairment of ulcer healing and renal function and inhibition of prostacyclin, an effect that inhibits vasodilation without inhibiting platelet aggregation. The clinical consequences, if any, of these effects remain to be determined in long-term studies in humans. The premise that selective COX-2 inhibitors will cause less gastrointestinal toxicity than nonsteroidal antiinflammatory drugs that inhibit both COX isoforms needs to take into account the low toxicity of nabumetone. The gastrointestinal safety profile of this nonacidic, dual COX inhibitor that does not undergo enterohepatic circulation has been evaluated in extensive clinical trials. The data submitted to the US Food and Drug Administration in the New Drug Application for nabumetone (Relafen), the comparative trials subsequently completed, the published databases of the comparative gastrointestinal toxicity of various nonsteroidal anti-inflammatory drugs (NSAIDs), and the meta-analysis published in this issue of The American Journal of Medicine (Schoenfeld, page 48S) indicate that nabumetone has the lowest incidence of gastrointestinal toxicity among the extensively studied NSAIDs. Overall, the incidence is approximately 10-fold less than with comparator drugs. This rate is an appropriate current reference against which the gastrointestinal toxicity of COX-2 inhibitors can be compared. [ABSTRACT FROM AUTHOR]

Published
1999
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40. Suppression of immune responsiveness by a submandibular salivary gland factor.

Author

Roberts, M. L., Freston, J. A., and Reade, P. C.

Subjects
*TISSUE extracts, *SUBMANDIBULAR gland, *EPIDERMAL growth factor, *LABORATORY mice, *ALLERGY in animals, *IMMUNE response
Abstract

Both tissue extracts prepared from submandibular salivary glands of male mice and epidermal growth factor isolated from these glands depressed the delayed type hypersensitivity response to 2,4-dinitro-1-fluorobenzene in mice. Extirpation of the submandibular salivary glands from male mice did not alter the delayed type hypersensitivity response. The role of salivary gland factors, particularly epidermal growth factor, in influencing the immune response has been discussed. [ABSTRACT FROM AUTHOR]

Published
1976

48. Triple Versus Dual Therapy for Eradicating Helicobacter pylori and Preventing Ulcer Recurrence: A Randomized, Double- Blind, Multicenter Study of Lansoprazole, Clarithromycin, and/ or Amoxicillin in Different Dosing Regimens.

Author

Schwartz, H., Krause, R., Sahba, B., Haber, M., Weissfeld, A., Rose, P., Siepman, N., and Freston, J.

Subjects
DRUG efficacy, PROTON pump inhibitors, ANTIBIOTICS, HELICOBACTER pylori, DUODENAL ulcers, THERAPEUTICS
Abstract

Objective: The efficacy and safety of dual and triple therapies with a proton pump inhibitor and antibiotic(s) for therapy of Helicobacter pylori-associated duodenal ulcer disease have been compared using results from independent studies using different methods and regimens, making interpretation difficult. In a large, double-blind, multicenter study conducted in the United States, we compared a triple therapy regimen with four dual therapy and one monotherapy regimens in the eradication of H. pylori and the prevention of ulcer recurrence. Methods: Patients with active duodenal ulcer disease or history of duodenal ulcer disease within the past year and H. pylori infection were randomized to receive one of six 14-day treatment regimens: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 gm b.i.d.; lansoprazole 30 mg b.i.d. and either clarithromycin 500 mg b.i.d. or t.i.d.; lansoprazole 30 mg b.i.d. or t.i.d. with amoxicillin 1 gm t.i.d.; or lansoprazole 30 mg t.i.d. alone. No additional acid suppression therapy followed eradication therapy. Primary efficacy endpoints were eradication of H. pylori and ulcer recurrence. Results: Of 396 patients enrolled in the study, 352 met the entry criteria for duodenal ulcer status and H. pylori positivity. At 4-6 wk after the end of therapy, H. pylori was eradicated from 94% (44 of 47) of patients receiving lansoprazole, clarithromycin, and amoxicillin triple therapy, 77% (39 of 51) of those receiving lansoprazole t.i.d./amoxicillin t.i.d., 75% (36 of 48) of those receiving lansoprazole b.i.d./clarithromycin t.i.d., 57% (28 of 49) of those receiving lansoprazole b.i.d./clarithromycin b.i.d., 53% (26 of 49) of those receiving lansoprazole b.i.d./amoxicillin t.i.d., and 2% (1 of 53) of those receiving lansoprazole monothera... [ABSTRACT FROM AUTHOR]

Published
1998
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49. Cimetidine: II. Adverse reactions and patterns of use.

Author

Freston, J W

Subjects
BLOOD diseases, CARDIOVASCULAR diseases, CENTRAL nervous system diseases, CIMETIDINE, DRUG interactions, DRUG utilization, ENDOCRINE diseases, IMMUNITY, KIDNEY diseases, ORGANIC compounds, STOMACH tumors
Abstract

Numerous adverse reactions have been attributed to cimetidine, which is understandable in view of the attention and scrutiny the drug has received, its widespread use, and its systemic effects. The reported frequency of side effects has differed considerably but is surprisingly low in all studies. The drug has caused an array of central nervous system disturbances, gynecomastia, and, rarely, hepatotoxicity, interstitial nephritis, bradycardia, hypotension, and even cardiac arrest. The last complication has occurred with rapid-bolus intravenous injection. Blood dyscrasias have also been rare and usually associated with serious underlying disease or multiple drugs, making it difficult to establish cause and effect in most cases. The drug is used widely to treatment conditions for which it is not approved. Some of these conditions are now believed to respond to cimetidine (gastric ulcer); others are known not to respond (acute upper gastrointestinal bleeding and acute pancreatitis). [ABSTRACT FROM AUTHOR]

Published
1982
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