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Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME (R) trial
- Authors
- Fitchett, David; Zinman, Bernard; Wanner, Christoph; Lachin, John M.; Hantel, Stefan; Salsali, Afshin; Johansen, Odd Erik; Woerle, Hans J.; Broedl, Uli C.; Inzucchi, Silvio E.; EMPA-REG OUTCOME trial investiors; Aizenberg, D.; Ulla, M.; Waitman, J.; De Loredo, L.; Farias, J.; Fideleff, H.; Lagrutta, M.; Maldonado, N.; Colombo, H.; Ferre Pacora, F.; Wasserman, A.; Maffei, L.; Lehman, R.; Selvanayagam, J.; d'Emden, M.; Fasching, P.; Paulweber, B.; Toplak, H.; Luger, A.; Drexel, H.; Prager, R.; Schnack, C.; Schernthaner, G.; Fliesser-Goerzer, E.; Kaser, S.; Scheen, A.; Van Gaal, L.; Hollanders, G.; Kockaerts, Y.; Capiau, L.; Chachati, A.; Persu, A.; Hermans, M.; Vantroyen, D.; Vercammen, C.; Van de Borne, P.; Mathieu, C.; Benhalima, K.; Lienart, F.; Mortelmans, J.; Strivay, M.; Vereecken, G.; Keymeulen, B.; Lamkanfi, F.; Chacra, A.; Eliaschewitz, F.; Zanella, M.; Faludi, A.; Bertolami, M.; Hayashida, C.; Nunes Salles, J.; Monte, O.; Dinato, M.; Manenti, E.; Rassi, N.; Halpern, A.; Lima Filho, M.; Ayoub, J.; Felicio, J.; Borges, J.; Gross, J.; Sgarbi, J.; Betti, R.; Tiburcio, A.; Purisch, S.; Schmid, H.; Takahashi, M.; Castro, M.; Rea, R.; Hissa, M.; Geloneze Neto, B.; Saraiva, J.; Henein, S.; Lochnan, H.; Imran, S. A.; Clayton, D.; Bayly, K.; Berlingieri, J.; Boucher, P.; Chan, Y.; Gupta, M.; Chehayeb, R.; Ouellett, A.; Ur, E.; Woo, V.; Zinman, B.; St Amour, E.; Terront Lozano, M.; Yupanqui Lozno, H.; Urina, M.; Lopez Jaramillo, P.; Jaramillo, N.; Sanchez, G.; Perez, G.; Tusek, S.; Mirosevic, G.; Goldoni, V.; Jurisic-Erzen, D.; Balasko, A.; Balic, S.; Drvodelic-Sunic, E.; Varzic, S. Canecki; Machkova, M.; Weiner, P.; Lastuvka, J.; Olsovsky, J.; Krarup, T.; Ridderstrale, M.; Tarnow, L.; Boesgaard, T. Wellov; Lihn, A. Saetre; Christensen, P.; Juhl, H.; Urhammer, S.; Lund, P.; Adojaan, B.; Jakovlev, U.; Lanno, R.; Lubi, M.; Marandi, T.; Gouet, D.; Courreges, J.; Zaoui, P.; Choukroun, G.; Petit, C.; Formagne, L.; Estour, B.; Mabire, P.; Daugenet, C.; Lemarie, B.; Clavel, S.; Aure, P.; Remaud, P.; Halimi, J.; Hadjadj, S.; Couffinhal, T.; Glonti, S.; Metreveli, D.; Lominadze, Z.; Giorgadze, E.; Burtchuladze, T.; Javashvili, L.; Kurashvili, G.; Kurashvili, R.; Virsaladze, D.; Nadareishvili, L.; Khomasuridze, A.; Cahill, T.; Green, F.; MacRury, S.; Waldron, M.; Middleton, A.; McKnight, J.; Pearson, E.; Butler, M.; Choksi, M.; Caldwell, I.; Farmer, I.; Wyatt, N.; Patrick, J.; O'Brien, I.; Devers, M.; Bousboulas, S.; Pappas, S.; Piaditis, G.; Vryonidou, A.; Tentolouris, N.; Karamitsos, K.; Manes, C.; Benroubi, M.; Avramidis, I.; Ozaki, R.; Tan, K.; Siu, S.; Tsang, C.; Dudas, M.; Nagy, K.; Salamon, C.; Ip, T.; Geroo, L.; Patkay, J.; Tabak, A.; Juhasz, F.; Szentpeteri, I.; Tamas, G.; Ghaisas, N.; Bantwal, G.; Mohan, V.; Gupta, J.; Sadhu, N.; Kulkarni, A.; Garg, N.; Reddy, S.; Deshpande, N.; Gutlapalli, K.; Pillai, M.; Premchand, R.; Badgandi, M.; Jain, S.; Aravind, S.; Shamanna, P.; Pandey, A.; Gupta, S.; Pramono, B.; Saksono, H. Dante; Agung, P.; Wahono, S. Djoko; Suastika, K.; Tanggo, Y.; Juwana, Y.; Siswanto, B.; Adawi, F.; Efrati, S.; Mazen, E.; Bashkin, A.; Herskovits, T.; Jaffe, A.; Schiff, E.; Wainstein, J.; Taddei, S.; Aiello, A.; Arca, M.; Calabro, P.; Cignarelli, M.; Fioretto, P.; Reggiani, G. Marchesini; Gnasso, A.; Marchionni, N.; Marsilii, A.; Bucci, M.; Mezzetti, A.; Pozzilli, P.; Colivicchi, F.; Santini, M.; Moro, E.; Toscano, V.; Fucili, A.; Semplicini, A.; Monno, S.; Furui, K.; Higashiue, S.; Hiramatsu, N.; Kawamitsu, K.; Takenaka, T.; Takahashi, H.; Hojo, F.; Onishi, Y.; Izumino, K.; Okubo, M.; Wakida, Y.; Kondo, Y.; Hieshima, K.; Jinnouchi, H.; Suzuki, A.; Ito, M.; Park, S.; Kim, Y.; Hong, T.; Park, H.; Gwon, H.; Kim, H.; Kang, K.; Jeong, M.; Seung, K.; Lim, D.; Rha, S.; Tahk, S.; Yang, J.; Yoon, J.; Shin, M.; Kim, D.; Jeong, J.; Ahmad, N. Nik; Mustafa, N.; Mohamed, W. Wan; Fung, Y.; Ghani, R. Abdul; Chandramouli, A.; Chee, K.; Kadir, K. Abdul; Ling, K.; Abu Hassan, M.; Foo, S.; Lee, S.; Garcia Hernandez, P.; Aguilar-Salinas, C.; Vidrio Velazquez, M.; Flores, F.; Alpizar Salazar, M.; Micher Escalante, D.; Garcia Soria, M.; Cardona Munoz, E.; Storms, G.; Schaper, N.; Kooy, A.; Krekels, M.; van Bemmel, T.; Verhoeven, R.; Mulder, H.; Oldenburg-Ligtenberg, P.; Gonkel, F.; de Jong, A.; van Soest, J.; Viergever, P.; Mevissen, H.; Lochorn, G.; Zwiers, G.; Hoogslag, P.; Ronner, E.; Nierop, P.; Al-Windy, N.; Kragten, J.; Dekelver, P.; Benatar, J.; Krebs, J.; Scott, R.; Heggen, E.; Berz, A.; Fossum, C.; Hurtig, U.; Langslet, G.; Baranowski, M.; Sparby, J.; Karlsson, T.; Karlsson, Thomas; Delgado Torres, C.; Rodriguez Escudero, A.; Lisson, R.; Allemant Maldonado, A.; Gallardo Rojas, W.; Gonzales Bravo, L.; Lema Osores, J.; Farfan, J.; Zapata, L.; Godoy Junchaya, J.; Roldan Concha, Y.; Urquiaga Calderon, J.; Sy, R.; Tan, G.; Aquitania, G.; De Los Santos, G.; Panelo, A.; Roderos, O.; Rosales, R.; Toledo, R.; Liwag, A.; Ramoncito, H.; Skokowska, E.; Krzyzagorska, E.; Ogorek, M.; Wojnowski, L.; Spyra, J.; Konieczny, M.; Piesiewicz, W.; Kus, W.; Ocicka-Kozakiewicz, A.; Orlowska-Kunikowska, E.; Zmuda, W.; Duarte, S.; Leitao, A.; Monteiro, P.; Rita, H.; Salgado, V.; Pinto, L.; Queiros, J.; Teixeira, J.; Rogado, C.; Duarte, R.; Sobral do Rosario, F.; Silva, A.; Andrade, L.; Velez, M.; Brazao, M.; Istratoaie, O.; Lichiardopol, R.; Catrinoiu, D.; Militaru, C.; Zetu, C.; Barbonta, D.; Cosma, D.; Crisan, C.; Pop, L.; Esip, V.; Khetagurova, F.; Petrov, A.; Arutyunov, G.; Boyarkin, M.; Agafyina, A.; Vorokhobina, N.; Petunina, N.; Libov, I.; Zalevskaya, A.; Nikolaev, K.; Barbarash, O.; Potemkin, V.; Bystrova, A.; Krasilnikova, E.; Barbarich, V.; Chumakova, G.; Tarasov, N.; Meleshkevich, T.; Zateyshchikov, D.; Lantseva, O.; Belenkiy, D.; Obrezan, A.; Rossolko, L.; Fillipova, E.; Yakhontova, P.; Khokhlov, A.; Tan, R.; Sum, C.; Chang, H.; Distiller, L.; Pretorius, M.; Nortje, H.; Mitha, E.; Burgess, L.; Blignaut, S.; Venter, T.; Moodley, R.; Lombaard, J.; Govind, U.; Naidoo, V.; Mookadam, M.; Engelbrecht, J.; Omar, M.; Jurgens, J.; Podgorski, G.; Vawda, H.; Naidoo, D.; Emanuel, S.; Roodt, A.; Amod, A.; Van Zyl, L.; Segura, J.; Brito, M.; Fernandez-Cruz, A.; Artola, S.; Iglesias, R.; Toural, E.; Garcia-Ortiz, L.; Saban, J.; Mesa, J.; Vidal, J.; Linares, J.; del Canizo, F.; Rigla, M.; Suarez, C.; Llorente, I.; Moreno, B.; Antoli, A.; Gomez Peralta, F.; Iglesias, M.; Pereg, V.; de Teresa, L.; Camafort, M.; Trescoli, C.; Satarasinghe, R.; Somasundaram, N.; Siyambalapitiya, S.; Antonypillai, C.; Bulugahapitiya, D.; Medagama, U.; Huang, C.; Lu, Y.; Hwang, J.; Chiang, C.; Wen, M.; Chen, J.; Lai, W.; Chang, K.; Wang, J.; Yeh, H.; Kriangsak, P.; Deerochanawong, C.; Suwanwalaikorn, S.; Mangklabruks, A.; Kaewsuwanna, P.; Piyayotai, D.; Iabluchanskyi, M.; Samoylov, O.; Godlevska, O.; Kovalyova, O.; Voloshyna, O.; Tseluyko, V.; Zotov, S.; Vykhovanyuk, I.; Dulgeroff, A.; Mayfield, R.; Zaniewski-Singh, M.; Ullal, J.; Aloi, J.; De La Rosa, R.; Mosely, J.; Wittmer, B.; Aronoff, S.; Rosenfeld, J.; Seidner, M.; Warren, M.; Fishman, N.; Weiss, R.; Arif, A.; Sandberg, M.; Lewis, D.; Ball, E.; Graf, R.; Breton, C.; Tamayo, R.; Richards, R.; Cefalu, W.; Uwaifo, G.; Zayour, D.; Hoffman, J.; Fitz-Patrick, D.; Khan, B.; Blaze, K.; Bressler, P.; Halpern, S.; Chappell, D.; Bergenstal, R.; Cuddihy, R.; Matfin, G.; Freedman, Z.; Gonzalez-Campoy, J.; Lerman, S.; Rendell, M.; Sitar, S.; Reeves, M.; Howard, T.; Soufer, J.; Miranda-Palma, B.; Laliotis, A.; Shomali, M.; Teltser, M.; Hurley, D.; Morawski, E.; Cherlin, R.; Houchin, V.; Welch, M.; Goytia-Leos, D.; Syed, M.; Kowaloff, E.; Weinrauch, L.; Peniston, J.; Brockmyre, A.; First, B.; Feld, L.; Huffman, D.; Nassim, O.; Gottschlich, G.; Patel, A.; Knopke, C.; Hernandez, M.; Diaz, J.; Giugliano, G.; Nicasio, J.; Eagerton, D.; Huntley, R.; Reed, J., III; Magee, M.; Hippert, R.; Sofley, C., Jr.; Alzohaili, O.; Levins, P.; Anspach, R.; Shah, S.; Brusco, O.; Naidu, J.; Lindenbaum, J.; Jacks, R.; Hammond, G.; Arena, C.; Saxman, K.; Mach, M.; Kerstein, H.; Kereiakes, D.; Wahlen, J.; Wehmeier, K.; Chaykin, L.; Rothman, J.; Fogelfeld, L.; Stroger, John H., Jr.; Bittar, N.; Rosenstock, J.; Kayne, D.; Navarro, J.; Colfer, H.; Mokshagundam, S.; Shandilya, L.; Connery, L.; Wysham, C.; Dela Llana, A.; Jardula, M.; MacAdams, M.; Flippo, G.; Heurich, E.; Curtis, C.; Sanders, D.; Rawls, R.; Velazquez, F.; Osea, E.; Mahood, K.; Feldman, G.; Eder, F.; Riley, E.; Fowler, W.; Jain, M.; Shepard, M.; Schear, M.; Barker, B.; Strout, C.; Obiekwe, O.; Shanik, M.; Green, C.; Blakney, E.; Roberson, K.; Bretton, E.; Pish, R.; Kaveh, K.; Maynard, B.; Barager, W.; Soldyshev, R.; Austin, B.; Parmar, P.; Simpson, R.; Chauhan, A.; Kasper, J.; Burr, R.; Patel, N.; Mariano, H.; Pluto, T.; Bratcher, C.; Juarez, M.; Levinson, L.; Awad, A.; Longshaw, K.; Hoffman, K.; Richwine, R.; Molter, D.; Boscia, J., III; Kowalyk, S.; Lemis, P.; Liss, J.; Orr, R.; Riser, J.; Wood, J.; Ubani, A.; Paine, W.; Hassani, F.; Miranda, F.; Hansen, V.; Hansen, Val R.; Farris, N.; Bowden, R.; Ajani, D.; Maw, K.; Andersen, J.; Bergman, B.; Dunmyer, S.; Brandon, D.; Anderson, M.; Bononi, P.; Prawer, J.; Seidman, B.; Cruz, H.; Wilks, K.; DiSanto, L.; Buynak, R.; Christensen, T.; Denker, P.; Koppel, W.; Stedman, M.; Lewy-Alterbaum, L.; Karim, S.; Shapiro, J.; Gardner, T.; Oskin, T.; Gabra, N.; Malano, J.
- Issue Date
- May-2016
- Publisher
- Oxford University Press
- Keywords
- Cardiovascular disease; Hospitalization; Mortality
- Citation
- European Heart Journal, v.37, no.19, pp 1526 - 1534
- Pages
- 9
- Indexed
- SCI
SCIE
SCOPUS
- Journal Title
- European Heart Journal
- Volume
- 37
- Number
- 19
- Start Page
- 1526
- End Page
- 1534
- ISSN
- 0195-668X
1522-9645
- Abstract
- Aims We previously reported that in the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure. Methods and results Patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Seven thousand and twenty patients were treated; 706 (10.1%) had heart failure at baseline. Heart failure hospitalization or cardiovascular death occurred in a significantly lower percentage of patients treated with empagliflozin [265/4687 patients (5.7%)] than with placebo [198/2333 patients (8.5%)] [hazard ratio, HR: 0.66 (95% confidence interval: 0.55–0.79); P < 0.001], corresponding to a number needed to treat to prevent one heart failure hospitalization or cardiovascular death of 35 over 3 years. Consistent effects of empagliflozin were observed across subgroups defined by baseline characteristics, including patients with vs. without heart failure, and across categories of medications to treat diabetes and/or heart failure. Empagliflozin improved other heart failure outcomes, including hospitalization for or death from heart failure [2.8 vs. 4.5%; HR: 0.61 (0.47–0.79); P < 0.001] and was associated with a reduction in all-cause hospitalization [36.8 vs. 39.6%; HR: 0.89 (0.82–0.96); P = 0.003]. Serious adverse events and adverse events leading to discontinuation were reported by a higher proportion of patients with vs. without heart failure at baseline in both treatment groups, but were no more common with empagliflozin than with placebo. Conclusion In patients with type 2 diabetes and high cardiovascular risk, empagliflozin reduced heart failure hospitalization and cardiovascular death, with a consistent benefit in patients with and without baseline heart failure.
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Related Researcher
- Rha, Seung Woon
- Guro Hospital (Department of Cardiology, Guro Hospital)