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N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.

Eplerenone in patients with systolic heart failure and mild symptoms.

Collaborators (346)

Drexler H, van Veldhuisen DJ, Krum H, Pitt B, Zannad F, McMurray J, Swedberg K, Remme WJ, Cornel JH, Hildebrandt P, Hradec J, Mareev V, Reddy KS, Sindone A, Martinez F, Alonso Garcia A, Wilhelmsen L, Dargie HJ, Tavazzi L, Pocock S, Leizorovic A, Collier T, Nul DR, Serra JL, Thierer JM, Cross DB, Sindone AP, Singh BB, Boreux JL, Charlier FP, Dendale P, De Keulenaer G, Marchandise B, Marechal P, Marenne F, Mieghem WV, Van Dorpe AC, Vanhaecke J, Arnold JM, Dion D, Huynh T, Kouz SM, Lepage S, McKelvie RS, O'Meara E, Proulx G, Sauve C, Aschermann M, Brecka D, Filipovsky J, Groch L, Jerabek O, Jokl I, Linkova H, Motovska Z, Munz J, Penicka M, Rucka D, Mid JS, Spacek R, Spinar J, Stipal R, Vojacek J, Attali P, Bonneau A, Bousser JP, Dutoit L, Funck F, Galinier MP, Gibelin P, Hautefeuille BD, Hittinger L, Jobic Y, Jourdain P, Komajda M, Maupas E, Olive T, Philias A, Roul G, Rouleau F, Trochu JN, Boehm M, Bruch L, Drexler H, Engelhardt H, Erbs S, Foerster A, Franz N, Hambrecht R, Heuer H, Krueger U, Landmesser U, Leischik R, Mitrovic V, Moehlenkamp S, Monti J, Mueller-Ehmsen J, Oezcelik C, Philipp S, Pieske B, Roehnisch JU, Schunkert H, Schwinger R, Wachter R, Willenbrock R, Winkelmann BR, Winkler R, Wollert KC, Adamopoulos S, Kalikazaros I, Karavidas A, Karvounis H, Kremastinos D, Manolis AJ, Nanas I, Sotirellos K, Vasiliadis K, Zaboulis C, Lee S, Yu CM, Czibok C, Édes I, Forster T, Preda I, Simon K, Takacs J, Zámolyi K, Bhagavatula KS, Chockalingam K, Desai N, Iyengar SS, Jayadev SM, Mullasari AS, Sathe SP, Sinha N, Vadagenalli PS, Wander GS, McDonald KM, Nash P, Vaughan CJ, Agostoni P, Ambrosio GB, Bittolo Bon G, Boffa G, Cacciavillani L, Capucci A, Chiariello M, Cirrincione V, Gensini GF, Masini F, Modena MG, Monte I, Perrone Filardi P, Rosano GM, Senni M, Sinagra G, Tamburino C, Terrosu P, Villani GQ, Volterrani M, Chae SC, Ha CW, Ha JW, Shin JH, Bayram-Llamas E, Calvillo JC, Cruz-Diaz A, Delgado-Leal L, Estrada-Gomez MM, Kosturakis D, Petersen-Aranguren F, Velasco-Sanchez RG, Daniëls MC, Dirkali A, Dunselman PH, de Kluiver EP, Kragten JA, Lok DJ, Maas AH, Michels HR, Nicastia DM, Stoel I, de Swart JB, Thijssen HJ, Van Kempen LH, Voors AA, Willems FF, Dluzniewski M, Gaciong Z, Kawecka-Jaszcz K, Jozwa R, Korewicki J, Krzeminska-Pakula M, Kurowski M, Ogorek M, Pempera M, Rynkiewicz A, Ujda M, Wierzchowiecki M, Abreu Á, Andrade A, Carrageta M, Fonseca C, Franco F, Gil VM, Lousada N, Mendonca C, Moreira I, Padua FP, Providência L, Cardoso JC, Trabulo M, Aroutyunov GP, Gindin K, Karpov YB, Kostenko VA, Nikitin YP, Obraztsova GI, Shilkina NP, Shlyakhto EV, Skvortsov A, Ding ZP, Yeo DP, Ambrovicova V, Gaspar L, Goncalvesova E, Kycina P, Litvinova J, Mikes Z, Murin J, Poliacik P, Uhliar R, Lloyd EA, Marx D, Naidoo DP, Prozesky HW, Sliwa-Hahnle K, Theron H, Anguita M, De Teresa E, Galve E, Juanatey JR, Orbe PM, Vida M, Ahremark U, Andersson B, Axelsson U, Berglund S, Boman K, Dahlstrom U, Fu M, Holm Orndahl L, Johansson A, Lindgren M, Nemeczek C, Prantare H, Roussine V, Stehn G, Stenberg A, Swedberg K, Vasko P, Bazylevych A, Dyadyk OI, Dzyak GV, Girina OM, Ignatenko GA, Kononenko LG, Kubyshkin VF, Kuryata OV, Parkhomenko AN, Perepelytsya MV, Pertseva TO, Popik GS, Rishko MV, Sakharchuk II, Tseluyko VI, Tykhonova SA, Vizir V, Voronkov LG, Al Khaja N, Almahmeed WA, Bazargani N, Adgey AA, Al-Mohammad A, Banerjee P, Barlow M, Bridges AB, Brooks N, Connolly EC, Denvir MA, Egdell RM, Kardos A, Keeling PJ, Khokhar AA, McMurray JJ, Senior R, Williams SG, Anand IS, Anderson JL, Berk MR, Bertolet BD, Bisognano JD, Blonder RD, Breburda CS, Canaday DB, Capodilupo RC, Choiunard MD, Colucci WS, Dahiya RJ, Dunlap SH, Essandoh LK, Flores AR, Henderson DA, Herzog WR Jr, Katz RJ, Kosinski EJ, Labin IN, Lally FL, Lash JA, McGrew FA 3rd, Mohiuddin SM, Moraes D, Murali SC, Nallasivan M, Philbin E, Prabhu S, Primack D, Ramani R, Rawitscher D, Sangrigoli R, Schamalfuss CM, Stoletniy L, Strong MH, Thadani U, Treasure CB 2nd, Vicari RM, Vogel CD, Wlsh MN, Wencker D, Wilson SA, Winkel E, Wiseman AH, Zoiopoulos LY, Mancebo JR, Mendoza I, Waich ST.

Author information

  • 1INSERM, Centre d'Investigation Clinique 9501 and Unité 961, and the Department of Cardiology, Nancy University, Nancy, France. f.zannad@chu-nancy.fr

Abstract

BACKGROUND:

Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms.

METHODS:

In this randomized, double-blind trial, we randomly assigned 2737 patients with New York Heart Association class II heart failure and an ejection fraction of no more than 35% to receive eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.

RESULTS:

The trial was stopped prematurely, according to prespecified rules, after a median follow-up period of 21 months. The primary outcome occurred in 18.3% of patients in the eplerenone group as compared with 25.9% in the placebo group (hazard ratio, 0.63; 95% confidence interval [CI], 0.54 to 0.74; P<0.001). A total of 12.5% of patients receiving eplerenone and 15.5% of those receiving placebo died (hazard ratio, 0.76; 95% CI, 0.62 to 0.93; P=0.008); 10.8% and 13.5%, respectively, died of cardiovascular causes (hazard ratio, 0.76; 95% CI, 0.61 to 0.94; P=0.01). Hospitalizations for heart failure and for any cause were also reduced with eplerenone. A serum potassium level exceeding 5.5 mmol per liter occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001).

CONCLUSIONS:

Eplerenone, as compared with placebo, reduced both the risk of death and the risk of hospitalization among patients with systolic heart failure and mild symptoms. (Funded by Pfizer; ClinicalTrials.gov number, NCT00232180.).

Comment in

PMID:
21073363
[PubMed - indexed for MEDLINE]
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