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Previous Volume 348:1309-1321 April 3, 2003 Number 14 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Jessup, M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article Related Article by O'Brien, W. F. PubMed Citation

ABSTRACT

Background Aldosterone blockade reduces mortality and morbidity among patients with severe heart failure. We conducted a double-blind, placebo-controlled study evaluating the effect of eplerenone, a selective aldosterone blocker, on morbidity and mortality among patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.

Methods Patients were randomly assigned to eplerenone (25 mg per day initially, titrated to a maximum of 50 mg per day; 3313 patients) or placebo (3319 patients) in addition to optimal medical therapy. The study continued until 1012 deaths occurred. The primary end points were death from any cause and death from cardiovascular causes or hospitalization for heart failure, acute myocardial infarction, stroke, or ventricular arrhythmia.

Results During a mean follow-up of 16 months, there were 478 deaths in the eplerenone group and 554 deaths in the placebo group (relative risk, 0.85; 95 percent confidence interval, 0.75 to 0.96; P=0.008). Of these deaths, 407 in the eplerenone group and 483 in the placebo group were attributed to cardiovascular causes (relative risk, 0.83; 95 percent confidence interval, 0.72 to 0.94; P=0.005). The rate of the other primary end point, death from cardiovascular causes or hospitalization for cardiovascular events, was reduced by eplerenone (relative risk, 0.87; 95 percent confidence interval, 0.79 to 0.95; P=0.002), as was the secondary end point of death from any cause or any hospitalization (relative risk, 0.92; 95 percent confidence interval, 0.86 to 0.98; P=0.02). There was also a reduction in the rate of sudden death from cardiac causes (relative risk, 0.79; 95 percent confidence interval, 0.64 to 0.97; P=0.03). The rate of serious hyperkalemia was 5.5 percent in the eplerenone group and 3.9 percent in the placebo group (P=0.002), whereas the rate of hypokalemia was 8.4 percent in the eplerenone group and 13.1 percent in the placebo group (P<0.001).

Conclusions The addition of eplerenone to optimal medical therapy reduces morbidity and mortality among patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.

Source Information

From the University of Michigan, Ann Arbor (B.P.); STICARES, Cardiovascular Research Foundation, Rotterdam, the Netherlands (W.R.); the Centre d'Investigation Clinique de Nancy, Nancy, France (F.Z.); the University of Minnesota, Minneapolis (J.N.); the Fundación Rusculleda, Cordoba, Argentina (F.M.); and Pharmacia, Skokie, Ill. (B.R., R.B., S.H., J.K., M.G.).

Address reprint requests to Dr. Pitt at the Department of Internal Medicine, Division of Cardiology, University of Michigan Medical Center, 3910 Taubman, 1500 E. Medical Center Dr., Ann Arbor, MI 48109-0366, or at bpitt{at}umich.edu.

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Eplerenone in Patients with Left Ventricular Dysfunction
Aggarwal A., Coca S. G., Buller G. K., Blaustein D. A., Schwenk M. H., Pitt B., the EPHESUS Investigators
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N Engl J Med 2003; 349:88-89, Jul 3, 2003. Correspondence

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