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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.

Full Text of this Article

Related Letters:

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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• Pitt, B., Pitt, G. S. (2007). Added Benefit of Mineralocorticoid Receptor Blockade in the Primary Prevention of Sudden Cardiac Death. Circulation 115: 2976-2982 [Full Text]  
• Ahmed, A., Zannad, F., Love, T. E., Tallaj, J., Gheorghiade, M., Ekundayo, O. J., Pitt, B. (2007). A propensity-matched study of the association of low serum potassium levels and mortality in chronic heart failure. Eur Heart J 28: 1334-1343 [Abstract] [Full Text]  
• Bomback, A. S., Klemmer, P. J. (2007). Association of low-grade urinary albumin excretion with left ventricular hypertrophy in the general population: a reply. Nephrol Dial Transplant 22: 1787-1788 [Full Text]  
• Grossmann, C., Krug, A. W., Freudinger, R., Mildenberger, S., Voelker, K., Gekle, M. (2007). Aldosterone-induced EGFR expression: interaction between the human mineralocorticoid receptor and the human EGFR promoter. Am. J. Physiol. Endocrinol. Metab. 292: E1790-E1800 [Abstract] [Full Text]  
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• Rosendorff, C., Black, H. R., Cannon, C. P., Gersh, B. J., Gore, J., Izzo, J. L. Jr, Kaplan, N. M., O'Connor, C. M., O'Gara, P. T., Oparil, S. (2007). Treatment of Hypertension in the Prevention and Management of Ischemic Heart Disease: A Scientific Statement From the American Heart Association Council for High Blood Pressure Research and the Councils on Clinical Cardiology and Epidemiology and Prevention. Circulation 115: 2761-2788 [Full Text]  
• Alexander, K. P., Newby, L. K., Armstrong, P. W., Cannon, C. P., Gibler, W. B., Rich, M. W., Van de Werf, F., White, H. D., Weaver, W. D., Naylor, M. D., Gore, J. M., Krumholz, H. M., Ohman, E. M. (2007). Acute Coronary Care in the Elderly, Part II: ST-Segment-Elevation Myocardial Infarction: A Scientific Statement for Healthcare Professionals From the American Heart Association Council on Clinical Cardiology: In Collaboration With the Society of Geriatric Cardiology. Circulation 115: 2570-2589 [Abstract] [Full Text]  
• Friedrich, E. B, Bohm, M. (2007). MANAGEMENT OF END STAGE HEART FAILURE. Heart 93: 626-631 [Full Text]  
• Assmus, B., Fischer-Rasokat, U., Honold, J., Seeger, F. H., Fichtlscherer, S., Tonn, T., Seifried, E., Schachinger, V., Dimmeler, S., Zeiher, A. M. (2007). Transcoronary Transplantation of Functionally Competent BMCs Is Associated With a Decrease in Natriuretic Peptide Serum Levels and Improved Survival of Patients With Chronic Postinfarction Heart Failure: Results of the TOPCARE-CHD Registry. Circ. Res. 100: 1234-1241 [Abstract] [Full Text]  
• Lindenfeld, J., Masoudi, F. A. (2007). Fluid Retention With Thiazolidinediones: Does the Mechanism Influence the Outcome?. J Am Coll Cardiol 49: 1705-1707 [Full Text]  
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• Brown, D. C., Szabo, S., Oikonomopoulos, T., Hoffmeister, H. M., Kashyap, A. S., Kashyap, S., Anand, K. P., Keeley, E. C., Hillis, L. D. (2007). Primary percutaneous coronary intervention.. NEJM 356: 1588-1589 [Full Text]