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Title: Adding Eplerenone Benefits Myocardial Infarction Patients with Left Ventricular Dysfunction

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NEJM 2003;348:1309-1321.
04/03/2003 11:20:51 AM
By Elda Hauschildt

Adding eplerenone to optimal medical therapy reduces mortality in acute myocardial infarction (ACI) patients who also have left ventricular dysfunction and heart failure. Aldosterone blockade reduces mortality and morbidity in patients with severe heart failure, say researchers. This double-blind, international, multi-centre study evaluated the effects of one selective aldosterone blocker, eplerenone in ACI patients with left ventricular dysfunction and heart failure. The study was led by Dr. Bertram Pitt of the University of Michigan in Ann Arbor, United States. Mean dose of 43 milligrams per day was added from 3 to 14 days post-ACI, report researchers. Patients had additional reductions in overall mortality and the rate of death from cardiovascular causes. They also had fewer hospitalisations for cardiovascular events and reduced rates of death from any cause or any hospitalisation. Optimal medical therapy was defined as an angiotensin- converting enzyme (ACE) inhibitor or angiotensin-receptor blocker, a beta-blocker, aspirin, a lipid-lowering agent and coronary reperfusion therapy. A total of 3,313 patients were randomised to eplerenone while 3,319 received placebo, both in addition to optimal medical therapy. Eplerenone was titrated to a maximum of 50 mg per day. The study continued until 1,012 deaths occurred. There were 478 deaths in the eplerenone group and 554 deaths in the placebo group in mean follow-up of 16 months. Relative risk for patients receiving eplerenone was 0.85. Cardiovascular causes were responsible for 407 deaths in the eplerenone group and 483 in the placebo group, for a relative risk of 0.83. The rate for the other primary endpoint, death or hospitalisation for cardiovascular causes/events, was reduced by adding eplerenone to optimal therapy. Relative risk was 0.87. The rate for the secondary endpoint of death from any cause or any hospitalisation was also reduced in the eplerenone group, with a relative risk of 0.92. As well, there was a reduction in the rate of sudden death from cardiac causes (relative risk, 0.79). "With an estimated number needed to treat of 50 to save one life in one year and an estimated number needed to treat of 33 to prevent one death from cardiovascular causes of one hospitalisation for a cardiovascular event in one year, the addition of eplerenone to optimal medical therapy contributes to the continued improvement in survival and hospitalisation rates," the investigators concluded.

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