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Eplerenone Appears Safe and Effective for Diabetic Patients With Post-Acute Myocardial Infarction Heart Failure: Presented at ADA

By Bruce Sylvester

ORLANDO, FL -- June 7, 2004 -- Eplerenone appears to be a safe and effective treatment for diabetic patients with post-acute myocardial infarction (AMI) heart failure, researchers reported here on June 6th at the 64th annual meeting of the American Diabetes Association.

Results of a landmark study, the EPHESUS (EPlerenone's neuroHormonal Efficacy and SUrvival Study ) trial, showed the selective aldosterone blocker to improve all-cause mortality and sudden death in diabetic patients following infarction, said James O'Keefe, MD, Director of Preventive Cardiology, MidAmerica Heart Institute, Kansas City, Kansas.

A sub-analysis of the EPHESUS trial retrospectively examined data from a subset of 1483 diabetic patients with left ventricular systolic dysfunction and signs of heart failure, post-AMI. Investigators determined diabetic status of participants based on medical histories at screening and conducted analysis time-to-first-occurrence of an event.

Patients in EPHESUS were randomized to receive either eplerenone 25 mg/day titrated to 50 mg 4 times/day or placebo. They used the primary end points of total mortality, cardiovascular mortality/hospitalization time. Secondary end points were cardiovascular mortality and total mortality/total hospitalization time.

In assessing the safety and efficacy of eplerenone in this diabetic subpopulation, the researchers utilized a Cox proportional hazards regression model stratified by region, using treatment, subgroup, and treatment-by-subgroup interaction as key factors. In addition, they utilized the Wald test to determine risk ratios.

Results showed that diabetic patients (with post-myocardial infarction and heart failure) who received eplerenone had a 15% reduction in risk of mortality when compared with the group who received placebo (P =.131). Other end points showed similar results. The researchers noted a 17% reduction in cardiovascular mortality and cardiovascular hospitalization (P =.031). The risk of cardiovascular mortality was reduced by 17% and sudden cardiac death by 11% (P =.128; P =.533, respectively).

Eplerenone was recently approved by the Food and Drug Administration, and released in the United States market in February 2004.

"This was a large study that showed impressive results in this particular subpopulation of diabetic patients. And I predict that eplerenone will be by far and away the most important diuretic we use not only in diabetics but in cardiovascular patients in general," Dr. O'Keefe concluded.

The research was supported by Pfizer.


[Presentation title: "Eplerenone Is Safe and Effective in Diabetic Patients with Post-Acute Myocardial Infarction Heart Failure: Results from EPHESUS." Abstract #491-P]

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