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Eplerenone Provides Cardioprotective Benefits in Patients with Heart Failure Complicated By Myocardial Infarction: Presented at ESH

By Jill Stein

PARIS, FRANCE -- June 17, 2004 -- The addition of the selective aldosterone blocker eplerenone (Inspra) to routine treatment for systolic left ventricular dysfunction and heart failure post-myocardial infarction significantly reduces morbidity and mortality in high-risk patients, say researchers.

According to data reported on June 16th at the 14th meeting of the European Society of Hypertension (ESH), the findings from the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and SUrvival (EPHESUS) study also show that the approach benefits patients with hypertension and other cardiovascular diseases. The results were presented by Faiez Zannad, MD, with the department of cardiovascular diseases at Inserm-CHU in Nancy, France.

The EPHESUS study involved 6642 patients, 3 to 14 days post acute MI, who were randomized to 4 weeks of treatment with eplerenone 25 mg/d or placebo, after which the doses of eplerenone were titrated to a target of 50 mg/d. Eplerenone or placebo was administered in addition to optimal medical therapy, which included angiotensin-converting-enzyme inhibitors and beta blockers.

All participants in the study had an acute MI, a left ventricular ejection fraction of 40 % or less, and pulmonary rales. The mean length of follow up was 16 months.

The study findings indicate that eplerenone plus conventional therapy was associated with a 15% relative risk reduction in total mortality (P =.008), a 17% relative risk reduction in cardiovascular mortality (P =.005), and a 13% relative risk reduction in cardiovascular mortality/cardiovascular hospitalization (P =.002) compared with patients treated with placebo on top of standard therapy.

There were also reductions in the rate of sudden death from cardiac causes (RR 0.79, P =.03).

After 1 week and 1 year, systolic blood pressure and diastolic blood pressure increased in both groups from baseline, although the increases were smaller in the eplerenone group. At one year, the increase was 8/4 versus 5/3 mmHg in the 2 groups, respectively (P < .01).

In patients with a history of hypertension (60% of patients enrolled in EPHESUS), the benefit was even larger. Treatment with eplerenone resulted in a 23% reduction in total mortality (P =.001), a 16% reduction in cardiovascular mortality and hospitalization (P =.002), a 26% reduction in sudden cardiac death (P =.021) and a 14% reduction in heart failure mortality/heart failure hospitalizations (P =.06) compared with placebo.

Eplerenone was well tolerated.

Dr. Zannad said that it is particularly important to note that the benefits of eplerenone were "over and above" the effects of other therapies known to improve the natural history of patients with systolic left ventricular dysfunction post-MI.

EPHESUS was conducted by more than 300 investigators in 37 countries.


[Study title: 8A.1 EPHESUS: Evidence for the Cardioprotective Effects of Selective Aldosterone Blockade)

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