- Question
- Does adding eplerenone, a selective aldosterone blocker, to optimal medical therapy reduce morbidity and mortality in patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure?
- Design
- Randomized, double-blind, placebo-controlled trial that continued until 1012 deaths had occurred. Mean follow-up was 16 months.
- Population
- Patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure who were receiving optimal medical therapy.
- Intervention
- Eplerenone 25 mg daily initially, titrated to a maximum of 50 mg daily (3319 patients), added to optimal medical therapy.
- Control
- Placebo (3313 patients), added to optimal medical therapy.
- Primary outcome
- Two primary endpoints: death from any cause, and the composite of death from cardiovascular causes or hospitalization for heart failure, acute myocardial infarction, stroke, or ventricular arrhythmia.
- Results
- There were 478 deaths with eplerenone and 554 with placebo (relative risk 0.85; 95% CI 0.75 to 0.96; P=0.008). The composite of cardiovascular death or hospitalization for cardiovascular events was also reduced (relative risk 0.87; 95% CI 0.79 to 0.95; P=0.002), as was sudden cardiac death (relative risk 0.79; 95% CI 0.64 to 0.97; P=0.03).
- Safety
- Serious hyperkalemia was more frequent with eplerenone (5.5 percent vs 3.9 percent; P=0.002), whereas hypokalemia was less frequent (8.4 percent vs 13.1 percent; P<0.001).
- Conclusion
- Adding eplerenone to optimal medical therapy reduces morbidity and mortality in patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.
- Why it matters
- It extended the benefit of aldosterone blockade, previously shown in severe heart failure, to the post-infarction setting with ventricular dysfunction, and established mineralocorticoid receptor antagonists as part of the treatment of these patients, with potassium monitoring.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026