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Eplerenone Post-AMI Heart Failure Efficacy and Survival Study

EPHESUS Trial. Eplerenone Post-AMI Heart Failure Efficacy and Survival Study. Presented at ACC 2003 Late Breaking Clinical Trials N Engl J Med 2003;348:1309-21. EPHESUS Trial. 6,632 patients with acute MI complicated by heart failure and systolic left ventricular dysfunction

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Eplerenone Post-AMI Heart Failure Efficacy and Survival Study

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  1. EPHESUS Trial Eplerenone Post-AMI Heart Failure Efficacy and Survival Study Presented at ACC 2003 Late Breaking Clinical Trials N Engl J Med 2003;348:1309-21

  2. EPHESUS Trial • 6,632 patients with acute MI complicated by heart failure and systolic left ventricular dysfunction • Acute MI in prior 3-14 days • Left ventricular dysfunction (EF <40%) • Heart failure (in non-diabetics but not required for diabetics) Optimal medical therapy (ACE inhibitors, angiotensin-receptor blockers, diuretics, and beta-blockers, coronary reperfusion therapy) Eplerenone (n = 3,313) Placebo (n = 3,319) • Endpoints (at mean of 16 month follow-up): • Primary – 1) death from any cause and 2) death or hospitalization from CV causes N Engl J Med 2003;348:1309-21

  3. EPHESUS Trial: Primary Endpoints All-cause Mortality RR 0.85 p=0.008 CV Death or Hospitalization RR 0.83 p=0.005 Eplerenone Eplerenone Placebo Placebo N Engl J Med 2003;348:1309-21

  4. EPHESUS Trial: Secondary Endpoint CV Death RR 0.87 p=0.002 Eplerenone Placebo N Engl J Med 2003;348:1309-21

  5. EPHESUS Trial: Serious Adverse Events Serious hyperkalemia p=0.002 Gynecomastia p=0.70 Eplerenone Eplerenone Placebo Placebo N Engl J Med 2003;348:1309-21

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