EPHESUS Trial Eplerenone PostAMI Heart Failure Efficacy and

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 g g g 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): g Primary – 1) death from any cause and 2) death or hospitalization from CV causes www. Clinical trial results. org N Engl J Med 2003; 348: 1309 -21

EPHESUS Trial: Primary Endpoints All-cause Mortality CV Death or Hospitalization RR 0. 85 RR 0. 83 p=0. 008 p=0. 005 Eplerenone www. Clinical trial results. org Placebo Eplerenone Placebo N Engl J Med 2003; 348: 1309 -21

EPHESUS Trial: Secondary Endpoint CV Death RR 0. 87 p=0. 002 Eplerenone www. Clinical trial results. org Placebo N Engl J Med 2003; 348: 1309 -21

EPHESUS Trial: Serious Adverse Events Serious hyperkalemia Gynecomastia p=0. 70 p=0. 002 Eplerenone www. Clinical trial results. org Placebo Eplerenone Placebo N Engl J Med 2003; 348: 1309 -21