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
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
EPHESUS Trial
N Engl J Med 2003;348:1309-21
Optimal medical therapy
(ACE inhibitors, angiotensin-receptor blockers, diuretics, and beta-blockers, coronary reperfusion therapy)
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)
All-cause Mortality
RR 0.85
p=0.008
EPHESUS Trial: Primary Endpoints
CV Death or Hospitalization
RR 0.83
p=0.005
Eplerenone
Placebo
N Engl J Med 2003;348:1309-21
Eplerenone
Placebo
CV Death
RR 0.87
p=0.002
EPHESUS Trial: Secondary Endpoint
N Engl J Med 2003;348:1309-21
Eplerenone
Placebo
Serious hyperkalemia
p=0.002
EPHESUS Trial: Serious Adverse Events
Gynecomastia
p=0.70
Eplerenone
Placebo
N Engl J Med 2003;348:1309-21
Eplerenone
Placebo