EPHESUS

Summary:

Evaluated eplerenone versus placebo in patients with acute myocardial infarctions, left ventricular dysfunction (EF < 40%) and heart failure symptoms OR left ventricular dysfunction and diabetes without heart failure symptoms. Eplerenone had a 16% relative risk reduction in cardiovascular death and hospitalizations for cardiovascular events. There was a 8% relative risk reduction in all-cause mortality and a 21% relative risk reduction of sudden death from cardiac causes. There was an increased risk of serious hyperkalemia.

Original Publication:

N Engl J Med. 2003 Apr 3;348(14):1309-21.

Trial Details:

Eponym: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study

Purpose: To evaluate the use of eplerenone (aldosterone antogonist) after acute myocardial infarctions with there is left ventricular systolic dysfunction (EF < 40%) and heart failure or diabetes.

Format: Double-blind, multicenter, randomized control trial

Treatment Group: Eplerenone

Control Group: Placebo

Number of Patients: 6,452

Inclusion Criteria:

  • Acute myocardial infarction
  • Left ventricular dysfunction with EF < 40%
  • Congestive heart failure symptoms, chest x-ray findings or an S3 heart sound
  • Diabetes mellitus type II with left ventricular dysfunction even if no heart failure symptoms present

Exclusion Criteria:

  • Use of potassium sparing diuretics (spironolactone, triamterene)
  • Creatnine > 2.5 mg/dL
  • Potassium level > 5.0 mmol/L

Follow-up: Mean 16 months

Primary Endpoint:

  • Time to death from any cause
  • Composite of time to death from cardiovascular cause and hospitalization for cardiovascular event

Secondary Endpoint:

  • Cardiovascular mortality
  • All-cause mortality
  • All-cause hospitalization

Related Links:

Review of Unstable Angina and Non-ST Elevevation Myocardial Infarction

Review of ST Elevation Myocardial Infarction

Review of Congestive Heart Failure