EPHESUS

Trial Details:

Acronym: 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

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:

Pitt B, et al. N Engl J Med. 2003;doi:10.1056/NEJMoa030207.