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:
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Acute myocardial infarction
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Left ventricular dysfunction with EF < 40%
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Congestive heart failure symptoms, chest x-ray findings or an S3 heart sound
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Diabetes mellitus type II with left ventricular dysfunction even if no heart failure symptoms present
Exclusion Criteria:
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Use of potassium sparing diuretics (spironolactone, triamterene)
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Creatnine > 2.5 mg/dL
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Potassium level > 5.0 mmol/L
Follow-up: Mean 16 months
Primary Endpoint:
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Time to death from any cause
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Composite of time to death from cardiovascular cause and hospitalization for cardiovascular event
Secondary Endpoint:
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Cardiovascular mortality
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All-cause mortality
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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