Key result
Eplerenone reduced the risk of cardiovascular mortality or hospitalization by 17% (P=0.031) in diabetic patients with left ventricular systolic dysfunction and heart failure after myocardial infarction.
Why the study?
Does eplerenone reduce the composite of CV mortality or CV hospitalization in diabetic patients with LVSD and signs of CHF following AMI?
RCT (n=1,483)
Yes
Does eplerenone reduce the composite of CV mortality or CV hospitalization in diabetic patients with LVSD and signs of CHF following AMI?
Eplerenone significantly reduces cardiovascular mortality and hospitalization in diabetic patients with heart failure and left ventricular systolic dysfunction following an acute myocardial infarction.
Supports eplerenone in diabetic post-MI HF with LVSD; hypothesis-generating and should not yet change practice.
BACKGROUND: The Epleronone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) trial demonstrated that selective aldosterone blockade with eplerenone significantly reduced total mortality by 15%, combined cardiovascular (CV) mortality/CV hospitalization by 13%, CV mortality by 17% and sudden cardiac death by 21%, vs. placebo when added to standard care in patients with left ventricular systolic dysfunction (LVSD) and signs of congestive heart failure (CHF) following acute myocardial infarction (AMI). We retrospectively evaluated the effect of eplerenone vs. placebo in a subset of 1483 diabetic patients with LVSD and signs of CHF following AMI. METHODS: Diabetic status was determined from medical histories at screening. Analyses were based on time to first occurrence of an event. Results were based on a Cox's proportional hazards regression model stratified by region with treatment, subgroup and treatment-by-subgroup interaction as factors. The 95% confidence intervals for the risk ratios were based on the Wald's test. RESULTS: Treatment with eplerenone in diabetic patients with CHF following AMI reduced the risk of the primary endpoint, a composite of CV mortality or CV hospitalization, by 17% (p = 0.031). The absolute risk reduction of the primary endpoint was greater in the diabetic cohort (5.1%) than in the non-diabetic cohort (3%). Hyperkalaemia occurred more often with eplerenone than with placebo (5.6 vs. 3%, p = 0.015). Among the diabetic cohorts, the prespecified endpoint of 'any CV disorder' occurred in 28% of the eplerenone group and 35% of the placebo group (p = 0.007). CONCLUSION: Eplerenone treatment may reduce adverse CV events in diabetic patients with LVSD and signs of CHF following AMI.
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O’Keefe et al. (2007) conducted an RCT in Diabetic patients with left ventricular systolic dysfunction and signs of congestive heart failure following acute myocardial infarction (n=1,483). Eplerenone vs. Placebo was evaluated on Composite of CV mortality or CV hospitalization (RR 0.83, p=0.031). Eplerenone reduced the risk of cardiovascular mortality or hospitalization by 17% (P=0.031) in diabetic patients with left ventricular systolic dysfunction and heart failure after myocardial infarction.
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