EPHESUS
Trial question
What is the role of eplerenone in patients with acute MI complicated by LV dysfunction and HF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 6632
6632 patients (1918 female, 4714 male).
Inclusion criteria: patients with acute MI complicated by LV dysfunction and HF.
Key exclusion criteria: use of potassium-sparing diuretics, a serum creatinine concentration > 2.5 mg/dL, and a serum potassium concentration > 5.0 mmol/L before randomization.
Interventions
N=3319 eplerenone (25 mg per day initially, titrated to a maximum of 50 mg per day).
N=3313 placebo (matching placebo).
Primary outcome
CV death or hospitalization for CV events
26.7%
30%
30.0 %
22.5 %
15.0 %
7.5 %
0.0 %
Eplerenone
Placebo
Significant
decrease ▼
NNT = 30
Significant decrease in CV death or hospitalization for CV events (26.7% vs. 30%; RR 0.87, 95% CI 0.79 to 0.95).
Secondary outcomes
Significant decrease in death from any cause or hospitalization (52% vs. 55%; RR 0.92, 95% CI 0.86 to 0.98).
Safety outcomes
Significant differences in serious hyperkalemia (5.5% vs. 3.9%, p = 0.002) and hypokalemia (8.4% vs. 13.1%, p < 0.001).
Conclusion
In patients with acute MI complicated by LV dysfunction and HF, eplerenone was superior to placebo with respect to CV death or hospitalization for CV events.
Reference
Pitt B, Remme W, Zannad F et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003 Apr 3;348(14):1309-21.
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