The aldosterone antagonist is already indicated for use in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical evidence of heart failure after recent MI.
EMPHASIS-HF trial results
The new indication was approved following a pivotal study in 2737 patients in 29 countries worldwide, comparing eplerenone (up to 50mg daily) plus standard optimal therapy to placebo plus standard optimal therapy in high-risk patients with NYHA class II heart failure and LVEF 35% or less. Results showed a 37% relative risk reduction with eplerenone in the rate of cardiovascular death or first hospitalisation for heart failure (p<0.001).
Eplerenone also reduced the secondary endpoints of hospitalisation for heart failure (–42%; p<0.001), all-cause mortality (–24%; p=0.008), cardiovascular mortality (–24%; p=0.01) and all-cause hospitalisation (–23%, p<0.001).
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Further information: Pfizer Ltd