Use of Inspra in heart failure extended

7 June 2012

Inspra (eplerenone) has been approved for use with standard therapy to reduce the risk of cardiovascular morbidity and mortality in adults with chronic heart failure (NYHA class II) and left ventricular ejection fraction (LVEF) 30% or less.

Left ventricular dysfunction (LVD) reduces cardiac output and increases the strain on the heart, causing increased morbidity and mortality | SCIENCE PHOTO LIBRARY

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).

View Inspra drug record

Further information: Pfizer Ltd