Pfizer Inc. (NYSE: PFE) today announced results from the EMPHASIS-HF trial(1) showing a statistically significant reduction in risk of cardiovascular (CV) death or heart failure (HF) hospitalization for patients with chronic heart failure with mild symptoms treated with Inspra® (eplerenone) versus those given placebo in addition to standard HF therapy.
The results were presented to physicians attending the American Heart Association Scientific Sessions in Chicago and were simultaneously published online in the New England Journal of Medicine.
The EMPHASIS-HF trial demonstrated a statistically significant 37% relative risk reduction for the eplerenone group (p<0.0001) compared to placebo in the primary composite endpoint of death from CV causes or HF hospitalization. There were also statistically significant reductions in other secondary endpoints of all-cause mortality (24%; p=0.008), CV mortality (24%; p=0.012), all-cause hospitalization (23%, p<0.0001) and HF hospitalization (42%; p5.5mmol/L.) among patients assigned to eplerenone compared to placebo (11.8% vs 7.2%, respectively; p<0.001). In contrast, the incidence of hypokalemia (low potassium, defined as serum potassium level <3.5mmol/L.) was lower in the eplerenone group compared to placebo (7.5% vs 11.0%, respectively; p=0.002).
In May 2010, recruitment to the EMPHASIS-HF trial was halted early after the second pre-specified interim analysis showed that the study's pre-defined stopping rules had been met and a significant difference (two-sided P<0.001 in favor of eplerenone) in the primary endpoint was evident.
Source : Pfizer Inc.