Adding INSPRA® (eplerenone) to Standard Therapy Significantly Reduces the Risk of CV Mortality and Morbidity in Patients With Chronic Heart Failure With Mild Symptoms, Study ...
CHICAGO, Nov. 14, 2010 /PRNewswire-FirstCall/ -- 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%; p<0.0001).
Heart failure can lead to a reduction in the quality of life, frequent admissions to hospital and a greatly shortened life expectancy, despite the availability of several effective treatments(2). Dr. Faiez Zannad, Professor of Therapeutics and cardiologist at the CHU (University Hospital) of the Henri Poincare University of Nancy, France and co-chair of the EMPHASIS-HF Steering Committee said: "It is encouraging to see a clinical trial deliver results that are sufficiently strong to meet strict pre-defined stopping criteria. Patients such as those enrolled in EMPHASIS-HF typically have a poor prognosis and today's results should therefo