November 17, 2010 – Chronic heart failure patients treated with eplerenone (Inspra) experienced a significant reduction in risk of cardiovascular death or heart failure hospitalizations. The data comes from the EMPHASIS-HF trial, which compared Pfizer’s drug to placebo and standard therapy in patients with mild symptoms.
Results were presented at the American Heart Association’s Scientific Sessions and published online in the New England Journal of Medicine.
The trial demonstrated a 37 percent relative risk reduction for the eplerenone group for death from cardiovascular causes or heart failure hospitalization. Additionally, there were significant reductions in all-cause mortality, cardiovascular mortality, all-cause hospitalization and heart failure hospitalization.
"It is encouraging to see a clinical trial deliver results that are sufficiently strong to meet strict pre-defined stopping criteria,” said Faiez Zannad, M.D., professor of therapeutics and cardiologist at the University Hospital of the Henri Poincare University of Nancy, France and co-chair of the EMPHASIS-HF steering committee. “Patients such as those enrolled in EMPHASIS-HF typically have a poor prognosis and today's results should therefore provide real encouragement for doctors and patients alike."
No new safety information emerged as a result of this study. As expected, there was a higher incidence of hyperkalemia (elevated potassium) among patients assigned to eplerenone compared to placebo. However, hypokalemia (low potassium) was lower in the eplerenone group.
Eplerenone (Inspra) is a steroid nucleus-based mineralcorticoid receptor (MR) antagonist with a higher degree of selectivity than spironolactone.
For more information: www.pfizer.com