November 14th, 2010
Emphatic Support for Eplerenone in NYHA Class II Heart Failure
Larry Husten, PHD
Aldosterone antagonists have proven beneficial in heart failure patients with moderate-to-severe symptoms and in MI patients with LV dysfunction and heart failure. Now EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) has extended these benefits to patients with systolic HF and mild symptoms.
EMPHASIS HF randomized 2737 patients with NYHA class II HF and an ejection fraction not over 35% to receive eplerenone or placebo in addition to standard therapy. The trial, which was presented at the AHA meeting in Chicago and published simultaneously in the New England Journal of Medicine, was stopped early after 21 months. The rate of cardiovascular death or HF hospitalization was reduced from 25.9% in the placebo group to 18.3% in the eplerenone group (P<0.001). Total mortality was reduced from 15.5% to 12.5% (P<0.001). Hyperkalemia occurred significantly more often in the eplerenone group.
In an accompanying editorial, Paul Armstrong writes that the effect reported in EMPHASIS HF “seems surprisingly large for a trial of mildly symptomatic patients.” He points out that most of the trial participants were “heart disease veterans” at high risk and that few patients received implantable defibrillators or cardiac resynchronization therapy. Nevertheless, he states that with a number needed to treat of 19 to prevent one cardiovascular death or hospitalization and an NNT of 51 to prevent one death, the trial places “this therapy in the front rank of therapeutic choices.”
Fabulous for patients across the spectrum of CHF. Not surprising, but terrific to have the RCT data! This should immediately impact the routine care of CHF patients everywhere! What particularly struck me where the large absolute spreads in event rates (and therefore the very impressive NNT), particularly given the excellent background therapy of proven mortality and morbidity reducing pharmacotherapies. Kudo to the trialists for presevering with this difficult trial!