"We have the opportunity and the responsibility to learn from these experiences about how to use aldosterone antagonists safely before we recommend expanding this to the population at risk," she said.
When asked by reporters whether the data support the use of spironolactone in mild heart failure, Dr. Zannad said that it’s possible to extrapolate the results to spironolactone, but that the findings are limited to eplerenone at a dose of 50 mg in patients with NYHA class II heart failure and an ejection fraction of no more than 35%.
One-half of patients in the trial had previously been hospitalized for heart failure and had a history of MI, two-thirds had hypertension, and one-third had diabetes and a QRS duration greater than 130 milliseconds. The mean ejection fraction was 26%, and one-quarter had left bundle branch block.
During a panel discussion of the study, Dr. Zannad said now that eplerenone has demonstrated efficacy in all symptomatic patients, the next step will be to evaluate the drug in asymptomatic patients and in those with preserved ejection fractions. He cited the ongoing TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial in 4,500 adults with heart failure and a left ventricular ejection fraction of at least 45%.
The EMPHASIS-HF results were simultaneously published in the New England Journal of Medicine (2010 Nov. 14; doi:10.1056/NEJMoa1009492).
EMPHASIS-HF was funded by Pfizer Inc. Dr. Zannad reported receiving grants from and consulting for Pfizer. Two coauthors are Pfizer employees, and several others reported Pfizer grants and consultancy.