“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%.
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.
The EMPHASIS-HF results were also published in the New England Journal of Medicine (2010 Nov. 14; doi:10.1056/NEJMoa1009492).
The trial was stopped early when an interim analysis showed an “overwhelming benefit” with eplerenone, said Dr. Faiez Zannad.