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EMPHASIS-HF: Eplerenone reduced death, hospitalization by 37% in systolic HF
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American Heart Association Scientific Sessions 2010
CHICAGO — Eplerenone was associated with a 37% reduction in the risk of death or hospitalization among patients with systolic HF, according to data from the EMPHASIS-HF trial.
Currently, aldosterone antagonists, including eplerenone, are only recommended in patients with moderate to severe HF and reduced heart function or among patients with HF who have had a recent MI.
Patients from 272 sites in 29 countries were randomly assigned 25 to 50 mg eplerenone (n=1,364; 21 patients were lost to follow-up or did not receive the study drug) or placebo (1,373; 19 patients were lost to follow-up or did not receive the study drug). The median follow-up was 21 months. The primary endpoint was CV death or hospitalization for HF.
Eplerenone was associated with a significant decrease in CV death or hospitalization for HF (HR=0.63; 95% CI, 0.54-0.74) and a 24% reduction in mortality from any cause (HR=0.76; 95% CI, 0.62-0.93). In addition, eplerenone reduced the rate of hospitalization for any cause by 23% (HR=0.77; 95% CI, 0.67-0.88) and the rate of HF hospitalization by 42% (HR=0.58; 95% CI, 0.47-0.70).
“The conclusions are straightforward: In patients with systolic HF and mild symptoms, the addition of eplerenone to recommended medical therapy was well tolerated, improved survival and prevented hospitalization,” Faiez Zannad, MD, PhD, professor of therapeutics at the University of Nancy in France, said during a press conference. “Of course we need to take this into context of the RALES AND EPHESUS trials and this, again, shows a very important external validity and consistency with the earlier trials, and provides compelling evidence to change medical practice.”
Zannad reports receiving grants and contracts from Pfizer, and has also consulted for Pfizer. – by Stacey Fisher
For more information:
- Zannad F. LBCT I, Abstract 23221. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.
As we move forward to the vision of patient-centered medicine, it requires us to understand the mechanism of both benefit and toxicity in order to achieve the best possible outcomes for our individual patients. This is an exciting day in deed where we can talk about a newer patient population for this drug, [but] we still have a lot of work ahead of us.
- Mariell L. Jessup, MD,
Professor of
Medicine, University of Pennsylvania, Philadelphia
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