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Eplerenone Use Significantly Reduces All-Cause Mortality in Heart Failure Patients: Presented at HFSA

By Cameron Johnston

TORONTO, ON -- September 14, 2004 -- Patients with heart failure who are treated with the aldosterone-blocking agent eplerenone have significantly reduced all-cause mortality, cardiovascular mortality and cardiovascular hospitalizations compared with placebo.

The results of a multicenter trial were presented here September 13^th at the Heart Failure Society of America Annual Scientific Meeting, and also showed that the risk of death was 5-fold greater among those who were not hospitalized for heart failure.

The study was conducted in France, Britain and the United States by Faiez Zannad, MD, Centre d'Investigation Clinique, Institut de Santé et de la Recherche Médicale (INSERM) - Centre Hospitalier Universitaire de Nancy, Hôpital Jeanne d'Arc, Dommartin-les-Toul, France, and colleagues. They enrolled more than 6600 patients who were randomized to receive either eplerenone or placebo within 3 to 14 days of experiencing a myocardial infarction.

Patients, who had clinical evidence of heart failure with left ventricular ejection fraction of less than 40%, were divided into two groups: 3313 were treated with eplerenone 25 mg/day titrated up to 50 mg/day and the remainder were given placebo plus standard therapy. All were followed for up to 2.5 years (mean 16 months)

Dr. Zannad said that hospitalization for heart failure has a great impact on patient outcomes. As is frequently the case with heart failure, the study patients had numerous co-morbidities and the majority were taking concomitant medications. For example, at baseline, 749 subjects in the study group had diabetes, 1983 had hypertension and 1048 had a baseline ejection fraction of less than 30%. Mean age of the patients was 64 years at enrollment.

Virtually all subjects were already taking multiple medications: 87% were taking ACE inhibitors or angiotensin, 88% aspirin, 75% beta blockers, 60% diuretics and 47% statins. Approximately 45% had had a coronary artery bypass graft.

Overall, at the end of follow-up, the primary end point outcomes were as follows: all-cause mortality declined by 15%; cardiovascular mortality and hospitalizations were reduced by 13%. As for secondary end-points, sudden cardiac deaths were reduced by 21%; all cause mortalities/total hospitalizations were reduced by 8%. Hospital admissions due specifically to heart failure were reduced by 15%.

The study also revealed that the risk ratio (RR) for patients who were not hospitalized was 5.1 while the RR for those who were hospitalized but heart failure was not the primary diagnosis was 2.9. Those who were admitted to hospital and CV factors were not the primary cause had a RR of 2.3.

This study demonstrates that while eplerenone can significantly reduce all-cause mortality rates among patients with heart failure, it is also important to hospitalize these patients and ensure that their heart failure is the primary diagnosis at admission once they are taken to the hospital.


[Presentation title: "The Effect of Eplerenone on All-Cause Mortality and Heart Failure Hospitalization in the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS)." Poster 215]

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