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European Journal of Heart Failure 2006 8(3):295-301; doi:10.1016/j.ejheart.2005.11.008
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© 2005 European Society of Cardiology

Evaluation of eplerenone in the subgroup of EPHESUS patients with baseline left ventricular ejection fraction ≤30%

Bertram Pitta,*, Mihai Gheorghiadeb, Faiez Zannadc, Jeffrey L. Andersond, Dirk J. van Veldhuisene, Alexander Parkhomenkof, Ramon Corbalang, Eric Q. Klugh, Robin Mukherjeei, Henry Solomoni and On behalf of the EPHESUS Investigators

a University of Michigan Medical Center, Alfred Taubman Health Care Center 1500 East Medical Center Drive, Ann Arbor, MI 48109, USA
b Northwestern University Feinberg School of Medicine Chicago, IL, USA
c Clinical Investigation Center INSERM-CHU de Nancy Hopital Jeanne d'Arc, Dommartin-les Toul, France
d LDS Hospital Salt Lake City, UT, USA
e University Hospital Groningen, Groningen The Netherlands
f Institute of Cardiology, Intensive Care Department Kyiv, Ukraine
g Department of Cardiovascular Diseases, Clinical Hospital of the Catholic University of Chile Santiago, Chile
h Sunninghill Hospital Sunninghill, South Africa
i Pfizer Inc New York, NY, USA

* Corresponding author. Tel.: +1 734 936 5260; fax: +1 734 936 5256. E-mail address: bpitt{at}med.umich.edu (B. Pitt)


   Abstract

Aims: Because of the prognostic importance of LV dysfunction following an AMI and the increasing use of electrical and/or mechanical interventions in patients with LV systolic dysfunction, this retrospective analysis of EPHESUS patients with LVEF ≤30% at baseline was conducted to determine the value of eplerenone in this setting.

Methods and Results: In EPHESUS, 6632 patients with LVEF ≤40% and clinical heart failure (HF) post-AMI who were receiving standard therapy were randomized to eplerenone 25 mg/day titrated to 50 mg/day or placebo for a mean follow-up of 16 months. Treatment with eplerenone in the subgroup of patients with LVEF ≤30% (N=2106) resulted in relative risk reductions of 21% versus placebo in both all-cause mortality (P=0.012) and cardiovascular (CV) mortality/CV hospitalization (P=0.001), and 23% for CV mortality (P=0.008). The relative risk of sudden cardiac death (SCD) was reduced 33% (P=0.01) and HF mortality/HF hospitalization was reduced 25% (P=0.005) with eplerenone compared with placebo. Within 30 days of randomization, eplerenone resulted in relative risk reductions of 43% for all-cause mortality (P=0.002), 29% for CV mortality/CV hospitalization (P=0.006), and 58% for SCD (P=0.008).

Conclusions: Treatment with eplerenone plus standard therapy in patients with post-AMI HF and LVEF ≤30% provided significant incremental benefits in reducing both early and late mortality and morbidity.

Key Words: Aldosterone • Heart failure • Left ventricular systolic dysfunction • Eplerenone • EPHESUS

Received July 19, 2005; Revised November 3, 2005; Accepted November 17, 2005


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