Eplerenone Post-Ami Heart Failure Efficacy And Survival Study

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


Acronym

EPHESUS stands for Eplerenone Post-AMI Heart Failure Efficacy and Survival Trial.

Background

Eplerenone is an aldosterone antagonist that blocks the mineralocorticoid receptor. In contrast to spironolactone, it does not block the glucocorticoid, progesterone, or androgen receptors and for that reason it may may be associated with fewer side effects than spironolactone. Pre clinical studies have demonstrated that aldosterone antagonism may improve ventricular remodeling and collagen formation among patients who sustain LV dysfunction following an MI.

The EPHESUS study builds upon the RALES study (Randomized Aldactone Evaluation Study) which demonstrated that aldosterone inhibition with the older agent spironolactone reduced mortality when added to an ACE inhibitor among patients with severe congestive heart failure.

Results

End point

Eplerenone, No. (%)

Placebo, No. (%)

Relative risk (95% CI)

p

Mortality* 478 (14.4) 554 (16.7) 0.85
(0.75-0.96)
0.008
Cardiovascular mortality 407 (12.3) 483 (14.6) 0.83
(0.72-0.94)
0.005
CV mortality or hospitalization for CV events* 885 (26.7) 993 (30.0) 0.87
(0.79-0.95)
0.002

*Primary end points

Number Needed to Treat (NNT) = 50 patients to save one life, and 33 to prevent one cardiovascular death or rehospitalization.

Summary

Among MI patients with LV dysfunction, the administration of eplerenone (Inspra®, Pharmacia) in addition to evidence based therapy is associated with a 15% reduction in all cause mortality. In addition, cardiovascular death, and CV death and hospitalization were also significantly reduced.

References