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Adding INSPRA® (eplerenone) to Standard Therapy Significantly Reduces the Risk of CV Mortality and Morbidity in Patients With Chronic Heart Failure With Mild Symptoms, Study Shows
Date:11/14/2010

ased on the EPHESUS study population.

The primary objective of this trial is to evaluate the efficacy and safety of eplerenone plus standard heart failure (HF) therapy - including an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blockers (ARB), plus a beta–blocker – versus placebo plus standard HF therapy on the cumulative incidence of cardiovascular (CV) mortality and HF hospitalization (a composite primary endpoint).  The mean follow-up time was 21.1 months.

Patients were to be randomized (1:1) to receive eplerenone 25 mg once daily (OD) or matching placebo.  At four weeks, the dose of study drug could be increased to 50 mg OD (two 25mg tablets of eplerenone or two matching placebo tablets once daily) based on serum potassium level.  The trial was designed to enroll 3100 patients and to continue until a total of 813 adjudicated primary endpoint events were reported.

In May 2010, Pfizer announced that it planned to halt recruitment to the EMPHASIS-HF trial early on the recommendations of the trial's independent Executive Steering Committee (ESC).  The recommendations follow a second interim analysis by the independent Data Safety Monitoring Committee (DSMC) of the EMPHASIS-HF trial confirming the study has reached its primary efficacy endpoint early according to the protocol pre-defined stopping rules.

The study was funded by Pfizer.

About INSPRA®

INSPRA® (eplerenone) is a steroid nucleus-based mineralcorticoid receptor (MR) antagonist with a higher degree of selectivity than spironolactone.  Eplerenone is thought to be a more selective blocker at the mineralcorticoid receptor since there is evidence that some of the effects result from a blockade of cortisol stimulation of the MR-receptor.

Important Prescribing Information

In the United States, Inspra® (eplerenone) is indicated to improve survival of st
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SOURCE Pfizer Inc.
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