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Pfizer Announces EMPHASIS-HF Trial to Halt Recruitment due to Significant Benefit Observed in Patients Treated With Inspra® (Eplerenone)
Date:5/27/2010

p>About the EMPHASIS-HF trial

EMPHASIS HF (A6141079) is a phase IIIB, multinational (270 centers in approximately 30 countries), randomized, doubleblind placebocontrolled, parallelgroup trial.  It is conducted in a NHYA II chronic systolic heart failure population, which is a distinct population from the EPHESUS study population (patients with left ventricular dysfunction (LVEF less than or equal to 40 %) and clinical evidence of heart failure after recent myocardial infarction).

The primary objective of this trial is to evaluate the efficacy and safety of eplerenone plus standard heart failure (HF) therapy versus placebo plus standard HF therapy on the cumulative incidence of cardiovascular (CV) mortality and HF hospitalization (a composite primary endpoint).

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.

About Inspra®

Inspra® (eplerenone) is a steroid nucleus-based mineralcorticoid receptor (MR) antagonist with a higher degree of selectivity than spironolactone.  Eplerenone acts as a competitive and selective aldosterone blocker (SAB) at the mineralocorticoid receptor sites in various tissues throughout the body.

Inspra® Summary of Product Characteristics

UK prescribing information is available at:

SOURCE Pfizer Inc.
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