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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

NEW YORK, May 27 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE: PFE) announced that it plans 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.

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The interim analysis showed that patients treated with INSPRA® (eplerenone), in addition to current standard of care, experienced a significant reduction in risk of cardiovascular (CV) death or heart failure (HF) hospitalization compared with those on the placebo arm of the trial where patients received standard of care in addition to a matching placebo.  

Based upon the interim analyses by the independent data safety monitoring committee, eplerenone, generally, was well tolerated during the EMPHASIS-HF trial.  Adverse events reported included hyperkalemia (elevated potassium) (8 per cent of the eplerenone group vs 3% in the placebo group; p < 0.001) and renal impairment (4 per cent in the eplerenone group vs 2% in the placebo group; p < 0.05).  These adverse events are common with mineralcorticoid receptor antagonist agents.

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SOURCE Pfizer Inc.
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