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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

-HF trial was a double-blind, placebo-controlled, parallel group trial comparing the effect of eplerenone plus standard heart failure therapy versus placebo plus standard heart failure therapy on mortality and morbidity outcomes in patients with mild chronic systolic heart failure (NYHA functional Class II) and left ventricular systolic dysfunction.  The composite primary endpoints were the first occurrence of either cardiovascular (CV) death or heart failure (HF) hospitalization. The EMPHASIS-HF trial was to enroll approximately 3,100 patients and was to continue until a total of 813 adjudicated primary endpoint events were reported.  

Inspra does not have a licence for use in the patient population studied in the EMPAHSIS-HF trial in any individual market.

Professor Faiez Zannad, Inserm and University of Nancy, France, co-Chair of the Executive Steering Committee, commented; "It is not common for clinical studies to conclude early for reasons of efficacy.  The EMPHASIS-HF trial had an estimated end date around October 2011 so to have met the pre-defined efficacy endpoints early is certainly a positive outcome."

Pfizer has informed the relevant Regulatory Agencies, Ethics Committees/Independent Review Boards and Investigators as appropriate in countries where the trial was being conducted, and continues to work with the DSMC, Executive Steering Committee and all study investigators globally.  In addition, Pfizer is working to ensure all patients are informed via their clinicians and an amendment to the protocol will be requested in order to allow all consenting patients to start treatment with eplerenone in an open label extension of the study, after completing a close-out visit ending the double-blind placebo-controlled phase.

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