Pfizer halts heart failure trial early because Inspra reaches endpoint

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Pfizer plans to halt recruitment to the EMPHASIS-HF trial early on the recommendations of the trial's independent Executive Steering Committee. The recommendations follow a second interim analysis by the Data Safety Monitoring Committee of the EMPHASIS-HF trial confirming the study has reached its primary efficacy endpoint early according to the protocol pre-defined stopping rules, the company reported.

Based upon the interim analyses by the independent data safety monitoring committee, the New York City-based company said eplerenone (Inspra) was generally “well tolerated” during the EMPHASIS-HF trial, reporting adverse events of hyperkalemia (elevated potassium) (8 percent of the eplerenone group versus 3 percent in the placebo group) and renal impairment (4 percent in the eplerenone group versus 2 percent in the placebo group).

The EMPHASIS-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.