Pfizer halts cardiovascular drug Inspra trial recruitment on positive results

US global drugs behemoth Pfizer says that it plans to halt recruitment to the EMPHASIS-HF trial, assessing Inspra (eplerenone), early on the recommendations of the trial's independent Executive Steering Committee (ESC). This follow a second interim analysis by the independent Data Safety Monitoring Committee (DSMC) of the study confirming that it has reached its primary efficacy endpoint early according to the protocol pre-defined stopping rules.

The interim analysis showed that patients treated with Inspra, 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 on the interim analyses by the independent DSMC, eplerenone, generally, was well tolerated during the EMPHASIS-HF trial. Adverse events reported included hyperkalemia (elevated potassium) (8% of the eplerenone group versus 3% in the placebo group; p