Tredaptive (Merck Inc) fails in HPS2-THRIVE trial

The HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive(extended-release niacin/laropiprant) did not meet its primary endpoint. Merck Inc., and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to work with regulators to provide updated information to health care providers. Based on the current understanding of these new data and until further analyses can be completed, Merck is recommending that providers not start new patients on Tredaptive. Merck does not plan to seek regulatory approval for the medicine in the United States.

The study enrolled 25,673 patients considered to be at high risk for cardiovascular events.In the study, adding the combination of extended-release niacin and laropiprant to statin therapy did not significantly further reduce the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations compared to statin therapy. In addition, there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received extended-release niacin/laropiprant.