Merck (NYSE:MRK), known outside the United States and Canada as MSD, today announced that 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 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.
HPS2-THRIVE was independently conducted by the Clinical Trial Service Unit at Oxford University and funded by Merck. The study enrolled 25,673 patients considered to be at high risk for cardiovascular events. Of those enrolled, 14,741 were from Europe (the United Kingdom and Scandinavia) and 10,932 were from China. Patients in the study were followed for a median of 3.9 years. HPS2-THRIVE compared extended -release niacin and laropiprant plus statin therapy versus statin therapy. It was not designed to assess directly the separate effects of either extended-release niacin or laropiprant.