Tredaptive fails to meet primary endpoint in HPS2-THRIVE study
The HPS2-THRIVE study of extended-release niacin and laropiprant did not achieve its primary endpoint, according to a press release Merck issued today.
During a median follow-up of 3.9 years, extended-release niacin and laropiprant (Tredaptive) added to statin therapy did not significantly reduce the risk for coronary death, nonfatal MI, stroke or revascularization compared with statin alone. According to the release, there was a significant increase in the occurrence of some types of nonfatal but serious events among patients assigned combination therapy.
The independent study was conducted at Oxford University and funded by Merck. Researchers for HPS-2 THRIVE enrolled 25,673 patients considered to be at high risk for CV events. Of those enrolled, 14,741 were from Europe and 10,932 were from China.
The investigators are conducting additional analyses to further understand the results of HPS-2 THRIVE. Detailed study results are anticipated in the first quarter of 2013.
Merck and the independent investigators encouraged health care providers not to start new patients on Tredaptive. Merck is not seeking regulatory approval of the drug in the United States, according to the release. Tredaptive, also known as Cordaptive, has been approved in approximately 70 countries and is sold in 40 countries, according to the release.