Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (
vents) study of TREDAPTIVE
(extended-release niacin/laropiprant) during a late-breaking clinical trials session at the American College of Cardiology 62
Annual Scientific Sessions (abstract 300-14). HPS2-THRIVE was independently conducted by the Clinical Trial Service Unit at Oxford University, the regulatory sponsor of the trial, and funded by Merck.
Merck previously announced that the study did not meet its primary endpoint (
December 20, 2012 news release
). Adding TREDAPTIVE to statin therapy did not significantly further reduce the risk of major vascular events compared to statin therapy in patients at high risk of cardiovascular events. Additionally, there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received TREDAPTIVE. Merck announced in January that it was taking steps to suspend the availability of TREDAPTIVE in countries where the medicine has been approved (
January 11, 2013 news release
). TREDAPTIVE is not approved in the United States.
The results of HPS2-THRIVE in 25,673 patients were presented by Professor Jane Armitage, FFPH, FRCP, professor of clinical trials and epidemiology, Oxford University and the primary investigator for the HPS2-THRIVE study. In the trial, the composite primary endpoint of major vascular events (coronary death, non-fatal heart attack, stroke or any arterial revascularization) occurred in 13.2 percent of the patients taking TREDAPTIVE plus statin therapy (n=1,696) compared to 13.7 percent of the patients taking statin therapy alone (n=1,758) after a median 3.9 years of follow-up. This corresponded to a risk ratio of 0.96 (95 percent CI: 0.90-1.03; p=0.29).