Serious Side Effects Seen With Failed Merck & Co., Inc. Niacin Drug
Published: Mar 11, 2013
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).
As previously disclosed, there were statistically significant increases in non-fatal serious adverse events observed in patients taking TREDAPTIVE plus statin therapy compared to patients taking placebo plus statin therapy. These events included: diabetic complications, new onset diabetes, infection, gastrointestinal, musculoskeletal, bleeding (including gastrointestinal and intracranial) and skin. There was also a small excess in heart failure.
“Merck has a long and proud history of supporting major outcomes studies to investigate challenging scientific questions and advance our collective understanding of cardiovascular medicine,” said Michael Mendelsohn, M.D., senior vice president, cardiovascular medicine, Merck Research Laboratories. “The results of HPS2-THRIVE add substantially to the body of scientific knowledge in this important therapeutic area.”
As noted, HPS2-THRIVE (Clinicaltrials.gov identifier: NCT 00461630) 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. HPS2-THRIVE compared extended-release niacin and laropiprant (a flushing pathway inhibitor) plus statin therapy versus statin therapy. It was not designed to assess directly the separate effects of either extended-release niacin or laropiprant.
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