Physicians' Academy for Cardiovascular Education

HPS2-THRIVE: no benefit of niacin therapy, signs of increased adverse events

News - Jan. 7, 2013

The HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, the largest-ever study of niacin, did not meet its primary endpoint.

The study compared extended-release niacin and laropiprant, an anti-flushing agent, plus statin therapy versus statin therapy alone in 25,673 patients at high risk for cardiovascular events.

After a median follow-up of 3.9 years, the combination of niacin and laropiprant did not significantly further reduce the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations compared to statin therapy. Furthermore, 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.

HPS2-THRIVE was designed to answer criticism from the FDA and other experts about the lack of any evidence demonstrating clinical benefit.

The European Medicines Agency is reviewing the safety and efficacy of extended-release niacin/laropiprant. While the review is ongoing, no new patients should start treatment with the drug. The Pharmacovigilance Risk Assessment Committee  of the EMA will assess the data and make a recommendation to the Committee on Medicinal Products for Human Use, which is expected in January.


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