HPS2-THRIVE Post-Mortem: Lessons Learned For CV Drug Developers

While risks clearly outweigh benefits for niacin as an add-on therapy in the more than 25,000-patient HPS2-THRIVE study, investigators argue that the door is still open for other HDL-raising drugs. One panelist at the ACC meeting where results were presented calls for smaller, more targeted trials in the future.

SAN FRANCISCO – Full results from the HPS2-THRIVE study of Merck & Co. Inc.’s Tredaptive have heightened scrutiny about outcomes studies for cardiovascular drugs and may lead to changes in the way these studies are designed.

The more than 25,000-patient trial failed to show a significant improvement in cardiovascular outcomes with treatment with Merck’s combination of extended-release niacin and laropiprant, an anti-flushing compound intended to mitigate a common side effect of niacin. Announcing top-line results in December, Merck had said that it was dropping U.S

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