Merck tells physicians to stop prescribing Tredaptive

January 15, 2013

Merck is halting sales of its cholesterol drug-extended-release niacin/laropiprant (Tredaptive)-after preliminary data from a study showed that it did not achieve its primary end point of reduction of major vascular events and also raised safety concerns.

 

Merck is halting sales of its cholesterol drug-extended-release niacin/laropiprant (Tredaptive)-after preliminary data from a study showed that it did not achieve its primary end point of reduction of major vascular events and also raised safety concerns.

Tredaptive is not approved for use in the United States.

As previously reported by Merck, preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study did not achieve its primary end point of reduction of major vascular events, and there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received Tredaptive compared to statin therapy. The decision to suspend availability of the medicine is aligned with the recommendation of the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) based on the trial’s results.

Merck is recommending that physicians stop prescribing Tredaptive. Merck is also recommending that physicians review treatment plans for patients taking Tredaptive in a timely manner to discontinue Tredaptive and consider other changes in therapy to achieve their dyslipidemia management goals. In the meantime, Merck encourages patients with questions to speak with their healthcare provider, and to not discontinue therapy without first speaking with their physician.

“Patients currently taking Tredaptive are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure that physicians have appropriate information as we take steps to suspend the availability of Tredaptive,” Merck Chief Medical Officer Michael Rosenblatt, MD, said in a company release.