Merck, known as MSd outside the U.S. and Canada, is taking steps to suspend the availability of nicotinic acid/laropiprant (Tredaptive) modified-release tablets worldwide.
The company is taking these steps based on the current understanding of the preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, and in consultation with regulatory authorities. As previously reported by Merck, HPS2-THRIVE did not achieve its primary endpoint of reduction of major vascular events, and there was a statistically significant increase in the incidence of some types of nonfatal serious adverse events in the group that received Tredaptive compared with 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 based on the trial’s results.
In countries where the medicine is currently available, Whitehouse Station, N.J.-based Merck has begun informing regulatory agencies of the company’s decision. Merck said it is working with these agencies to develop communications for healthcare providers and to suspend the availability of Tredaptive, with the timing to be based on individual country regulations and processes.
Merck is "recommending that physicians stop prescribing Tredaptive. Merck also is 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,” said Michael Rosenblatt, MD, chief medical officer of Merck.
HPS2-THRIVE was independently conducted by the Clinical Trial Service Unit at Oxford University and funded by Merck. With the agreement of the independent research team at Oxford University, Merck is sharing results from the study with regulatory agencies. The investigators are conducting additional analyses to further understand the results. They anticipate reporting the detailed study results in the first quarter of 2013.
Tredaptive has been approved in approximately 70 countries, including in Europe, and is sold in approximately 40 countries. Tredaptive is also sold under the brand names Pelzont in Italy and Trevaclyn in Italy and Portugal and Cordaptive in other markets around the world.