Merck today announced the company is taking steps to suspend the availability of TREDAPTIVE™ (extended-release niacin/laropiprant) tablets worldwide. TREDAPTIVE is not approved for use in the United States.
Merck 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 (Dec. 20, 2012 news release), 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 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.
In countries where the medicine is currently available, Merck has begun informing regulatory agencies of the company’s decision. Merck 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 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,” said Michael Rosenblatt, MD, Chief Medical Officer, Merck.
About the HPS2-THRIVE Study
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.
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. Patients in the study were followed for a median of 3.9 years. HPS2-THRIVE compared extended release niacin and laropiprant plus statin therapy versus statin therapy. It was not designed to assess directly the separate effects of either extended-release niacin or laropiprant.
In the study, adding the combination of extended-release niacin and laropiprant to statin therapy did not significantly further reduce the risk of the combination of coronary deaths, nonfatal heart attacks, strokes or revascularizations compared to statin therapy. In addition, 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.
Preliminary analyses suggest that the adverse events fall within the following broad categories: blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin. Additional analyses are ongoing to understand the adverse events within these categories.
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. Sales through the first three quarters of 2012 were approximately $13 million.
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