MSD 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 MSD, 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™ (nicotinic acid/laropiprant, MSD) 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 based on the trial’s results.
In countries where Tredaptive is currently available, MSD has begun informing regulatory agencies of the company’s decision. MSD is working with these agencies to develop communications for health care providers and to suspend the availability of Tredaptive, with the timing to be based on individual country regulations and processes.
MSD is recommending that physicians stop prescribing Tredaptive. MSD 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, MSD encourages patients with questions to speak with their health care 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 Dr Michael Rosenblatt, Chief Medical Officer, MSD.
