Preliminary data from the HPS2-THRIVE study revealed that reduction of major vascular events, the study’s primary endpoint, was not achieved in patients receiving nicotinic acid/laropiprant. In addition, a significant increase in the incidence of adverse effects was observed in patients given the combination. A review by the Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of treatment no longer outweigh the risks.
Tredaptive is indicated in dyslipidaemia, particularly combined mixed dyslipidaemia, and primary hypercholesterolaemia, in combination with statins when statins alone are inadequate or as monotherapy when statins are inappropriate or not tolerated.
Clinicians are advised to review treatment plans in patients currently receiving the drug in order to discontinue it.
Further information: Merck Sharp & Dohme Ltd