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News in brief

Merk (NJ, USA), known as MSD outside of the USA and Canada, has recently published an online press release announcing that they are taking steps to suspend the worldwide availability of Tredaptive. Tredaptive is an extended-release niacin/laropiprant tablet (ERN/LRPT) that has been reported to increase HDL cholesterol and apoA1, as well as reducing LDL cholesterol and triglycerides in patients receiving statin therapy. The announcement came following preliminary data from the HPS2-THRIVE study and consultation with regulatory authorities. Tredaptive, which is not available in the USA, failed to meet its primary goal of reducing major vascular events in the study; in addition, several serious nonfatal side effects were significantly increased. Tredaptive, also known as Pelzont, Trevaclyn and Cordaptive has been approved in approximately 70 countries and is sold in 40 of them. The decision to suspend the availability of Tredaptive agrees with a recommendation from the EMA’s Pharmacovigilance Risk Assessment Committee. The lipid-altering properties of niacin have been well documented, although a number of unpleasant side effects have also been recorded. Laropripant has been shown to reduce flusing, the most common niacin side effect, and improve niacin tolerability. The study, upon which the decision to suspend Tredaptive was based, aimed to assess whether the addition of ERN/LRPT improved outcomes in patients taking statins. The HPS2-THRIVE study, which involved over 25,000 patients considered to be at high risk of cardiovascular events from the UK, Scandinavia and China, followed patients for a median of 3.9 years comparing groups of patients receiving statin therapy plus ERN/LRPT with statin therapy plus a placebo. Carried out by Oxford University and funded by Merk, the study reported that adding ERN/LRPT to statin therapy did not significantly reduce the combined coronary deaths, nonfatal heart attacks, strokes or revascularizations compared with statin therapy alone.