In a few weeks, on March 9, the main results of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study will be presented in San Francisco at the annual meeting of the American College of Cardiology. These results have been eagerly awaited since Merck’s brief announcement in December that the trial had not met its primary endpoint and that it would no longer pursue approval of Tredaptive, the combination of extended-release niacin and laropiprant, in the US. The trial was designed to assess whether adding the niacin/laropiprant combination to standard statin therapy in high risk individuals would further reduce vascular events.
Now, serving almost as a coming attraction for the main event at the ACC, an important substudy from HPS2-THRIVE has been published in the European Heart Journal. The paper discusses the trial design, the pre-specified muscle and liver outcomes, and the reasons for stopping treatment during the trial.