The results of HPS2-THRIVE were “disappointing but clear,” said Jane Armitage, who presented the results this morning at the ACC in San Francisco.
HPS2-THRIVE randomized 25,673 high-risk patients who could tolerate niacin to either placebo or extended-release niacin plus laropiprant (Tredaptive, Merck), an anti-flushing agent, in addition to background therapy. The primary endpoint was the time to first major vascular event, defined as the composite of non-fatal MI or coronary death, any stroke or any arterial revascularization.
Major vascular events occurred in 13.2% of the niacin arm and 13.7% of the placebo arm (p=0.29), despite causing average reductions in LDL of 10 mg.dL and triglycerides of 33 mg/dL, in addition to a 6 mg/dL increase in HDL. Armitrage reported that based on data from previous trials and observational studies, “it was anticipated such lipid differences might translate into a 10-15% reduction in vascular events.”
HPS2-THRIVE study chairman, Rory Collins, responded to a question in the press conference: “To the question is niacin dead? Well, it’s not healthy!”