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PURPOSE: The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trial of patients at high risk of vascular disease found that adding extended-release niacin-laropiprant to intensive statin-based LDL-lowering therapy had no benefit on cardiovascular outcomes. However, the trial also identified previously unrecognized serious adverse effects (including new-onset diabetes, bleeding, and infection). Our objective was to explore the safety profile of niacin-laropiprant and examine whether any patients were at lower (or higher) risk of its adverse effects. METHODS: HPS2-THRIVE was a randomized, double-blind trial of niacin-laropiprant (2000/40 mg/d) versus placebo among 25,673 patients at high risk of vascular disease. Information on all serious adverse events was collected during a median of 3.9 years of study treatment. Effects of niacin-laropiprant on new-onset diabetes, disturbances of diabetes control, bleeding, infection, and gastrointestinal upset were estimated by (1) time after randomization, (2) severity, (3) baseline characteristics, (4) baseline risk of the adverse event of interest, and (5) risk of major vascular event. FINDINGS: The hazard ratio (HR) for new-onset diabetes with niacin/laropiprant was 1.32 (95% CI, 1.16-1.51; P 

Original publication

DOI

10.1016/j.clinthera.2019.06.012

Type

Journal article

Journal

Clin Ther

Publication Date

09/2019

Volume

41

Pages

1767 - 1777

Keywords

adverse effects, bleeding, cardiovascular disease, infection, niacin, Cardiovascular Diseases, Delayed-Action Preparations, Diabetes Mellitus, Double-Blind Method, Drug Therapy, Combination, Dyslipidemias, Female, Hemorrhage, Humans, Hypolipidemic Agents, Incidence, Indoles, Infections, Male, Niacin