Final Results of HPS2-THRIVE: No Benefit of Niacin in High-Risk Statin Treated Patients at Goal

The results of the HPS2-THRIVE study were released in the New England Journal of Medicine on July 17, 2014. Also, appearing in the same edition was a special correspondence from the AIM HIGH investigators concerning further analysis of adverse events, and an editorial addressing both of these publications.

In the HPS2-THRIVE report, the addition of niacin-laropiprant to high risk statin treated patients at LDL-C goal (mean LDL-C 64mg/dl), did not significantly reduce the risk of major vascular events (rate ratio, 0.96; 95% CI, 0.90 to 1.03; P = 0.29) despite a reduction of LDL-C of 10mg/dl and an increase in HDL-C of 6mg/dl. However, there was a significant increase in the risk of serious adverse events including diabetes mellitus (both DM control and new-onset DM), and associated events involving the gastrointestinal system, musculoskeletal system, and skin. Unexpectantly, there was an increased incidence of infection and bleeding complications.

It is unknown what effect the addition of laropiprant versus niacin alone had on the incidence of adverse events. However results from AIM-HIGH, and HPS2-THRIVE, demonstrate that the risks from routine clinical administration of niacin in optimally statin treated patients outweigh the medical benefit.

Therefore, the NLA recommends that clinicians curtail the use of niacin in patients who are optimally treated with statins. Although not specifically tested in other high risk populations, niacin may be warranted for use in patients whose clinical profile demonstrate the need for intensive lipid management, such as patients with Familial Hypercholesterolemia, severe hypertriglyceridemia, mixed dyslipidemia, statin intolerance, or those on maximally tolerated statin doses and not at goal. Furthermore, this clinical decision should be made by specialized clinicians with expertise in managing patients with severe dyslipidemias.