This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. For questions and comments, please e-mail: firstname.lastname@example.org.
A new study confirms the lack of effectiveness of niacin for reducing major vascular events, essentially putting the nail in the coffin for use of this once-popular drug. Researchers in the United Kingdom randomized more than 25,000 high-risk patients (those with evidence of vascular disease) to 2 g of extended-release niacin along with 40 mg of laropiprant (given with niacin to reduce flushing) or placebo. All patients were already being treated with a statin. The primary outcome was first major vascular event (nonfatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization). After a median follow-up of nearly 4 years, niacin was effective at lowering low-density lipoprotein (LDL) cholesterol by an average of 10 mg/dL and raising high-density lipoprotein (HDL) cholesterol by an average of 6 mg/dL. However, niacin had no effect on major vascular events (patients with an event: 13.2% niacin vs 13.7% placebo, rate ratio 0.96; 95% confidence interval, 0.90-1.03; P = 0.29). Niacin-laropiprant was associated with worsening of diabetes control and an increased incidence of diabetes as well as other serious adverse events, including gastrointestinal, musculoskeletal, skin rashes, increased rate of infections, and bleeding. The authors conclude that adding niacin-laropiprant to a statin did not reduce the risk of major vascular events but did increase serious adverse events in high-risk vascular patients (N Engl J Med 2014;371:203-212). The authors suggest that these findings are consistent with trials of niacin alone and are likely to be generalizable to all high-dose niacin formulations. An accompanying editorial extends niacin’s complete failure in all efforts to raise HDL cholesterol, pointing out the failure of other drugs that raise HDL to reduce the risk of vascular events — findings that “undermine the hypothesis that HDL cholesterol is a causal risk factor” for cardiovascular disease (N Engl J Med 2014;371:271-273). Niacin-laropiprant is a combination that Merck has tried to get approved in this country for years. It was approved in Europe in 2008. However, based on this study and others, Merck has withdrawn the product from the market worldwide.
Source: By William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco.