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July 30, 2014
New Study, Commentary: Should Niacin Be Used
to Lower Cholesterol? 

Chicago—Niacin has been used for half a century as a standard cholesterol therapy, but a new article and accompanying editorial raise questions about whether vitamin B3 should still be prescribed to most patients because of the potential for increased risk of death without significant benefit.

In an editorial in the New England Journal of Medicine, cardiologist Donald Lloyd-Jones, MD, of Northwestern University recommends against niacin’s use to lower cholesterol except in very specific cases. He was writing in response to a new study, also published in NEJM, which looked at statin-using adults, aged 50 to 80, with cardiovascular disease who took extended-release niacin and laropiprant to reduce facial flushing caused by high doses of niacin.

The study by the HPS2-THRIVE Collaborative Group found that niacin did not reduce heart attacks and stroke rates compared with a placebo. It also found an association between niacin and an increased trend toward death from all causes as well as significant increases in serious side effects.

For the study, researchers randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily. The first major vascular event—nonfatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization—was considered the primary outcome.

Results indicated that, with a median follow-up period of 3.9 years, study participants who were assigned to extended-release niacin–laropiprant had an LDL cholesterol level that was an average of 10 mg per deciliter lower and an HDL cholesterol level an average of 6 mg per deciliter higher than the placebo group. At the same time, the niacin–laropiprant group had no significant reduction in major vascular events compared to the placebo group—13.2% vs.13.7%, respectively.

More disturbing, according to the authors, was that niacin–laropiprant was associated with an increased incidence of serious disturbances in diabetes control, an increased incidence of diabetes diagnoses as well as increases in serious adverse events associated with the gastrointestinal system, the musculoskeletal system, the skin, and even infection and bleeding.

“There might be one excess death for every 200 people we put on niacin,” suggested Lloyd-Jones, who added, “With that kind of signal, this is an unacceptable therapy for the vast majority of patients.”

“For the reduction of heart disease and stroke risk, statins remain the most important drug-based strategy by far because of their demonstrated benefit and their good safety profile,” he said, emphasizing that niacin should be reserved only for patients who can’t take statins but are at very high risk for a heart attack and stroke.




U.S. Pharmacist Social Connect