Niacin, a B vitamin that our bodies use to convert carbohydrates into energy, has been used to increase high-density lipoprotein (HDL), also known as “good” cholesterol, for upward of 50 years. Northwestern Medicine researchers are now advising doctors to stop prescribing niacin for cholesterol therapy after revealing it serves no benefit in reducing heart attack or stroke risk, can cause dangerous side effects, and may increase a patient’s risk of death.

"There might be one excess death for every 200 people we put on niacin," Dr. Donald Lloyd-Jones, preventive cardiologist and chair of preventive medicine at Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, said in a statement. "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.”

Lloyd-Jones and his colleagues followed adults between 50 and 80 years old affected by cardiovascular disease. Participants were prescribed a cholesterol therapy that included extended-release niacin and laropiprant, a drug that reduces face flushing caused by high doses of niacin. They were also treated with a statin medication, which is prescribed to lower cholesterol levels. Over the course of four years, the research team compared the effectiveness of the niacin, laropiprant, statin regimen against a placebo.

By the end of the study, researchers noted a higher incidence of heart attacks and strokes among participants in the niacin group compared to those taking the placebo. Cardiovascular patients taking niacin were also at an increased risk of death from all causes and suffered serious side effects due to the medication, including liver problems, excess infections, excess bleeding, gout, loss of control of blood sugar for diabetics, and the development of diabetes.

"The recent niacin clinical trials offer important new evidence that raising 'good' cholesterol (HDL) levels on top of statin therapy does not have the positive outcome that had been hoped for," said Dr. Neil Stone, the Robert Bonow MD Professor in Cardiology at Feinberg and a cardiologist at Northwestern Memorial Hospital. "Lowering 'bad' cholesterol (LDL) with an optimal intensity of tolerated statins and adherence to healthy lifestyle changes remains the most effective approach to prevent strokes and heart attacks for patients at risk of cardiovascular disease."

Lloyd-Jones still recognized niacin as a suitable medication for increasing “good” (HDL) cholesterol levels. However, findings from the study showed no proof that niacin could lower a patient’s risk of coronary heart disease or cardiovascular disease by raising HDL. He suggests niacin only be prescribed to patients who cannot take statins or other evidence-based options and are at an increased risk of suffering a heart attack or stroke.

Source: Stone N, Lloyd-Jones D, et al. Effects of Extended-Release Niacin with Laropiprant in High-Risk Patients. New England Journal of Medicine. 2014.