Physicians sometimes prescribe niacin for statin(ex: Lipitor, crestor, zocor, etc)-treated patients to raise HDL cholesterol levels or to manipulate lipid subfractions detected by more elaborate lipid testing. However, the clinical effect of this practice is unclear. In the National Institute of Health sponsored study, 3414 patients with established cardiovascular disease were randomized to receive simvastatin plus either extended-release niacin or placebo. Enrollment criteria included HDL cholesterol levels <40 mg/dL for men and <50 mg/dL for women, and triglyceride levels between 150 and 400 mg/dL.
Compared with placebo, niacin therapy induced significant changes in LDL cholesterol, HDL cholesterol, and triglyceride levels. Nevertheless, the trial was stopped after average follow-up of 3 years when no hint of cardiovascular benefits and a trend toward more strokes with niacin were reported. The primary outcome (a composite of adverse coronary events, strokes, and revascularization) occurred in 16% of patients in each group; the incidence of stroke was 1.7% with niacin and 1.1% with placebo (P=0.09).
Comment: These results — are straightforward: Extended-release niacin doesn't benefit patients with known cardiovascular disease who achieve low LDL cholesterol levels with statin monotherapy (the average LDL cholesterol level in this study's statin-plus-placebo group was about 70 mg/dL). Note that this study was purely a secondary prevention trial; we also have no evidence that niacin improves outcomes in contemporary primary prevention. One can also question from this study whether lowering LDL, increasing HDL, lowering cholesterol and triglycerides all reduce cardiovascular disease.
This is why we cannot place so much importance on just one study. They need to be repeated and the variables need to be reduced so that whatever is being tested is what affects the results. However sometimes there are variables that cannot be controlled which results in uncertainties. No one is infurring that niacin supplements should be discontinued. The need for additional studies is evident at this point in time.