Effect of very-low–dose niacin on high-density lipoprotein in patients undergoing long-term statin therapy *

Abstract Background A low level of high-density lipoprotein (HDLC) is a proven risk factor for coronary artery disease. Niacin raises HDLC levels, but it is infrequently used because of its side effect profile. Niacin's side effects are dose related. This study tests the hypothesis that very low–dose niacin, in conjunction with long-term statin therapy, will improve the lipid profile by significantly raising the level of HDLC, with fewer side effects than traditional doses of niacin. Methods Fifty patients undergoing stable statin therapy for 3 months were blindly randomized to receive either placebo or niacin 50 mg administered by mouth 2 times daily for 3 months. Patients with diabetes and active smokers were excluded. Each patient completed a questionnaire regarding current medical problems, medications, and lifestyle before and after the therapy. Patients were questioned about any possible side effects that occurred during the medication trial. The primary end points were change in HDLC level and patient-reported side effects. Results Thirty-nine patients completed the study. Very low–dose niacin added to statin therapy increased the mean HDLC, 2.1 mg/dL in niacin group (standard error of the mean, 0.767) versus −0.56 mg/dL for placebo group (standard error of the mean-.816, P =.0246 by analysis of variance). Five patients receiving niacin, versus 2 patients receiving placebo, had episodes of flushing. No major side effects were noted. No patients stopped the study medication as a result of side effects. Conclusions The addition of very low–dose niacin to statin therapy increased HDLC cholesterol significantly, while avoiding the side effects that are associated with traditional doses of niacin therapy. (Am Heart J 2002;143:514-8.)