Wink Jennifer, Giacoppe George, King James
Department of Medicine, Madigan Army Medical Center, Tacoma, WA 98431, USA.
Am Heart J. 2002 Mar;143(3):514-8. doi: 10.1067/mhj.2002.120158.
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.
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.
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.
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.
低密度脂蛋白（HDLC）水平较低是已被证实的冠状动脉疾病风险因素。烟酸可提高HDLC水平，但因其副作用情况而较少使用。烟酸的副作用与剂量相关。本研究检验了这样一个假设，即极低剂量的烟酸与长期他汀类药物治疗相结合，将通过显著提高HDLC水平来改善血脂谱，且副作用比传统剂量的烟酸更少。
50例接受稳定他汀类药物治疗3个月的患者被随机分为两组，一组接受安慰剂，另一组接受每日口服两次、每次50mg的烟酸，为期3个月。排除糖尿病患者和现吸烟者。每位患者在治疗前后均完成一份关于当前医疗问题、药物治疗和生活方式的问卷。询问患者在药物试验期间出现的任何可能的副作用。主要终点是HDLC水平的变化和患者报告的副作用。
39例患者完成了研究。他汀类药物治疗中添加极低剂量的烟酸可提高平均HDLC水平，烟酸组提高了2.1mg/dL（平均标准误差为0.767），而安慰剂组降低了0.56mg/dL（平均标准误差为0.816，方差分析P = 0.0246）。5例接受烟酸治疗的患者出现脸红，而接受安慰剂治疗的患者有2例。未观察到重大副作用。没有患者因副作用而停止研究药物治疗。
在他汀类药物治疗中添加极低剂量的烟酸可显著提高HDLC胆固醇水平，同时避免了与传统剂量烟酸治疗相关的副作用。
