Li Xiang-ping, Duan Jun, Zhao Shui-ping, Tan Ming-yue, Xu Zhu-mei, Zhang Da-qing
Department of Cardiology, Second Xiangya Hospital of Central-South University, Changsha, China.
Zhonghua Yi Xue Za Zhi. 2006 Sep 12;86(34):2399-403.
To evaluate the efficacy and safety of extended-release niacin (niacin ER) either alone or in combination with atorvastatin for the lipid profile modification in the patients with coronary heart disease (CHD) and its equivalents.
One hundred and ten patients with CHD and its equivalents with serum total cholesterol (TC) > or = 3.5 mmol/L were randomly assigned into three treatment groups: (1) atorvastatin group (n = 38), receiving atorvastatin 10 mg/d for 8 weeks; (2) niacin ER group (n = 38), given niacin ER 500 mg/d for 4 weeks and then 1000 mg/d for 4 weeks; (3) combination treatment group (n = 34), treated with atorvastatin (10 mg/d) plus niacin ER, with the dose initiating from 500 mg/d, and increasing to 1000 mg/d after 4 weeks, for 8 weeks. The serums lipid profiles and adverse effects were assessed in all the patients before treatment, and 4 and 8 weeks after treatment.
(1) After 8 weeks of treatment, the serum level of triglyceride (TG) and high-density lipoprotein cholesterol (HDL-C) were reduced by 30% and 16% respectively in the niacin ER group compared with the baseline values (both P < 0.05). After 8 weeks, the TC, low-density lipoprotein cholesterol (LDL-C), and TG in the atorvastatin group decreased by 19%, 26%, and 17% respectively compared with the baseline values (all P < 0.05). Combination treatment decreased the TC, LDL-C, and TG levels by 28%, 38%, and 39% respectively, and increased the HDL-C level by 23% (all P < 0.05). The improvement in TC and LDL-C achieved by combination treatment was superior to treatment of atorvastatin alone and treatment of niacin ER alone (all P < 0.05). (2) The rate of achieving the LDL-C goal of The National Cholesterol Education Program (NCEP) in Adult Treatment Panel III (ATP III) in the combination therapy group was 73.5%, significantly higher than those of the atorvastatin and niacin groups (47.7% and 42.1% respectively, both P < 0.05). (3) Adverse effect, such as flushing (15.8%) and gastrointestinal symptoms (23.7%) were found in the niacin ER group, however, no more adverse effects were found in the combination therapy group. There were no serious adverse events in all groups.
Niacin ER has a favorable effect in modulating the blood lipid profile, especially in reducing TG and elevating HDL-C. Combined statin with niacin may produce a more global and effective improvement in lipid blood levels than monotherapy and is generally safe and well tolerable.
评估缓释烟酸（niacin ER）单独使用或与阿托伐他汀联合使用对冠心病（CHD）及其等效病症患者血脂谱的改善效果及安全性。
110例血清总胆固醇（TC）≥3.5 mmol/L的CHD及其等效病症患者被随机分为三组：（1）阿托伐他汀组（n = 38），接受阿托伐他汀10 mg/d治疗8周；（2）缓释烟酸组（n = 38），先给予缓释烟酸500 mg/d治疗4周，然后1000 mg/d治疗4周；（3）联合治疗组（n = 34），接受阿托伐他汀（10 mg/d）加缓释烟酸治疗，起始剂量为500 mg/d，4周后增至1000 mg/d，共治疗8周。在所有患者治疗前、治疗4周和8周后评估血脂谱及不良反应。
（1）治疗8周后，缓释烟酸组血清甘油三酯（TG）水平较基线值降低30%，高密度脂蛋白胆固醇（HDL-C）水平降低16%（均P < 0.05）。阿托伐他汀组治疗8周后，TC、低密度脂蛋白胆固醇（LDL-C）和TG水平较基线值分别降低19%、26%和17%（均P < 0.05）。联合治疗使TC、LDL-C和TG水平分别降低28%、38%和39%，HDL-C水平升高23%（均P < 0.05）。联合治疗在改善TC和LDL-C方面优于阿托伐他汀单药治疗和缓释烟酸单药治疗（均P < 0.05）。（2）联合治疗组达到美国国家胆固醇教育计划（NCEP）成人治疗专家组第三次报告（ATP III）中LDL-C目标值的比例为73.5%，显著高于阿托伐他汀组和缓释烟酸组（分别为47.7%和42.1%，均P < 0.05）。（3）缓释烟酸组出现如潮红（15.8%）和胃肠道症状（23.7%）等不良反应，然而联合治疗组未发现更多不良反应。所有组均未出现严重不良事件。
缓释烟酸在调节血脂谱方面具有良好效果，尤其在降低TG和升高HDL-C方面。他汀类药物与烟酸联合使用可能比单药治疗在改善血脂水平上更全面有效，且总体安全，耐受性良好。
Zotero 插件