Kaur Kirandeep, Rai Jaswant, Sharma Geeta, Bal Baljinder Singh
Departments of Pharmacology and Medicine, Government Medical College, Amritsar (Punjab), India.
Curr Ther Res Clin Exp. 2004 Nov;65(6):455-69. doi: 10.1016/j.curtheres.2005.01.002.
Abstract.
Patients with dyslipidemia often require the use of >1 lipid-altering agent to achieve the target levels recommended by the National Cholesterol Education Program Adult Treatment Panel III.
The aim of this study was to compare the effects of simvastatin and niacin alone and combined on the lipid profile and lipoprotein (a) (Lp[a]) level in an Indian population with dyslipidemia.
This 12-week, open-label, nonrandomized study was conducted at the Departments of Pharmacology and Medicine, Government Medical College, Amritsar (Punjab), India. Patients aged 30 to 70 years with dyslipidemia were eligible. Patients were assigned to 1 of 3 treatment groups. Group 1 received simvastatin 20 mg/d for 12 weeks. Group 2 received niacin at doses of 375 mg/d for 1 week, 500 mg/d for 1 week, and 500 mg BID for 10 weeks. Group 3 received simvastatin 10 mg/d plus niacin (375 mg for 1 week and 500 mg for 11 weeks). The lipid profile (low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol [TC], and triglycerides [TG]) and Lp(a) were measured before the start of therapy and at 6 and 12 weeks of treatment. Percentage changes from baseline were calculated. Adverse effects (AEs) were recorded at weeks 6 and 12 and through spontaneous reporting.
Ninety patients were enrolled (50 men, 40 women; 30 patients per treatment group). In group 1, the mean (SD) percentage decrease in LDL-C level at 12 weeks was 42.79% (16.29%) (P < 0.05), but no significant change was seen in group 2 or 3. The mean (SD) percentage increases in HDL-C level were 18.43% (13.28%) and 20.82% (17.57%) in groups 2 and 3, respectively (both, P < 0.05), but no significant change was seen in group 1. TC levels decreased by a mean (SD) of 32.97% (13.66%) in group 1 (P < 0.05), but no significant change was seen in group 2 or 3. TG and Lp(a) levels did not change significantly in any of the 3 treatment groups. Flushing, myalgia, and dyspepsia were the most common AEs in patients receiving niacin.
In this study in Indian patients with dyslipidemia, simvastatin-niacin combination therapy was associated with greater changes in lipid profile compared with either agent used alone. Niacin was also associated with greater changes in Lp(a) levels. AEs were less prevalent with combination therapy than with niacin alone.
摘要。
血脂异常患者通常需要使用一种以上的调脂药物，以达到美国国家胆固醇教育计划成人治疗专家组第三次报告所推荐的目标水平。
本研究旨在比较辛伐他汀和烟酸单药治疗及联合治疗对印度血脂异常人群血脂谱和脂蛋白(a) [Lp(a)]水平的影响。
本项为期12周的开放标签、非随机研究在印度阿姆利则（旁遮普邦）政府医学院药理学系和医学系进行。年龄在30至70岁的血脂异常患者符合入选条件。患者被分配到3个治疗组中的1组。第1组接受辛伐他汀20mg/d，共12周。第2组接受烟酸治疗，剂量为第1周375mg/d，第2周500mg/d，后10周500mg，每日2次。第3组接受辛伐他汀10mg/d加烟酸（第1周375mg，后11周500mg）。在治疗开始前以及治疗6周和12周时测量血脂谱（低密度脂蛋白胆固醇[LDL-C]、高密度脂蛋白胆固醇[HDL-C]、总胆固醇[TC]和甘油三酯[TG]）和Lp(a)。计算相对于基线的百分比变化。在第6周和第12周记录不良反应（AE），并通过自发报告收集。
90例患者入组（50例男性，40例女性；每个治疗组30例患者）。在第1组中，12周时LDL-C水平的平均（标准差）百分比下降为42.79%（16.29%）（P<0.05），但在第2组或第3组中未观察到显著变化。第2组和第3组HDL-C水平的平均（标准差）百分比升高分别为18.43%（13.28%）和20.82%（17.57%）（均P<0.05），但在第1组中未观察到显著变化。第1组TC水平平均（标准差）下降32.97%（13.66%）（P<0.05），但在第2组或第3组中未观察到显著变化。3个治疗组中的任何一组TG和Lp(a)水平均未发生显著变化。潮红、肌痛和消化不良是接受烟酸治疗患者中最常见的AE。
在这项针对印度血脂异常患者的研究中，与单独使用任一药物相比，辛伐他汀 - 烟酸联合治疗与血脂谱的更大变化相关。烟酸也与Lp(a)水平的更大变化相关。联合治疗的AE发生率低于单独使用烟酸。
