Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
J Cardiovasc Pharmacol. 2012 May;59(5):479-84. doi: 10.1097/FJC.0b013e31824ba699.
3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitory activity of atorvastatin lasts upto 20-30 hours. This study aimed at comparing the maintenance of National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII) goal by the alternate-day therapy to daily treatment. This randomized, open-label trial included 300 patients of dyslipidemia or coronary artery disease on stable doses of atorvastatin. These patients met their respective NCEP-ATPIII cholesterol goals and were randomized to receive the same doses of atorvastatin every day (QD) or every other day (QOD) in a 1:1 ratio for 12 weeks. The efficacy criteria were (1) proportion of patients maintaining the low-density lipoprotein-cholesterol (LDL-C) goal, (2) comparison of changes in the total cholesterol, LDL-C, high-density lipoprotein cholesterol, and triglyceride levels from baseline. The proportions of patients maintaining their LDL-C goals in QD and QOD groups at 6 weeks were 83.9% (60.3-97.5) versus 70.9% (59.3-82.5) (P < 0.01) and at 12 weeks were 84.6% (70.9-98.3) versus 73.8% (63.8-83.8) (P < 0.05). Per-protocol analysis showed 95.5% (80.0-111.0) versus 79.1% (66.2-92.0) (P < 0.001) patients at 6 weeks and 91.9% (82.0-106.8) versus 77.4% (64.8-90) (P < 0.05) patients at 12 weeks had maintained their LDL-C goals in the QD and QOD groups. A significant increase was observed in the levels of total cholesterol, LDL-C, and triglyceride at 6 and 12 weeks compared with baseline values in the QOD group. Alternate-day treatment of atorvastatin was inferior to daily treatment in maintaining the NCEP-ATPIII goal.
阿托伐他汀的 3-羟基-3-甲基戊二酰辅酶 A 还原酶抑制活性可持续长达 20-30 小时。本研究旨在比较隔日治疗与每日治疗对维持国家胆固醇教育计划成人治疗专家组 III 版(NCEP-ATPIII)目标的效果。这项随机、开放标签试验纳入了 300 例正在服用稳定剂量阿托伐他汀的血脂异常或冠心病患者。这些患者达到了各自的 NCEP-ATPIII 胆固醇目标,并按 1:1 的比例随机分为每日(QD)或隔日(QOD)接受相同剂量阿托伐他汀治疗,持续 12 周。疗效标准为:(1)维持低密度脂蛋白胆固醇(LDL-C)目标的患者比例;(2)比较从基线开始时的总胆固醇、LDL-C、高密度脂蛋白胆固醇和甘油三酯水平的变化。在第 6 周时,QD 和 QOD 组维持 LDL-C 目标的患者比例分别为 83.9%(60.3-97.5)和 70.9%(59.3-82.5)(P<0.01),在第 12 周时分别为 84.6%(70.9-98.3)和 73.8%(63.8-83.8)(P<0.05)。按方案分析显示,在第 6 周时,QD 和 QOD 组分别有 95.5%(80.0-111.0)和 79.1%(66.2-92.0)(P<0.001)的患者维持 LDL-C 目标,在第 12 周时分别有 91.9%(82.0-106.8)和 77.4%(64.8-90)(P<0.05)的患者维持 LDL-C 目标。与 QOD 组相比,第 6 和 12 周时总胆固醇、LDL-C 和甘油三酯水平均显著升高。阿托伐他汀隔日治疗在维持 NCEP-ATPIII 目标方面劣于每日治疗。