Division of Cardiology, Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.
Ann Pharmacother. 2010 Mar;44(3):415-23. doi: 10.1345/aph.1M522. Epub 2010 Feb 23.
Previous studies have shown conflicting results on low-density lipoprotein cholesterol (LDL-C) reduction for comparable doses of pitavastatin and atorvastatin.
To compare the efficacy of pitavastatin 1 mg once daily with that of atorvastatin 10 mg once daily on lipoprotein change, safety, and cost per percent LDL-C reduction.
An 8-week, randomized, open-label, parallel trial was conducted in patients with hypercholesterolemia. One hundred patients were equally randomized to receive pitavastatin 1 mg once daily or atorvastatin 10 mg once daily; 98 completed the study. Outcomes were assessed at baseline and at the end of the study.
Pitavastatin lowered LDL-C levels from baseline by 37% compared with 46% in the atorvastatin group (p < 0.001). The reduction of total cholesterol (TC) levels from baseline was significantly different between the pitavastatin (28%) and atorvastatin (32%) groups (p = 0.005). There was no significant difference in the percentage of changes in triglyceride and high-density lipoprotein cholesterol levels between groups. The percentage of patients who achieved LDL-C goals according to National Cholesterol Education Program-Adult Treatment Panel III guidelines was not significantly different between the pitavastatin (74%) and atorvastatin (84%) groups (p = 0.220). In addition, both regimens were well tolerated, with no patient developing an elevation of more than 3 times the upper normal limit of alanine aminotransferase or 10 times that of creatine kinase. The monthly cost per percent LDL-C reduction in the pitavastatin group ($0.77) was about 50% lower than the cost in the atorvastatin ($1.56) group.
Although pitavastatin 1 mg daily was not as effective at lowering LDL-C and TC levels as atorvastatin 10 mg daily, the number of patients achieving their LDL-C goals with pitavastatin was comparable with the number using atorvastatin. Pitavastatin 1 mg once daily may be an alternative regimen with cost-saving benefits but without a significant decrease in therapeutic benefit or increase in adverse events in patients with hypercholesterolemia.
先前的研究表明，在比较匹伐他汀和阿托伐他汀相当剂量时，低密度脂蛋白胆固醇（LDL-C）的降低效果存在矛盾。
比较每日一次 1 毫克匹伐他汀和每日一次 10 毫克阿托伐他汀在脂蛋白变化、安全性和每降低百分之一 LDL-C 的成本方面的疗效。
一项为期 8 周的、随机、开放标签、平行试验在高胆固醇血症患者中进行。100 名患者被随机等分为每日一次接受匹伐他汀 1 毫克或阿托伐他汀 10 毫克；98 名患者完成了研究。在基线和研究结束时评估结局。
与阿托伐他汀组（46%）相比，匹伐他汀组 LDL-C 水平从基线降低了 37%（p < 0.001）。与阿托伐他汀组（32%）相比，匹伐他汀组（28%）的总胆固醇（TC）水平从基线的降低有显著差异（p = 0.005）。两组间甘油三酯和高密度脂蛋白胆固醇水平的变化百分比无显著差异。根据国家胆固醇教育计划-成人治疗专家组 III 指南，达到 LDL-C 目标的患者百分比在匹伐他汀组（74%）和阿托伐他汀组（84%）之间无显著差异（p = 0.220）。此外，两种方案均耐受良好，无患者丙氨酸氨基转移酶升高超过正常上限 3 倍或肌酸激酶升高超过正常上限 10 倍。匹伐他汀组每降低百分之一 LDL-C 的每月成本（0.77 美元）比阿托伐他汀组（1.56 美元）低约 50%。
虽然每日 1 毫克匹伐他汀降低 LDL-C 和 TC 水平的效果不如每日 10 毫克阿托伐他汀，但使用匹伐他汀达到 LDL-C 目标的患者数量与使用阿托伐他汀的患者数量相当。每日一次 1 毫克匹伐他汀可能是一种替代方案，具有节省成本的优势，但在高胆固醇血症患者中，不会降低治疗效果或增加不良反应。
