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瑞舒伐他汀和阿托伐他汀在不同剂量范围内对无活动性动脉疾病的高胆固醇血症患者的比较效果。

Comparative effects of rosuvastatin and atorvastatin across their dose ranges in patients with hypercholesterolemia and without active arterial disease.

作者信息

Schneck Dennis W, Knopp Robert H, Ballantyne Christie M, McPherson Ruth, Chitra Rohini R, Simonson Steven G

机构信息

AstraZeneca LP, Wilmington, Delaware 19850-5437, USA.

出版信息

Am J Cardiol. 2003 Jan 1;91(1):33-41. doi: 10.1016/s0002-9149(02)02994-6.

Abstract

The lipid-lowering effects of rosuvastatin and atorvastatin were determined across their dose ranges in a 6-week, randomized, double-blind trial. Three hundred seventy-four hypercholesterolemic patients with fasting low-density lipoprotein (LDL) cholesterol > or =160 but <250 mg/dl (> or =4.14 but <6.47 mmol/L) and fasting triglycerides <400 mg/dl (<4.52 mmol/L) and without active arterial disease within 3 months of entry received once-daily rosuvastatin (5, 10, 20, 40, or 80 mg [n = 209]) or atorvastatin (10, 20, 40, or 80 mg [n = 165]). The percentage decrease in plasma LDL cholesterol versus dose was log-linear for each drug, ranging from -46.6% to -61.9% for rosuvastatin 10 and 80 mg, compared with -38.2% to -53.5% for atorvastatin 10 and 80 mg. The dose curve for rosuvastatin yielded an 8.4% greater decrease in LDL cholesterol compared with atorvastatin at any given dose (p <0.001). Similarly greater decreases were observed for rosuvastatin across the dose range in total cholesterol (-4.9%), non-high-density lipoprotein (non-HDL) cholesterol (-7.0%), apolipoprotein B (-6.3%), and related ratios versus atorvastatin (all p <0.001). Because dose responses for HDL cholesterol, triglycerides, and apolipoprotein A-I were non-log-linear and nonparallel between the 2 drugs, percentage changes from baseline were compared at each dose. Significantly greater increases for rosuvastatin compared with atorvastatin were observed for HDL cholesterol at 40 and 80 mg, and for apolipoprotein A-I at 80 mg. Significantly greater triglyceride decreases were seen at 80 mg with atorvastatin over rosuvastatin. Both rosuvastatin and atorvastatin were well tolerated over 6 weeks.

摘要

在一项为期6周的随机双盲试验中,测定了瑞舒伐他汀和阿托伐他汀在其剂量范围内的降脂效果。374例空腹低密度脂蛋白(LDL)胆固醇≥160但<250mg/dl(≥4.14但<6.47mmol/L)、空腹甘油三酯<400mg/dl(<4.52mmol/L)且在入组3个月内无活动性动脉疾病的高胆固醇血症患者,接受每日一次的瑞舒伐他汀(5、10、20、40或80mg[n = 209])或阿托伐他汀(10、20、40或80mg[n = 165])治疗。每种药物的血浆LDL胆固醇降低百分比与剂量呈对数线性关系,瑞舒伐他汀10mg和80mg的降低幅度为-46.6%至-61.9%,阿托伐他汀10mg和80mg的降低幅度为-38.2%至-53.5%。在任何给定剂量下,瑞舒伐他汀的剂量曲线使LDL胆固醇降低幅度比阿托伐他汀大8.4%(p<0.001)。在总胆固醇(-4.9%)、非高密度脂蛋白(非HDL)胆固醇(-7.0%)、载脂蛋白B(-6.3%)以及相关比率方面,瑞舒伐他汀在整个剂量范围内的降低幅度也比阿托伐他汀更大(所有p<0.001)。由于两种药物的高密度脂蛋白胆固醇、甘油三酯和载脂蛋白A-I的剂量反应是非对数线性且不平行的,因此比较了各剂量下相对于基线的百分比变化。瑞舒伐他汀在40mg和80mg时的高密度脂蛋白胆固醇以及80mg时的载脂蛋白A-I相对于阿托伐他汀有显著更大的升高。阿托伐他汀在80mg时的甘油三酯降低幅度比瑞舒伐他汀显著更大。瑞舒伐他汀和阿托伐他汀在6周内耐受性均良好。

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