Schneck Dennis W, Knopp Robert H, Ballantyne Christie M, McPherson Ruth, Chitra Rohini R, Simonson Steven G
AstraZeneca LP, Wilmington, Delaware 19850-5437, USA.
Am J Cardiol. 2003 Jan 1;91(1):33-41. doi: 10.1016/s0002-9149(02)02994-6.
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.
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。