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瑞舒伐他汀与其他他汀类药物在高胆固醇血症患者及特殊人群组中选定起始剂量时的疗效比较。

Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups.

作者信息

Blasetto James W, Stein Evan A, Brown W Virgil, Chitra Rohini, Raza Ali

机构信息

AstraZeneca LP, Wilmington, Delaware 19850, USA.

出版信息

Am J Cardiol. 2003 Mar 6;91(5A):3C-10C; discussion 10C. doi: 10.1016/s0002-9149(03)00003-1.

DOI:10.1016/s0002-9149(03)00003-1
PMID:12646336
Abstract

A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p <0.001). Treatment with rosuvastatin 5 mg (n = 240) and 10 mg (n = 226) also resulted in significantly greater reductions in LDL cholesterol compared with both simvastatin 20 mg (n = 249) and pravastatin 20 mg (n = 252) (40.6% and 48.1% vs 27.1% and 35.7%, all p <0.001). Significant differences favoring rosuvastatin 10 mg were also observed for total cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, apolipoprotein (apo) B, and apo A-I versus atorvastatin 10 mg, and for total cholesterol, HDL cholesterol, triglycerides, non-HDL cholesterol, and apo B versus simvastatin 20 mg and pravastatin 20 mg. Analyses of all the rosuvastatin 10 mg data (n = 615) from the 5 trials in subgroups defined by age > or =65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that rosuvastatin had consistent efficacy across patient subgroups.

摘要

共有5项针对高胆固醇血症患者的随机双盲试验进行了前瞻性设计,以便在治疗12周后汇总血浆脂质数据。目的是:(1)比较瑞舒伐他汀5毫克和10毫克与阿托伐他汀10毫克(5项试验中的3项的数据);(2)比较瑞舒伐他汀5毫克和10毫克与辛伐他汀20毫克和普伐他汀20毫克(5项试验中的2项的数据);(3)总结所有5项试验中瑞舒伐他汀数据的总体疗效和亚组分析。瑞舒伐他汀5毫克(n = 390)和10毫克(n = 389)降低低密度脂蛋白(LDL)胆固醇的幅度显著大于阿托伐他汀10毫克(n = 393)(分别为41.9%和46.7%对36.4%,p均<0.001)。与辛伐他汀20毫克(n = 249)和普伐他汀20毫克(n = 252)相比,瑞舒伐他汀5毫克(n = 240)和10毫克(n = 226)治疗也使LDL胆固醇降低幅度显著更大(分别为40.6%和48.1%对27.1%和35.7%,p均<0.001)。在总胆固醇、高密度脂蛋白(HDL)胆固醇、非HDL胆固醇、载脂蛋白(apo)B和apo A-I方面,与阿托伐他汀10毫克相比,以及在总胆固醇、HDL胆固醇、甘油三酯、非HDL胆固醇和apo B方面,与辛伐他汀20毫克和普伐他汀20毫克相比,也观察到有利于瑞舒伐他汀10毫克的显著差异。对5项试验中所有瑞舒伐他汀10毫克数据(n = 615)在年龄≥65岁、女性、绝经后状态、高血压、动脉粥样硬化、2型糖尿病和肥胖定义的亚组中的分析表明,瑞舒伐他汀在各患者亚组中具有一致的疗效。

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