Blasetto James W, Stein Evan A, Brown W Virgil, Chitra Rohini, Raza Ali
AstraZeneca LP, Wilmington, Delaware 19850, USA.
Am J Cardiol. 2003 Mar 6;91(5A):3C-10C; discussion 10C. doi: 10.1016/s0002-9149(03)00003-1.
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.
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。