Benefit-risk assessment of rosuvastatin 10 to 40 milligrams
Benefit-risk assessment of rosuvastatin 10 to 40 milligrams
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DOI：
10.1016/s0002-9149(03)00779-3
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发表时间：
2003-08-21
影响因子：
2.8
通讯作者：
Brewer, HB
中科院分区：
文献类型：
--
作者：
Brewer, HB
本文的目的是检查瑞舒伐他汀在10 - 40 mg剂量下的获益-风险特征。在血脂异常患者中，与阿托伐他汀、辛伐他汀和普伐他汀相比，瑞舒伐他汀使低密度脂蛋白（LDL）胆固醇显著降低，并使各种血脂指标（包括高密度脂蛋白（HDL）胆固醇、非HDL胆固醇和甘油三酯）得到同等或更大的改善。此外，瑞舒伐他汀在使患者达到国家胆固醇教育计划（NCEP）成人治疗组（ATP）III和欧洲联合学会LDL胆固醇目标方面比这些他汀类药物更有效。在12，569例患者中审查了瑞舒伐他汀的安全性特征（截至2003年4月），代表剂量高达80 mg的14，231患者-年治疗。在对照试验中，瑞舒伐他汀10 - 40 mg显示出与阿托伐他汀10 - 80 mg、辛伐他汀10 - 80 mg和普伐他汀10 - 40 mg相似的不良事件特征。在接受瑞舒伐他汀10 - 40 mg治疗的患者中，小于或等于0.03%的患者发生归因于瑞舒伐他汀的肌病（定义为肌肉症状加血清肌酸激酶水平>正常值上限的10倍）。在接受瑞舒伐他汀10 - 40 mg的患者中未发生横纹肌溶解症病例。在接受瑞舒伐他汀和接受阿托伐他汀、辛伐他汀和普伐他汀的患者中，0.2%的患者发生具有临床意义的丙氨酸氨基转移酶升高。与其他广泛使用的他汀类药物相比，瑞舒伐他汀10 - 40 mg的获益-风险特征似乎非常有利。(C)2003年，Excerpta Medica，Inc.
The aim of this article is to examine the benefit-risk profile of rosuvastatin at doses of 10 to 40 mg. In dyslipidemic patients, rosuvastatin produced markedly greater reductions in low-density lipoprotein (LDL) cholesterol and equivalent or greater improvements in various lipid measures, including high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, and triglycerides when compared with atorvastatin, simvastatin, and pravastatin. In addition, rosuvastatin is more effective than these statins in allowing patients to reach National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III and Joint European Societies LDL cholesterol goals. The safety profile of rosuvastatin was reviewed (as of April 2003) in 12,569 patients, representing 14,231 patient-years of treatment at doses up to 80 mg. In controlled trials, rosuvastatin 10 to 40 mg demonstrated a similar adverse event profile to those for atorvastatin 10 to 80 mg, simvastatin 10 to 80 mg, and pravastatin 10 to 40 mg. Myopathy (defined as muscle symptoms plus serum creatine kinase levels > 10 times the upper limit of normal) attributed to rosuvastatin occurred in less than or equal to 0.03% of patients receiving rosuvastatin 10 to 40 mg. No cases of rhabdomyolysis occurred in patients receiving rosuvastatin 10 to 40 mg. Clinically significant alanine aminotransferase elevations occurred in 0.2% of patients receiving rosuvastatin and those receiving atorvastatin, simvastatin, and provastatin. Compared with other widely used statins, the benefit-risk profile of rosuvastatin 10 to 40 mg appears to be very favorable. (C) 2003 by Excerpta Medica, Inc.