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瑞舒伐他汀与阿托伐他汀利弊比较:来自头对头随机对照试验的荟萃分析

Comparison of benefits and risks of rosuvastatin versus atorvastatin from a meta-analysis of head-to-head randomized controlled trials.

作者信息

Wlodarczyk John, Sullivan David, Smith Michael

机构信息

John Wlodarczyk Consulting Services, New Lambton, NSW, Australia.

出版信息

Am J Cardiol. 2008 Dec 15;102(12):1654-62. doi: 10.1016/j.amjcard.2008.08.014. Epub 2008 Sep 20.

Abstract

The benefit from statin therapy is proportional to the low-density lipoprotein (LDL) cholesterol reduction. However, adverse events appear to be related to dose rather than LDL cholesterol reduction. Although serious side effects are rare, any comparison of statins requires scrutiny of the relation between therapeutic effect and risk of side effects. This report sought to determine whether the additional LDL cholesterol lowering with rosuvastatin over atorvastatin could be obtained without increased risk of short-term adverse events. Twenty-five studies (approximately 20,000 patients) were identified that provided 28 comparisons of 1:1 dose ratios, 20 comparisons of 1:2 dose ratios, and 6 comparisons of 1:4 dose ratios. Treatment difference in benefit (percentage of LDL cholesterol reduction) and risk (odds ratios for myalgia, increased alanine aminotransferase >3 times the upper limit of normal, creatine kinase >10 times the upper limit of normal, and percentage of change in glomerular filtration rate, as well as deaths, serious adverse events, and withdrawals caused by adverse events) were estimated using meta-analysis and presented in benefit-risk planes. Rosuvastatin was more efficacious than the same dose of atorvastatin (1:1 dose ratio) or a 2 times higher dose (1:2 dose ratio) of atorvastatin. There was no significant difference between rosuvastatin and a 4 times higher dose of atorvastatin (1:4 dose ratio). There were no significant differences between rosuvastatin and atorvastatin at any dose ratio for adverse events. Percentages of change in GFR improved significantly with both treatments. In conclusion, at 1:1 and 1:2 dose ratios, significant additional decreases in LDL cholesterol were obtained using rosuvastatin compared with atorvastatin at a similar risk of the adverse events presented.

摘要

他汀类药物治疗的获益与低密度脂蛋白(LDL)胆固醇降低程度成正比。然而,不良事件似乎与剂量有关,而非LDL胆固醇降低程度。虽然严重副作用罕见,但任何他汀类药物的比较都需要仔细审视治疗效果与副作用风险之间的关系。本报告旨在确定瑞舒伐他汀在不增加短期不良事件风险的情况下,是否能比阿托伐他汀进一步降低LDL胆固醇。共纳入25项研究(约20000例患者),提供了28项1:1剂量比的比较、20项1:2剂量比的比较以及6项1:4剂量比的比较。采用荟萃分析估计获益方面的治疗差异(LDL胆固醇降低百分比)和风险(肌痛、丙氨酸氨基转移酶升高超过正常上限3倍、肌酸激酶升高超过正常上限10倍、肾小球滤过率变化百分比的比值比,以及死亡、严重不良事件和因不良事件导致的撤药情况),并呈现在获益-风险平面上。瑞舒伐他汀比相同剂量的阿托伐他汀(1:1剂量比)或两倍高剂量(1:2剂量比)的阿托伐他汀更有效。瑞舒伐他汀与四倍高剂量的阿托伐他汀(1:4剂量比)之间无显著差异。瑞舒伐他汀和阿托伐他汀在任何剂量比下的不良事件均无显著差异。两种治疗方法的肾小球滤过率变化百分比均显著改善。总之,在1:1和1:2剂量比下,与阿托伐他汀相比,使用瑞舒伐他汀可显著进一步降低LDL胆固醇,且不良事件风险相似。

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