Prescrire Int. 2007 Apr;16(88):68-9.
(1) Rosuvastatin was not evaluated for its impact on morbidity or mortality. In premarketing trials its adverse effects seemed similar to those observed with other statins. In addition, there were questions concerning renal adverse effects, particularly dose-dependent proteinuria. Inadequate information was available to know whether the risk of rhabdomyolysis differed from that of other statins. (2) A review of adverse events reported to the FDA in late 2004 showed that reports of renal and muscular adverse events were more frequent with rosuvastatin than with other statins currently on the market. (3) Regulatory agencies analysed their results and issued warnings, but they withheld the raw data. This is regrettable, especially given the frequent use of the drug, the specific risks associated with this class, and the questions that were left unanswered in its initial clinical evaluation. Healthcare professionals and the public need access to more precise data on rosuvastatin. (4) In practice, it is better to select the two statins with the most thorough clinical assessments, namely simvastatin and pravastatin.
(1) 瑞舒伐他汀对发病率或死亡率的影响未作评估。在上市前试验中，其不良反应似乎与其他他汀类药物观察到的相似。此外，存在关于肾脏不良反应的问题，尤其是剂量依赖性蛋白尿。尚无足够信息了解横纹肌溶解症的风险与其他他汀类药物是否不同。(2) 对2004年末向美国食品药品监督管理局（FDA）报告的不良事件的一项审查显示，与目前市场上的其他他汀类药物相比，瑞舒伐他汀的肾脏和肌肉不良事件报告更为频繁。(3) 监管机构分析了结果并发布了警告，但他们隐瞒了原始数据。这令人遗憾，特别是考虑到该药物的频繁使用、该类药物相关的特定风险以及其初始临床评估中未解答的问题。医疗保健专业人员和公众需要获取关于瑞舒伐他汀更精确的数据。(4) 在实践中，最好选择临床评估最全面的两种他汀类药物，即辛伐他汀和普伐他汀。
