Withdrawal of cerivastatin from the world market.
Withdrawal of cerivastatin from the world market.
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DOI：
10.1186/cvm-2-5-205
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发表时间：
2001
影响因子：
--
通讯作者：
Pitt B
中科院分区：
文献类型：
--
作者：
Furberg CD;Pitt B
西立伐他汀最近被从市场上撤回，因为52人死于与药物相关的横纹肌溶解，导致肾功能衰竭。在接受全剂量(0.8毫克/天)和同时接受吉非罗齐治疗的患者中，发现风险更高。与其他五种批准的他汀类药物相比，西立伐他汀治疗横纹肌溶解的发生率高出10倍。我们讨论了这次撤军提出的三个重要问题。我们是否应该继续批准具有替代疗效的药物？所有的他汀类药物都可以互换吗？他汀类药物的益处是否大于风险？我们的结论是，关于药物使用的决定应该基于长期临床结果试验的直接证据。
Cerivastatin was recently withdrawn from the market because of 52 deaths attributed to drug-related rhabdomyolysis that lead to kidney failure. The risk was found to be higher among patients who received the full dose (0.8 mg/day) and those who received gemfibrozil concomitantly. Rhabdomyolysis was 10 times more common with cerivastatin than the other five approved statins. We address three important questions raised by this withdrawal. Should we continue to approve drugs on surrogate efficacy? Are all statins interchangeable? Do the benefits outweigh the risks of statins? We conclude that decisions regarding the use of drugs should be based on direct evidence from long-term clinical outcome trials.
影响因子：
158.5
作者：
Rubins, HB;Robins, SJ;Wittes, J
通讯作者：
Wittes, J
影响因子：
37.8
作者：
Schlesinger, Z;Vered, Z;Henkin, J
通讯作者：
Henkin, J
影响因子：
--
作者：
D'Agostino, Ralph B Jr
通讯作者：
D'Agostino, Ralph B Jr