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围绕西立伐他汀安全性的争议。

Controversy surrounding the safety of cerivastatin.

作者信息

Davidson Michael H

出版信息

Expert Opin Drug Saf. 2002 Sep;1(3):207-12. doi: 10.1517/14740338.1.3.207.

DOI:10.1517/14740338.1.3.207
PMID:12904136
Abstract

The noted myotoxicity and subsequent withdrawal of cerivastatin from the worldwide market in August 2001 has demonstrated that the safety of statins is not a class effect. The total rhabdomyolysis rate for cerivastatin was 16 - 80 times more frequent than with other statins without providing additional efficacy. Cerivastatin has a pharmacokinetic profile (high potency, bioavailability, lipophilicity and renal excretion) that is different from other statins, which may explain the high myotoxicity rate. The cerivastatin experience has also provided insights into high-risk populations (i.e., the elderly, women, those with renal impairment, co-administration of interacting drugs) that are more prone to statin-induced myopathy. Ultimately, the lessons learned from this experience may significantly improve the safety of statin use in the future.

摘要

2001年8月,西立伐他汀显著的肌毒性以及随后在全球市场的撤市表明,他汀类药物的安全性并非类效应。西立伐他汀的横纹肌溶解总发生率比其他他汀类药物高16至80倍,且未提供额外的疗效。西立伐他汀具有与其他他汀类药物不同的药代动力学特征(高效能、生物利用度、亲脂性和经肾排泄),这可能解释了其高肌毒性发生率。西立伐他汀的经验还为更易发生他汀类药物所致肌病的高危人群(即老年人、女性、肾功能损害者、联用相互作用药物者)提供了见解。最终,从这一经验中吸取的教训可能会在未来显著提高他汀类药物使用的安全性。

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Controversy surrounding the safety of cerivastatin.围绕西立伐他汀安全性的争议。
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2
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[Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States].[西立伐他汀的撤市揭示了美国上市后监测系统的一个缺陷]
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Safety considerations for statins.他汀类药物的安全性考量
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