A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class.
A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class.
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DOI：
10.1371/journal.pone.0042866
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Golomb BA
中科院分区：
文献类型：
--
作者：
Hoffman KB;Kraus C;Dimbil M;Golomb BA
被称为他汀类药物的胆固醇管理药物被广泛使用，而且往往耐受性良好；然而，可能会出现各种与肌肉相关的副作用。这些不良事件(AEs)可能会产生严重影响，并对坚持治疗形成重大障碍。监测上市后的不良反应对于了解真实世界的不良反应和报告个别他汀类药物之间的差异至关重要。我们对与他汀类药物使用相关的批准后肌肉和肌腱声发射报告进行了审查，以评估药物类别内的差异。我们分析了FDA AE报告系统(AERS)数据库中的所有病例报告，这些数据库将肌肉相关的AEs与他汀类药物的使用联系在一起(2011年7月1日-2005年3月31日)。检查的药物有：阿托伐他汀、辛伐他汀、洛伐他汀、普伐他汀、瑞舒伐他汀和氟伐他汀。瑞舒伐他汀的相对风险率始终高于其他他汀类药物。阿托伐他汀和辛伐他汀显示中等风险，而普伐他汀和洛伐他汀的风险似乎最低。因此，肌肉相关不良反应的相对风险大约与每毫克降低低密度脂蛋白的效力有关，氟伐他汀是一个明显的例外。结合所有肌肉类别，阿托伐他汀、辛伐他汀、普伐他汀和洛伐他汀的发生率分别为55%、26%、17%和7.5%，与瑞舒伐他汀一样高，大约跟踪每毫克效力(Rosuvastatin>；Atorvastatin>；Simvastatin>；Pravastatin≈Lovastatin)，与其他研究的结果一致。因此，相对效力似乎是肌肉相关的AE风险的基本预测指标，氟伐他汀是效力最低的他汀类药物，显然是一个例外(风险74%比瑞舒伐他汀)。他汀类药物的AE报告率差异显著，相对报告率与效力基本一致。这份报告中提供的数据为选择他汀类药物进行胆固醇管理提供了重要的参考点，特别是对于经历过肌肉相关不良反应的患者的再挑战(对他们来说，应该首选预期效价较低的药物)。
Cholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. These adverse events (AEs) can have serious impact, and form a significant barrier to therapy adherence. Surveillance of post-marketing AEs is of vital importance to understand real-world AEs and reporting differences between individual statin drugs. We conducted a review of post-approval muscle and tendon AE reports in association with statin use, to assess differences within the drug class. We analyzed all case reports from the FDA AE Reporting System (AERS) database linking muscle-related AEs to statin use (07/01/2005–03/31/2011). Drugs examined were: atorvastatin, simvastatin, lovastatin, pravastatin, rosuvastatin, and fluvastatin. Relative risk rates for rosuvastatin were consistently higher than other statins. Atorvastatin and simvastatin showed intermediate risks, while pravastatin and lovastatin appeared to have the lowest risk rates. Relative risk of muscle-related AEs, therefore, approximately tracked with per milligram LDL-lowering potency, with fluvastatin an apparent exception. Incorporating all muscle categories, rates for atorvastatin, simvastatin, pravastatin, and lovastatin were, respectively, 55%, 26%, 17%, and 7.5% as high, as rosuvastatin, approximately tracking per milligram potency (Rosuvastatin>Atorvastatin>Simvastatin>Pravastatin≈Lovastatin) and comporting with findings of other studies. Relative potency, therefore, appears to be a fundamental predictor of muscle-related AE risk, with fluvastatin, the least potent statin, an apparent exception (risk 74% vs rosuvastatin). AE reporting rates differed strikingly for drugs within the statin class, with relative reporting aligning substantially with potency. The data presented in this report offer important reference points for the selection of statins for cholesterol management in general and, especially, for the rechallenge of patients who have experienced muscle-related AEs (for whom agents of lower expected potency should be preferred).
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