Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.
Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.
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DOI：
10.1371/journal.pone.0028124
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发表时间：
2011
期刊：
影响因子：
3.7
通讯作者：
Okuno Y
中科院分区：
文献类型：
--
作者：
Sakaeda T;Kadoyama K;Okuno Y
对提交给美国食品药品监督管理局（FDA）的不良事件报告（AER）进行了审查，以评估3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂（他汀类药物）给药诱导的肌肉和肾脏不良事件，并尝试确定相关性的等级顺序。在修订任意药物名称并删除重复提交资料后，分析了涉及普伐他汀、辛伐他汀、阿托伐他汀或瑞舒伐他汀的AER。使用授权的药物警戒工具定量检测信号，即，药物相关不良事件，包括比例报告比、报告比值比、贝叶斯置信传播神经网络给出的信息分量和经验贝叶斯几何平均值。肌痛、横纹肌溶解症和肌酸磷酸激酶水平升高是肌肉不良事件，急性肾衰竭、非急性肾衰竭和血肌酐水平升高是肾脏不良事件。基于2004年至2009年的1，644，220例AER，检测到4种他汀类药物的肌痛、横纹肌溶解和肌酸磷酸激酶水平升高信号，但瑞舒伐他汀的这些信号比普伐他汀和阿托伐他汀更强。还检测到急性肾衰竭的信号，尽管在阿托伐他汀的情况下，相关性是轻微的，此外，未检测到非急性肾衰竭或血肌酐水平升高的信号。FDA不良事件报告系统AERS的数据挖掘对于检查他汀类药物相关的肌肉和肾脏不良事件是有用的。这些数据强烈表明，有必要对他汀类药物相关不良事件进行组织良好的临床研究。
Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association. After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.
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