Andréjak Michel, Gras Valérie, Massy Ziad A, Caron Jacques
Service de Pharmacologie Clinique, Hôpital Sud, avenue R. Laënec Salouel, CHU Amiens, 80054 Amiens, France.
Therapie. 2003 Jan-Feb;58(1):77-83. doi: 10.2515/therapie:2003011.
The safety of the hydroxymethyl glutaryl-coenzyme A reductase inhibitors (statins) has been called into question following the recent withdrawal from the market of one of the class, cerivastatin. The withdrawal of cerivastatin highlighted concerns regarding the safety of the entire class. According to data from several large clinical trials, the statins (except cerivastatin) are well tolerated. The most important and clinically relevant adverse effect reported with statins is myopathy. Myopathy is a clinical diagnosis of elevated creatine phosphokinase and/or myalgia along with fatigue. However, the severe from (i.e. statin-associated rhabdomyolysis) is an uncommon syndrome and occurs at a rate of approximately 1/100,000 patients/years. Statin-associated myopathy is related to statin doses, and often to drug/drug interactions. Other clinically relevant adverse effects associated with statin therapy include liver transminases elevation, which is relatively mild and often self-limiting There is no evidence from clinical trials of a significant alteration of ophthalmological function with statins. The issue of statin-induced cancer remains inconclusive. Overall, the statins seem to exhibit a favourable risk/benefit ratio, and this undoubtedly justifies life-long clinical use of statins for cardiovascular prevention.
随着羟甲基戊二酰辅酶A还原酶抑制剂（他汀类药物）中的西立伐他汀最近退市，该类药物的安全性受到了质疑。西立伐他汀的退市凸显了对整个他汀类药物安全性的担忧。根据几项大型临床试验的数据，他汀类药物（除西立伐他汀外）耐受性良好。他汀类药物报告的最重要且与临床相关的不良反应是肌病。肌病是一种临床诊断，表现为肌酸磷酸激酶升高和/或肌痛伴疲劳。然而，严重形式（即他汀类药物相关的横纹肌溶解症）是一种罕见综合征，发生率约为每年1/100,000患者。他汀类药物相关的肌病与他汀类药物剂量有关，且常常与药物相互作用有关。与他汀类药物治疗相关的其他临床相关不良反应包括肝转氨酶升高，这相对较轻且通常为自限性。临床试验中没有证据表明他汀类药物会显著改变眼科功能。他汀类药物诱发癌症的问题尚无定论。总体而言，他汀类药物似乎具有良好的风险/效益比，这无疑证明了他汀类药物在心血管预防方面终身临床使用的合理性。
