Adverse effects of statin therapy: perception vs. the evidence - focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract.
Adverse effects of statin therapy: perception vs. the evidence - focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract.
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DOI：
10.1093/eurheartj/ehy182
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发表时间：
2018-07-14
影响因子：
39.3
通讯作者：
European Atherosclerosis Society Consensus Panel
中科院分区：
文献类型：
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作者：
Mach F;Ray KK;Wiklund O;Corsini A;Catapano AL;Bruckert E;De Backer G;Hegele RA;Hovingh GK;Jacobson TA;Krauss RM;Laufs U;Leiter LA;März W;Nordestgaard BG;Raal FJ;Roden M;Santos RD;Stein EA;Stroes ES;Thompson PD;Tokgözoglu L;Vladutiu GD;Gencer B;Stock JK;Ginsberg HN;Chapman MJ;European Atherosclerosis Society Consensus Panel
客观评价长期他汀类药物治疗对葡萄糖稳态、认知、肾和肝功能以及出血性卒中或白内障风险可能产生不良影响的证据。进行了涵盖2000-2017年的文献检索。评估小组对数据进行了严格的评估，并以协商一致方式商定了所报告的不利影响的分类。随机对照试验（RCT）和遗传学研究表明，他汀类药物治疗与新发糖尿病风险的适度增加（约每千患者年1例）相关，通常由实验室检查结果（糖化血红蛋白≥6.5）定义;代谢综合征或前驱糖尿病的风险显著更高。他汀类药物治疗不会对认知功能产生不良影响，即使在低密度脂蛋白胆固醇水平非常低的情况下也是如此，并且与临床上显著的肾功能恶化或白内障的发生无关。在0.5-2%的服用他汀类药物的患者中发生肝酶一过性升高，但无临床相关性;他汀类药物引起的特异质肝损伤非常罕见，因果关系难以证明。证据基础不支持无脑血管疾病的个体出血性卒中风险增加;在既往卒中受试者中开展的积极降低胆固醇水平预防卒中研究表明风险略有增加，但尚未在RCT、队列研究和病例对照研究的实质性证据基础中得到证实。长期他汀类药物治疗是非常安全的，具有上述临床相关不良反应的低风险;他汀类药物相关肌肉症状在之前的共识声明中进行了讨论。重要的是，他汀类药物治疗的心血管益处远远超过不良反应的风险。
To objectively appraise evidence for possible adverse effects of long-term statin therapy on glucose homeostasis, cognitive, renal and hepatic function, and risk for haemorrhagic stroke or cataract. A literature search covering 2000–2017 was performed. The Panel critically appraised the data and agreed by consensus on the categorization of reported adverse effects. Randomized controlled trials (RCTs) and genetic studies show that statin therapy is associated with a modest increase in the risk of new-onset diabetes mellitus (about one per thousand patient-years), generally defined by laboratory findings (glycated haemoglobin ≥6.5); this risk is significantly higher in the metabolic syndrome or prediabetes. Statin treatment does not adversely affect cognitive function, even at very low levels of low-density lipoprotein cholesterol and is not associated with clinically significant deterioration of renal function, or development of cataract. Transient increases in liver enzymes occur in 0.5–2% of patients taking statins but are not clinically relevant; idiosyncratic liver injury due to statins is very rare and causality difficult to prove. The evidence base does not support an increased risk of haemorrhagic stroke in individuals without cerebrovascular disease; a small increase in risk was suggested by the Stroke Prevention by Aggressive Reduction of Cholesterol Levels study in subjects with prior stroke but has not been confirmed in the substantive evidence base of RCTs, cohort studies and case–control studies. Long-term statin treatment is remarkably safe with a low risk of clinically relevant adverse effects as defined above; statin-associated muscle symptoms were discussed in a previous Consensus Statement. Importantly, the established cardiovascular benefits of statin therapy far outweigh the risk of adverse effects.