Safety of fibrates in cholestatic liver diseases
Safety of fibrates in cholestatic liver diseases
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DOI：
10.1111/liv.14871
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发表时间：
2021-03-18
影响因子：
6.7
通讯作者：
Levy, Cynthia
中科院分区：
文献类型：
--
作者：
Carrion, Andres F.;Lindor, Keith D.;Levy, Cynthia
背景和目的 胆汁淤积性肝病患者超说明书使用贝特类药物可改善生化参数和瘙痒；然而，他们在这群人中的安全一直令人担忧。本研究总结了贝特类药物用于治疗胆汁淤积性肝病时的安全性数据。方法对已发表的评估贝特类药物治疗原发性胆汁性胆管炎（PBC）和原发性硬化性胆管炎（PSC）的研究进行了系统回顾。检索了截至 2019 年 12 月的电子数据库，以查找评估贝特类药物对这 2 种疾病相关治疗结果的已发表研究。 结果 共找到 37 项研究，其中 31 项针对 PBC，6 项针对 PSC，共有 1107 名接受贝特类+/-熊去氧胆酸 (UDCA) 治疗的独特患者。大多数研究评估了非诺贝特和苯扎贝特，只有 1 项研究评估了培马贝特。没有研究评估吉非贝齐或氯贝丁酯。最常见的不良事件（AE）是胃肠道和肌肉骨骼。与 UDCA 单药治疗相比，接受 UDCA 加贝特类药物治疗的患者更常见转氨酶和血清肌酐升高。 结论 贝特类药物对于 PBC 患者似乎是安全的且耐受性良好，且 AE 发生率较低。关于这些药物治疗 PSC 的安全性的数据很少。
Background and aim Off-label use of fibrates in patients with cholestatic liver diseases results in improved biochemical parameters and pruritus; however, their safety in this population has been a concern. This study summarizes safety data for fibrates when used for treatment of cholestatic liver diseases.Methods A systematic review of published studies evaluating the use of fibrates for treatment of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) was performed. Electronic databases were searched up to December 2019 for published studies evaluating treatment outcomes associated to fibrates for these 2 diseases.Results A total of 37 studies were identified, including 31 for PBC and 6 for PSC, with a total of 1107 unique patients treated with fibrates +/- ursodeoxycholic acid (UDCA). Most studies evaluated fenofibrate and bezafibrate, and only 1 study evaluated pemafibrate. There were no studies evaluating gemfibrozil or clofibrate. The most commonly reported adverse events (AEs) were gastrointestinal and musculoskeletal. Elevations of aminotransferases and serum creatinine were reported more commonly in patients treated with UDCA plus fibrates versus UDCA monotherapy.Conclusions Fibrates appear to be safe and well tolerated in patients with PBC, with a low frequency of AEs. There are scarce data about the safety of these agents for treatment of PSC.