Department of Pharmacy, Henan Provincial People's Hospital, Zhengzhou, China.
Department of Pharmacognosy, School of Pharmaceutical Science, Zhengzhou University, Zhengzhou, China.
Expert Opin Drug Saf. 2024 Mar;23(3):373-383. doi: 10.1080/14740338.2023.2274946. Epub 2023 Oct 27.
The triglyceride-lowering drug, icosapent ethyl (IPE), was granted a new indication for the reduction of atherosclerotic cardiovascular disease risk in 2019. This study aimed to investigate the safety profile of IPE by mining the FDA Adverse Event Reporting System (FAERS) database.
The reporting odds ratio was used to analyze IPE's adverse events (AEs) based on the FAERS data from July 2012 to December 2022. We described the characteristics of AE reports and evaluated the clinical prioritization of AEs. Then we defined and analyzed nine interested adverse drug reactions (ADRs) in both overall and subgroups, and investigated the times to onset.
The findings of our study strengthen the evidence for an increased risk of atrial fibrillation using IPE. IPE alone may not increase the risk of bleeding unless combined with antithrombotic drugs. Similar to statins, IPE alone can increase the risk of musculoskeletal pain, drug-related hepatic disorders, and hyperglycemia, but the risk could not double when IPE was combined with statins. Most ADRs occur in the early stage of treatment.
This study provides a comprehensive real-world safety profile of IPE, which indicates that IPE is well-tolerated.
降低甘油三酯的药物依泽替米贝（IPE）于 2019 年获得了降低动脉粥样硬化性心血管疾病风险的新适应证。本研究旨在通过挖掘 FDA 不良事件报告系统（FAERS）数据库来研究 IPE 的安全性概况。
我们根据 2012 年 7 月至 2022 年 12 月的 FAERS 数据，使用报告比值比分析 IPE 的不良事件（AE）。我们描述了 AE 报告的特征，并评估了 AE 的临床优先顺序。然后，我们在整体和亚组中定义和分析了 9 种感兴趣的药物不良反应（ADR），并调查了发病时间。
我们的研究结果强化了使用 IPE 会增加心房颤动风险的证据。单独使用 IPE 不一定会增加出血风险，除非与抗血栓药物联合使用。与他汀类药物类似，单独使用 IPE 会增加肌肉骨骼疼痛、与药物相关的肝疾病和高血糖的风险，但当 IPE 与他汀类药物联合使用时，风险不会翻倍。大多数 ADR 发生在治疗的早期阶段。
本研究提供了 IPE 的全面真实世界安全性概况，表明 IPE 具有良好的耐受性。
