背景:Bempedoic酸在高脂血症治疗和预防心血管事件方面显示出有希望的潜力。然而,对其药物不良反应的调查仍然很少。本研究旨在利用FDA不良事件报告系统(FAERS)数据库的数据挖掘技术来评估与bempedoic酸相关的不良药物事件(ADE)。
方法:根据药物的上市时间表,我们从FAERS数据库中提取了2020年第四季度至2023年第四季度的数据,用于不成比例分析。
结果:本研究共收集了5,797,543份不良事件病例报告,其中735个与bempedoic酸有关。这些报告涵盖了19个系统器官类(SOC)和22个首选术语(PT)。主要是,肌肉骨骼和神经系统与这些不良事件有关.通过进行PT级筛查,检测到ADE的各种信号,包括肌痛(ROR30.33,PRR28.51,IC4.83,EBGM28.47),关节痛(n=34,ROR6.34,PRR6.09,IC2.61,EBGM6.09),肌腱疾病(ROR99.57,PRR98.75,IC6.62,EBGM98.28),和头晕(ROR3.18,PRR3.13,IC1.65,EBGM3.13)。特别值得注意的是高血压危机(ROR28.63,PRR28.51,IC4.83,EBGM28.47),表现出强大的信号强度,以前在临床研究和药物标签中未报道的观察结果。
结论:虽然我们的结果与药物规格基本一致,几个新的不良反应信号,比如高血压危机,以前没有记录。因此,需要进一步的调查来评估这些未标记的不良反应,为bempedoicacid的临床应用提供关键支持。
BACKGROUND: Bempedoic acid exhibits promising potential in hyperlipidemia therapy and preventing cardiovascular events. However, investigations into its adverse drug reactions remain scant. This study seeks to utilize data mining techniques with the FDA Adverse Event Reporting System (FAERS) database to assess adverse drug events (ADEs) linked to bempedoic acid.
METHODS: Based on the drug\'s market release timeline, we extracted data from the FAERS database covering the fourth quarter of 2020 through the fourth quarter of 2023 for disproportionality analysis.
RESULTS: This study gathered a total of 5,797,543 adverse event case reports, of which 735 were linked to bempedoic acid. These reports covered 19 System Organ Classes (SOCs) and 22 Preferred Terms (PTs). Predominantly, the musculoskeletal and nervous systems were implicated in these adverse events. By conducting PT-level screening, various signals for ADEs were detected, including myalgia (ROR 30.33, PRR 28.51, IC 4.83, EBGM 28.47), arthralgia (n = 34, ROR 6.34, PRR 6.09, IC 2.61, EBGM 6.09), tendon disorders (ROR 99.57, PRR 98.75, IC 6.62, EBGM 98.28), and dizziness (ROR 3.18, PRR 3.13, IC 1.65, EBGM 3.13). Particularly noteworthy was the hypertensive crisis (ROR 28.63, PRR 28.51, IC 4.83, EBGM 28.47), which exhibited a robust signal strength, an observation previously unreported in clinical studies and drug labeling.
CONCLUSIONS: While our results are largely consistent with the drug\'s specifications, several new adverse reaction signals, such as hypertensive crisis, have not been previously documented. Therefore, further investigations are necessary to assess these unlabeled adverse reactions, offering crucial support for the clinical utilization of bempedoic acid.