挖掘与 inclisiran 相关的不良事件信号:基于 FAERS 的上市后分析。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-09-30 DOI:10.1080/14740338.2024.2409707
Xuezhong Shi, Ying Qiao, Yongli Yang, Nana Wang, Yi Zhang, Shangxin Shi, Guibin Shen, Xiaocan Jia
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引用次数: 0

摘要

背景:本研究利用美国食品药品管理局不良事件报告系统(FAERS)分析了与替吉瑞林相关的不良事件(AEs):本研究利用 FDA 的不良事件报告系统 (FAERS),分析了与 inclisiran 相关的不良事件 (AEs),以检测和描述相关的安全性信号:我们回顾性地从 FAERS 数据库中提取了 2022 年第一季度至 2024 年第二季度的 AE 报告。我们采用了四种比例失调分析算法来识别 inclisiran 的 AE 信号,随后与 PCSK9 单克隆抗体(alirocumab/evolocumab)进行比较。此外,我们还研究了与 inclisiran 相关的 AE 的特征和发病时间:共有 4122 份报告称 inclisiran 为 "主要疑似药物"。与所有其他药物相比,最重要的系统器官分类(SOC)是 "肌肉骨骼和结缔组织疾病"(ROR = 3.64,PRR = 3.19),最常见的系统器官分类是 "一般疾病和用药部位状况"(n = 2,769)。这两个 SOC 与 inclisiran 的关系比 evolocumab 更密切。在首选术语层面,检测到坏疽性蜂窝组织炎(ROR = 101.29,PRR = 101.27,IC = 6.54,EBGM = 92.91)和膀胱不适(ROR = 12.61,PRR = 12.61,IC = 3.64,EBGM = 12.48)的强烈信号。普利西兰相关AE的中位发病时间为43天(四分位间范围:7-99天):这项研究加深了我们对 inclisiran 相关不良反应的了解。结论:这项研究加深了我们对 inclisiran AEs 的了解,未来对其长期实际应用的研究将有助于深入了解其安全性。
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Mining of adverse event signals associated with inclisiran: a post-marketing analysis based on FAERS.

Background: This study analyzed adverse events (AEs) associated with inclisiran using the FDA's Adverse Event Reporting System (FAERS) to detect and characterize relevant safety signals.

Methods: We retrospectively extracted AE reports from the FAERS database spanning Q1 2022 to Q2 2024. Four disproportionality analysis algorithms were employed to identify AE signals for inclisiran, with subsequent comparisons made to PCSK9 monoclonal antibodies (alirocumab/evolocumab). Additionally, we examined the characteristics and onset timing of inclisiran-related AE.

Results: A total of 4,122 reports of inclisiran as the 'primary suspected'. Compared with all other drugs, the most significant system organ class (SOC) was 'musculoskeletal and connective tissue disorders' (ROR = 3.64, PRR = 3.19) and the most common SOC was 'general disorders and administration site conditions' (n = 2,769). These two SOCs were more strongly with inclisiran than evolocumab. At the preferred term level, strong signals were detected for cellulitis gangrenous (ROR = 101.29, PRR = 101.27, IC = 6.54, EBGM = 92.91) and bladder discomfort (ROR = 12.61, PRR = 12.61, IC = 3.64, EBGM = 12.48). The median onset time for inclisiran-related AEs was 43 days (interquartile range: 7-99 days).

Conclusions: This study enhanced our understanding of AEs to inclisiran. Future research on its long-term real-world use will offer insights into its safety.

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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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