新型心血管药物 vericiguat 的不良事件评估:基于 FAERS 的真实世界药物警戒研究。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-07-19 DOI:10.1080/14740338.2024.2382226
Jin Rao, Xiangyu Chen, Yudi Liu, Xuefu Wang, Pengchao Cheng, Zhinong Wang
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引用次数: 0

摘要

研究背景本研究旨在利用美国食品和药物管理局不良事件报告系统(FAERS)的数据分析韦立克(vericiguat)的不良事件报告(AERs),并为临床应用提供证据:筛选了2021Q1至2024Q1期间被确定为主要疑似药物的韦立克AER,随后剔除了重复报告。然后采用各种定量信号检测方法,包括报告几率比(ROR)、比例报告比(PRR)、贝叶斯置信度传播神经网络和多项目伽马泊松收缩器,进行数据挖掘和分析。信号强度用 95% 置信区间、信息成分(IC)和经验贝叶斯几何平均数(EBGM)表示:结果:共发现了 617 个与 vericiguat 相关的 AER。在 21 个系统器官类别中观察到强烈信号。此外,最常报告的首选术语(PT)是低血压(n = 86,ROR 25.92,PRR 24.11,IC 4.59,EBGM 24.07),其次是头晕(n = 52,ROR 6.44,PRR 6.20,IC 2.63,EBGM 6.20)、乏力(n = 25,ROR 3.59,PRR 3.54,IC 1.82,EBGM 3.54)、血压下降(n = 23,ROR 20.00,PRR 19.64,IC 4.29,EBGM 19.61)和贫血(n = 21,ROR 6.67,PRR 6.57,IC 2.72,EBGM 6.57):本研究扩展了 FDA 说明书中记录的不良反应,为 vericiguat 的临床安全性提供了补充证据。
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Assessment of adverse events of the novel cardiovascular drug vericiguat: a real-world pharmacovigilance study based on FAERS.

Background: This study aims to analyze the adverse event reports (AERs) to vericiguat using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) and provide evidence for the clinical use.

Methods: AERs due to vericiguat from 2021Q1 to 2024Q1 identified as the primary suspect were screened, with duplicate reports subsequently eliminated. Various quantitative signal detection methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, were then employed for data mining and analysis. Signal strength is represented by the 95% confidence interval, information component (IC), and empirical Bayesian geometric mean (EBGM).

Results: A total of 617 vericiguat-related AERs were identified. Strong signals were observed in 21 system organ classes. Furthermore, the most frequently reported preferred terms (PT) was hypotension (n = 86, ROR 25.92, PRR 24.11, IC 4.59, EBGM 24.07), followed by dizziness (n = 52, ROR 6.44, PRR 6.20, IC 2.63, EBGM 6.20), malaise (n = 25, ROR 3.59, PRR 3.54, IC 1.82, EBGM 3.54), blood pressure decreased (n = 23, ROR 20.00, PRR 19.64, IC 4.29, EBGM 19.61), and anemia (n = 21, ROR 6.67, PRR 6.57, IC 2.72, EBGM 6.57).

Conclusions: This study extended the adverse reactions documented in the FDA instruction and provided supplementary evidence regarding the clinical safety of vericiguat.

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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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