抗焦虑药物与 Torsade de Pointes 的关系:食品药品管理局不良事件报告系统的药物警戒研究。

IF 3.3 Q1 HEALTH POLICY & SERVICES Journal of Pharmaceutical Policy and Practice Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI:10.1080/20523211.2024.2399716
Zahid Ali, Mohammad Ismail, Inayat Ur Rehman, Khang Wen Goh, Pakhrur Razi, Long Chiau Ming
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引用次数: 0

摘要

背景:本研究旨在确定Torsade de Pointes (TdP)与抗焦虑药物的关联性,并详细概述向食品药品管理局不良事件报告系统(FAERS)报告的抗焦虑药物诱发TdP病例:方法:使用首选术语 "Torsade de Pointes,代码:10044066 "从FAERS数据库中检索了1990年至2020年间所有抗焦虑药诱发的TdP病例(n = 260):从《监管活动医学词典》(MedDRA,第 22 版)中选取了 "Torsade de Pointes,代码:10044066"。四种数据挖掘算法用于比例失调分析:报告比值比 (ROR)、比例报告比 (PRR)、经验贝叶斯几何平均数 (EBGM) 和信息含量 (IC)。结果:在总共 8 种药物中,本研究发现了 7 种 TdP 信号,其中 6 种是新信号,即阿普唑仑、溴西泮、劳拉西泮、甲丙氨酯、咪达唑仑和奥沙西泮。根据比例失调分析,在新信号中,溴西泮和米达唑仑的 TdP 风险最高。阿普唑仑的 TdP 风险最低,而地西泮没有达到显著的不相称性:本研究在抗焦虑药物中发现了六种新的 TdP 信号,因此需要进行严格的临床研究,以确定 TdP 的实际风险,确保患者安全:本研究已在 ClinicalTrials.gov 注册(NCT.gov ID:NCT04293432)。
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Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System.

Background: This study aimed to determine the association of Torsade de Pointes (TdP) with anxiolytic drugs and present a detailed overview of anxiolytic-induced cases of TdP reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: All cases of anxiolytic-induced TdP (n = 260) between 1990 and 2020 were retrieved from the FAERS database using the Preferred Term 'Torsade de Pointes, code: 10044066' from the Medical Dictionary for Regulatory Activities (MedDRA version 22). Four data-mining algorithms were used for disproportionality analysis: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Information Content (IC). Anxiolytics with ≥3 TdP cases were included.

Results: Of a total of eight drugs, this study identified seven signals of TdP, of which six signals were new, namely for alprazolam, bromazepam, lorazepam, meprobamate, midazolam, and oxazepam. Based on disproportionality analysis, among new signals, the highest risk of TdP was observed with bromazepam and midazolam. Alprazolam showed the lowest risk for TdP, while diazepam did not reach significant disproportionality.

Conclusions: This study identified six new signals of TdP among anxiolytic drugs, so warranting stringent clinical studies to ascertain the actual risk of TdP and ensure patient safety.

Clinical trial registration: This study is registered at ClinicalTrials.gov (NCT.gov ID: NCT04293432).

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来源期刊
Journal of Pharmaceutical Policy and Practice
Journal of Pharmaceutical Policy and Practice Health Professions-Pharmacy
CiteScore
4.70
自引率
9.50%
发文量
81
审稿时长
14 weeks
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