Drug-induced QT prolongation and torsade de pointes: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database

作者全名："Li, Dongxuan; Chai, Shuang; Wang, Hongli; Dong, Jie; Qin, Chunmeng; Du, Dan; Wang, Yalan; Du, Qian; Liu, Songqing"

作者地址："[Li, Dongxuan; Chai, Shuang; Dong, Jie; Qin, Chunmeng; Du, Dan; Wang, Yalan; Du, Qian; Liu, Songqing] Chongqing Med Univ, Dept Pharm, Affiliated Hosp 3, Chongqing, Peoples R China; [Wang, Hongli] Chongqing Med Univ, Dept Pharm, Affiliated Yongchuan Hosp, Chongqing, Peoples R China; [Qin, Chunmeng; Wang, Yalan] Chongqing Med Univ, Coll Pharm, Chongqing, Peoples R China"

通信作者："Du, Q; Liu, SQ (通讯作者)，Chongqing Med Univ, Dept Pharm, Affiliated Hosp 3, Chongqing, Peoples R China."

来源：FRONTIERS IN PHARMACOLOGY

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001135569300001

JCR分区：Q1

影响因子：4.4

年份：2023

卷号：14

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：QT prolongation; torsade de pointes; FDA adverse event reporting system; disproportionality analysis; pharmacovigilance; adverse reaction

摘要："Introduction: Drug-induced QT prolongation and (or) Torsade de Pointes (TdP) is a well-known serious adverse reaction (ADR) for some drugs, but the widely recognized comprehensive landscape of culprit-drug of QT prolongation and TdP is currently lacking.Aim: To identify the top drugs reported in association with QT prolongation and TdP and provide information for clinical practice.Method: We reviewed the reports related to QT prolongation and TdP in the FDA Adverse Event Reporting System (FAERS) database from January 1, 2004 to December 31, 2022, and summarized a potential causative drug list accordingly. Based on this drug list, the most frequently reported causative drugs and drug classes of QT prolongation and TdP were counted, and the disproportionality analysis for all the drugs was conducted to in detect ADR signal. Furthermore, according to the positive-negative distribution of ADR signal, we integrated the risk characteristic of QT prolongation and TdP in different drugs and drug class.Results: A total of 42,713 reports in FAERS database were considered to be associated with QT prolongation and TdP from 2004 to 2022, in which 1,088 drugs were reported as potential culprit-drugs, and the largest number of drugs belonged to antineoplastics. On the whole, furosemide was the most frequently reported drugs followed by acetylsalicylic acid, quetiapine, citalopram, metoprolol. In terms of drug classes, psycholeptics was the most frequently reported drug classes followed by psychoanaleptics, analgesics, beta blocking agents, drugs for acid related disorders. In disproportionality analysis, 612 drugs showed at least one positive ADR signals, while citalopram, ondansetron, escitalopram, loperamide, and promethazine were the drug with the maximum number of positive ADR signals. However, the positive-negative distribution of ADR signals between different drug classes showed great differences, representing the overall risk difference of different drug classes.Conclusion: Our study provided a real-world overview of QT prolongation and TdP to drugs, and the presentation of the potential culprit-drug list, the proportion of reports, the detection results of ADR signals, and the distribution characteristics of ADR signals may help understand the safety profile of drugs and optimize clinical practice."

基金机构：Research Incubation Project of The Third Affiliated Hospital of Chongqing Medical University [KY22038]; Education Reform Project of the Chongqing Municipal Education Commission [234035]

基金资助正文："The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This work was supported by the Research Incubation Project of The Third Affiliated Hospital of Chongqing Medical University (KY22038) and the Education Reform Project of the Chongqing Municipal Education Commission (234035)."