A real-world pharmacovigilance study of drug-induced QT interval prolongation: analysis of spontaneous reports submitted to FAERS

作者全名：Tan, Haowen; Yan, Xida; Chen, Ying; Huang, Guili; Luo, Luping; Li, Wenjun; Lan, Weiwei; Chen, Cheng; Xi, Xin

作者地址：[Tan, Haowen; Luo, Luping; Lan, Weiwei] Wuzhou Red Cross Hosp, Dept Pharm, Wuzhou, Guangxi, Peoples R China; [Tan, Haowen; Chen, Ying] Wuzhou Red Cross Hosp, Off Good Clin Practice, Wuzhou, Guangxi, Peoples R China; [Yan, Xida] Mianyang Cent Hosp, Dept Pharm, Mianyang, Sichuan, Peoples R China; [Huang, Guili; Li, Wenjun; Chen, Cheng; Xi, Xin] Chongqing Med Univ, Affiliated Hosp 3, Dept Pharm, Chongqing, Peoples R China

通信作者：Xi, X (通讯作者)，Chongqing Med Univ, Affiliated Hosp 3, Dept Pharm, Chongqing, Peoples R China.

来源：FRONTIERS IN CARDIOVASCULAR MEDICINE

ESI学科分类：　

WOS号：WOS:001230886500001

JCR分区：Q2

影响因子：2.8

年份：2024

卷号：11

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：QT interval prolongation; pharmacovigilance; FAERS; data mining; reporting odds ratio

摘要：Purpose To identify the most commonly reported drugs associated with QT interval prolongation in the FDA Adverse Event Reporting System (FAERS) and evaluate their risk for QT interval prolongation.Methods We employed the preferred term (PT) "electrocardiogram QT prolonged" from the Medical Dictionary for Regulatory Activities (MedDRA) 26.0 to identify adverse drug events (ADEs) of QT interval prolongation in the FAERS database from the period 2004-2022. Reporting odds ratio (ROR) was performed to quantify the signals of ADEs.Results We listed the top 40 drugs that caused QT interval prolongation. Among them, the 3 drugs with the highest number of cases were quetiapine (1,151 cases, ROR = 7.62), olanzapine (754 cases, ROR = 7.92), and citalopram (720 cases, ROR = 13.63). The two most frequently reported first-level Anatomical Therapeutic Chemical (ATC) groups were the drugs for the nervous system (n = 19, 47.50%) and antiinfectives for systemic use (n = 7, 17.50%). Patients with missing gender (n = 3,482, 23.68%) aside, there were more females (7,536, 51.24%) than males (5,158, 35.07%) were involved. 3,720 patients (25.29%) suffered serious clinical outcomes resulting in deaths or life-threatening conditions. Overall, most drugs that caused QT interval prolongation had early failure types according to the assessment of the Weibull's shape parameter (WSP) analysis.Conclusions Our study offered a list of drugs that frequently caused QT interval prolongation based on the FAERS system, along with a description of some risk profiles for QT interval prolongation brought on by these drugs. When prescribing these drugs in clinical practice, we should closely monitor the occurrence of ADE for QT interval prolongation.

基金机构：Third Affiliated Hospital of Chongqing Medical University, China

基金资助正文：The FAERS database, which was made available by the FDA, was used to conduct this study. The FDA does not have any opinion about the data, findings, or interpretation of the current study.