PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■确定FDA不良事件报告系统（FAERS）中最常见的与QT间期延长相关的药物，并评估其QT间期延长的风险。
■我们使用了来自监管活动医学词典（MedDRA）26.0的首选术语（PT）“心电图QT延长”，以识别2004-2022年FAERS数据库中QT间期延长的不良药物事件（ADE）。进行报告比值比（ROR）以量化ADE的信号。
■我们列出了导致QT间期延长的前40种药物。其中,病例数最高的3种药物是喹硫平(1151例,ROR=7.62),奥氮平(754例，ROR=7.92),和西酞普兰(720例，ROR=13.63)。两个最常报告的一级解剖治疗化学（ATC）组是神经系统药物（n=19，47.50％）和全身使用的抗感染药（n=7，17.50％）。除性别缺失患者外（n=3,482，23.68％），女性(7,536,51.24%)多于男性(5,158,35.07%)。3,720名患者（25.29％）遭受了严重的临床结果，导致死亡或危及生命的状况。总的来说,根据Weibull形状参数(WSP)分析的评估,大多数导致QT间期延长的药物具有早期失效类型.
■我们的研究提供了一系列基于FAERS系统的经常引起QT间期延长的药物，以及这些药物引起的QT间期延长的一些风险特征的描述。在临床实践中开出这些药物时，应密切监测ADE对QT间期延长的发生。
■我们使用了来自监管活动医学词典（MedDRA）26.0的首选术语（PT）“心电图QT延长”，以识别2004-2022年FAERS数据库中QT间期延长的不良药物事件（ADE）。进行报告比值比（ROR）以量化ADE的信号。
■我们列出了导致QT间期延长的前40种药物。其中,病例数最高的3种药物是喹硫平(1151例,ROR=7.62),奥氮平(754例，ROR=7.92),和西酞普兰(720例，ROR=13.63)。两个最常报告的一级解剖治疗化学（ATC）组是神经系统药物（n=19，47.50％）和全身使用的抗感染药（n=7，17.50％）。除性别缺失患者外（n=3,482，23.68％），女性(7,536,51.24%)多于男性(5,158,35.07%)。3,720名患者（25.29％）遭受了严重的临床结果，导致死亡或危及生命的状况。总的来说,根据Weibull形状参数(WSP)分析的评估,大多数导致QT间期延长的药物具有早期失效类型.
■我们的研究提供了一系列基于FAERS系统的经常引起QT间期延长的药物，以及这些药物引起的QT间期延长的一些风险特征的描述。在临床实践中开出这些药物时，应密切监测ADE对QT间期延长的发生。
