Wu Ziyang, Zhou Pengxiang, He Na, Zhai Suodi
Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
Front Cardiovasc Med. 2022 Oct 24;9:966331. doi: 10.3389/fcvm.2022.966331. eCollection 2022.
This study aimed to identify the most common and top drugs associated with the risk of torsades de pointes (TdP) based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.
We used OpenVigil 2.1 to query FAERS database and data from the first quarter of 2004 to the third quarter of 2021 were retrieved. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify TdP cases. We listed the most common drugs associated with the reported TdP cases. Then, the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) for the reporting association between different drugs and TdP risk were calculated. Meanwhile, comparisons were conducted with the QT drug lists of CredibleMeds in an attempt to identify drugs with a potential risk of TdP that were not on the list.
A total of 9,217,181 adverse event reports were identified, of which 3,807 (0.04%) were related to TdP. TdP was more likely to occur in the elderly and females. Amiodarone (464 cases) was associated with most cases of TdP. According to the disproportionality analysis, the top five drugs with the highest ROR and PRR were tolazoline (ROR 1615.11, 95% confidence interval [CI] 455.59-5725.75, PRR 969.46, χ 2960.10), levomethadyl (ROR 1211.01, 95% CI 302.75-4844.04, PRR 807.67, χ 1677.03), ibutilide (ROR 1118.74, 95% CI 425.00-2944.91, PRR 765.77, χ 3845.27), halofantrine (ROR 660.55, 95% CI 184.21-2368.69, PRR 519.22, χ 1076.31), and isoproterenol (ROR 352.20, 95% CI 227.19-546.00, PRR 307.82, χ 6692.53). Approximately half of the top 50 drugs (22 for ROR, 30 for PRR) were not outlined on the QT drug lists of CredibleMeds.
Approximately half of the top risk drugs (22 for ROR, 30 for PRR) were not outlined in the QT drug lists of CredibleMeds. Notably, potential risks are of great importance and should be closely monitored in clinical practice. Also, further research is needed to investigate the association between these drugs and TdP.
本研究旨在基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库，确定与尖端扭转型室速（TdP）风险相关的最常见及排名靠前的药物。
我们使用OpenVigil 2.1查询FAERS数据库，并检索了2004年第一季度至2021年第三季度的数据。使用《药物监管活动医学词典》（MedDRA）来识别TdP病例。我们列出了与报告的TdP病例相关的最常见药物。然后，计算不同药物与TdP风险之间报告关联的报告比值比（ROR）和比例报告比值（PRR）。同时，与CredibleMeds的QT药物列表进行比较，以试图识别未在该列表上但具有TdP潜在风险的药物。
共识别出9217181份不良事件报告，其中3807份（0.04%）与TdP相关。TdP更易发生于老年人和女性。胺碘酮（464例）与大多数TdP病例相关。根据不成比例分析，ROR和PRR最高的前五种药物为妥拉唑啉（ROR 1615.11，95%置信区间[CI] 455.59 - 5725.75，PRR 969.46，χ² 960.10）、左美沙酮（ROR 1211.01，95% CI 302.75 - 4844.04，PRR 807.67，χ² 1677.03）、伊布利特（ROR 1118.74，95% CI 425.00 - 2944.91，PRR 765.77，χ² 3845.27）、卤泛群（ROR 660.55，95% CI 184.21 - 2368.69，PRR 519.22，χ² 1076.31）和异丙肾上腺素（ROR 352.20，95% CI 227.19 - 546.00，PRR 307.82，χ² 6692.53）。前50种药物中约一半（ROR方面22种，PRR方面30种）未在CredibleMeds的QT药物列表中列出。
前50种风险最高的药物中约一半（ROR方面22种，PRR方面30种）未在CredibleMeds的QT药物列表中列出。值得注意的是，潜在风险非常重要，在临床实践中应密切监测。此外，需要进一步研究来调查这些药物与TdP之间的关联。
