Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry, Department of Clinical Pharmacy and Pharmacy Administration, West China School of Pharmacy, Sichuan University, Chengdu, China.
Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Expert Opin Drug Saf. 2024 Sep;23(9):1191-1198. doi: 10.1080/14740338.2024.2307375. Epub 2024 Mar 14.
The aim of this study was to evaluate the association between CDK4/6 inhibitors and QT interval prolongation (QTp) and Torsades de Pointes (TdP) in breast cancer patients.
The cases with breast cancer from 2015 to 2022 were extracted from the FDA adverse event database (FARES) and further divided into a CDK4/6 inhibitor group and a positive control group. The associations between CDK4/6 inhibitors and QTp and TdP adverse events were evaluated using the reporting odds ratio (ROR) and the information component (IC).
A total of 172,266 breast cancer patients were included. A total of 234 QTp/TdP events occurred in the CDK4/6 inhibitor group. Disproportionality analysis revealed that ribociclib was related to QTp/TdP. The ROR was 10.10 (95% 8.56-11.92), and the IC was 2.84 (95% 2.28-3.32). Palbociclib and abemaciclib had no correlation with QTP/TDP events.
Based on this real-world pharmacovigilance analysis, this study demonstrated a significant association between ribociclib and QTp/TdP events, which should attract clinical attention. The QT interval was monitored before and after medication. Attention should be given to adjusting the drugson time.
本研究旨在评估 CDK4/6 抑制剂与乳腺癌患者 QT 间期延长（QTp）和尖端扭转型室性心动过速（TdP）的相关性。
从 FDA 不良事件数据库（FARES）中提取 2015 年至 2022 年的乳腺癌病例，并进一步分为 CDK4/6 抑制剂组和阳性对照组。使用报告比值比（ROR）和信息成分（IC）评估 CDK4/6 抑制剂与 QTp 和 TdP 不良事件的相关性。
共纳入 172266 例乳腺癌患者。在 CDK4/6 抑制剂组共发生 234 例 QTp/TdP 事件。不均衡性分析显示，瑞博西利与 QTp/TdP 相关。ROR 为 10.10（95%置信区间 8.56-11.92），IC 为 2.84（95%置信区间 2.28-3.32）。帕博西利和阿贝西利与 QTP/TDP 事件无相关性。
基于这项真实世界的药物警戒分析，本研究表明瑞博西利与 QTp/TdP 事件之间存在显著相关性，这应引起临床关注。在用药前后监测 QT 间期。应注意及时调整药物。
