摘要
Abstract
Objective To explore and evaluate the association between cyclin-dependent kinase 4/6(CDK4/6)inhibitors and thromboembolic events,so as to provide reference for clinical safety of drug use.Methods Using the OpenVigil 2.1 pharmacovigilance analysis tool,thromboembolic events related to CDK4/6 inhibitors in the US Food and Drug Administration's Adverse Event Reporting System(FAERS)database were extracted.The extraction period ended on December 31,2024.Signal analysis of thromboembolic events was conducted using the report odds ratio method(ROR)and the proportion report ratio method(PRR).Results A total of 1516 thromboembolic events related to CDK4/6 inhibitors were retrieved,of which 984,228,304 were identified by palbociclib,abemaciclib and ribociclib,respectively.Pulmonary embolic events were the most common,accounting for 59.83%(907/1516)of all thromboembolic events.37.34%(566/1516)of CDK4/6 inhibitor-related thromboembolism events occurred in 18-64 years of age,45.78%(694/1516)in 65-85 years of age.In terms of gender composition,women are higher than men.The signal results showed that pulmonary embolism produced suspicious signals in all three CDK4/6 inhibitors,and the intensity was ranked as abemaciclib＞ribociclib＞palbociclib.Conclusion This study identified a significant association between all three CDK4/6 inhibitors(palbociclib,abemaciclib,and ribociclib)and thromboembolic events.Clinicians should implement rigorous monitoring protocols to mitigate the risk of thromboembolic ADEs.关键词
细胞周期蛋白依赖性激酶4/6抑制剂/血栓栓塞/不良反应/信号挖掘Key words
Cyclin-dependent kinase 4/6 inhibitors/Thromboembolism/Adverse reactions/Signal mining分类
医药卫生
