Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. data

医学 帕博西利布 不利影响 药物警戒 优势比 内科学 细胞周期蛋白依赖激酶 不良事件报告系统 静脉血栓栓塞 肿瘤科 癌症 乳腺癌 转移性乳腺癌 细胞周期 血栓形成
作者
Ming‐Ming Yan,Shu-Shan Wu,Yu-Peng Qi,Ziran Li,Qian Zhang,Hui Zhao,Mingkang Zhong,Xiaoyan Qiu
出处
期刊:Expert Opinion on Drug Safety [Taylor & Francis]
卷期号:21 (2): 277-283 被引量:9
标识
DOI:10.1080/14740338.2021.1981856
摘要

Real world studies have started to emerged on occurrence of venous thromboembolism (VTE) with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, but still deserve constant surveillance and evaluation. This study was to analyze this association.Adverse event cases were acquired from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database betweenJanuary 1st 2015 and December 31st 2020.Signals indicating association between CDK 4/6 inhibitors and VTE were identified by reporting odds ratio (ROR). CDK 4/6 inhibitors had a total of 631 reports of VTE (ROR 1.44, 95% CI 1.33-1.55) compared with non-CDK 4/6 inhibitors. Palbociclib (ROR 1.42, 95% CI 1.09-1.88) demonstratedthe highest number of VTE reports, followed by ribociclib (ROR 1.41, 95% CI 1.29-1.54) and abemaciclib (ROR 0.92, 95% CI 0.72-1.17).Although it is not able to confirm the casual relationship between VTE and CDK4/6 inhibitors, this study suggested signal of VTE reporting in patients receiving CDK4/6 inhibitors, which is likely to reflect a potential association. The results may enhance physicians' awareness of the potential side effect of VTE associated with CDK 4/6 inhibitors. An early recognition of VTE signs/symptoms could decrease the morbidity and severity of such adverse events.
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