| アブストラクト | OBJECTIVES: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2021/9/29 |
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| 投稿者 | Yan, Ming-Ming; Wu, Shu-Shan; Qi, Yu-Peng; Li, Zi-Ran; Zhang, Qian; Zhao, Hui; Zhong, Ming-Kang; Qiu, Xiao-Yan |
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| 組織名 | Clinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai P. R.;China.;College of Pharmacy, University of Nebraska Medical Center, Omaha, NE. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34581647/ |
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