| アブストラクト | We analyzed thromboembolic events, recognized (AESIs), with cyclin-dependent kinase (CDK)4/6 inhibitors, using the Food and Drug Administration adverse event reporting system. METHODS: Thromboembolic events were characterized in terms of spectrum [venous and arterial thromboembolism (VTE; ATE)] and clinical features by combining the disproportionality approach [reporting odds ratio (ROR) with 95% confidence interval (CI)] with individual case assessment. RESULTS: A total of 1722 thromboembolic events were retained. Increased VTE reporting emerged for CDK4/6 inhibitors in the exploratory analyses (n = 659; ROR = 1.51; 95% CI = 1.39-1.63), with consistent disproportionality in the consolidated analyses (e.g., deep vein thrombosis with abemaciclib: 17; 1.98; 1.22-3.19). Higher-than-expected ATE reporting was found for ribociclib, including myocardial infarction (41; 1.82; 1.33-2.48), with rapid onset (median latency 1 vs. 6 months for other CDK4/6 inhibitors). Causality was highly probable or probable in 83.2% of cases, with a negligible proportion of pre-existing drug- and patient-related risk factors except for cardiovascular comorbidities (26%). CONCLUSIONS: Although causal association cannot be firmly inferred, oncologists should proactively monitor the occurrence of VTE with CDK4/6 inhibitors. The unexpected distinctive increased ATE reporting with ribociclib deserves urgent clarification though large comparative population-based studies. We support pharmacovigilance for the post-marketing characterization of AESIs, thus promoting real-time safe prescribing in oncology. |
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| 投稿日 | 2021/5/1 |
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| 投稿者 | Raschi, Emanuel; Fusaroli, Michele; Ardizzoni, Andrea; Poluzzi, Elisabetta; De Ponti, Fabrizio |
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| ジャーナル名 | Cancers |
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| 組織名 | Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater;Studiorum-University of Bologna, 40126 Bologna, Italy.;Medical Oncology Unit, Department of Experimental, Diagnostic and Specialty;Medicine, Policlinico S. Orsola-Malpighi, Alma Mater Studiorum-University of;Bologna, 40126 Bologna, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33917020/ |
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