Why the study?
To analyze and characterize thromboembolic events, recognized as adverse events of special interest, associated with CDK4/6 inhibitors using post-marketing pharmacovigilance data.
Are CDK4/6 inhibitors associated with an increased reporting of thromboembolic events in the FDA adverse event reporting system?
Are CDK4/6 inhibitors associated with an increased reporting of thromboembolic events in the FDA adverse event reporting system?
CDK4/6 inhibitors are associated with increased reporting of thromboembolic events in the FDA adverse event database, particularly arterial events with ribociclib, highlighting the need for proactive cardiovascular monitoring in oncology patients.
May signal elevated thromboembolic risk with CDK4/6 inhibitors; hypothesis-generating and requires prospective confirmation.
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: = 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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Raschi et al. (2021) studied this question.
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