Abstract
Background
Palbociclib and abemaciclib are cyclin-dependent kinase (CDK) 4/6 inhibitors currently used to treat breast cancer. Although their therapeutic efficacies are considered comparable, differences in adverse event (AE) profiles of the two drugs remain unclear.
Aim
We analysed two real-world databases, the World Health Organization’s VigiBase and the Food and Drug Administration Adverse Event Reporting System (FAERS), to identify differences in AE profiles of palbociclib and abemaciclib.
Method
Data of patients with breast cancer receiving palbociclib or abemaciclib recorded until December 2022 were extracted from the VigiBase and FAERS databases. In total, 200 types of AEs were analysed. The reporting odds ratios were calculated using a disproportionality analysis.
Results
Cytopenia was frequently reported in patients receiving palbociclib, whereas interstitial lung disease and diarrhoea were frequently reported in those receiving abemaciclib. Moreover, psychiatric and nervous system disorders were more common in the palbociclib group, whereas renal and urinary disorders were more common in the abemaciclib group.
Conclusion
This study is the first to show comprehensively the disparities in the AE profiles of palbociclib and abemaciclib. The findings highlight the importance of considering these differences when selecting a suitable CDK4/6 inhibitor to ensure safe and favourable outcomes for patients with breast cancer.
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Acknowledgements
We would like to thank Editage (www.editage.jp) for English editing and Mr. Tohta Mizushima (Department of Medicinal Pharmacology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan) for verifying the reproducibility of the data.
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No funding was received for conducting this study.
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Takeda, T., Sugimoto, S., Matsumoto, J. et al. A comparison between the adverse event profiles of patients receiving palbociclib and abemaciclib: analysis of two real-world databases. Int J Clin Pharm 46, 536–541 (2024). https://doi.org/10.1007/s11096-023-01687-6
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DOI: https://doi.org/10.1007/s11096-023-01687-6