Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system
Background Abemaciclib, an oral kinase inhibitor, is used to treat hormone receptor–positive and HER2-negative breast cancer patients. However, there has been a decrease in studies reporting adverse reactions to abemaciclib-related kidney injuries. Thus, this study was aimed at assessing its safety...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2025-03-01
|
| Series: | Journal of International Medical Research |
| Online Access: | https://doi.org/10.1177/03000605251325961 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850201277621862400 |
|---|---|
| author | Xiangchun Xu Xuzheng Guo Jinhui Chen Yuhua Pan Jing Li Jing Chen Weihua Lai Lu Lin |
| author_facet | Xiangchun Xu Xuzheng Guo Jinhui Chen Yuhua Pan Jing Li Jing Chen Weihua Lai Lu Lin |
| author_sort | Xiangchun Xu |
| collection | DOAJ |
| description | Background Abemaciclib, an oral kinase inhibitor, is used to treat hormone receptor–positive and HER2-negative breast cancer patients. However, there has been a decrease in studies reporting adverse reactions to abemaciclib-related kidney injuries. Thus, this study was aimed at assessing its safety profile using a large-scale pharmacovigilance database. Methods Abemaciclib-related adverse drug reaction reports from the Food and Drug Administration Adverse Event Reporting System were obtained and scrutinized, and adverse drug reactions were selected using reporting odds ratio, the proportional reporting ratio methods, empirical Bayes geometric mean and UK Medicines and Healthcare products Regulatory Agency methods. Results We selected 10,757 matched reports associated with abemaciclib, among which we found eight adverse reactions about kidney injuries correlated with abeamciclib, such as increased blood creatinine, renal disorder, decreased glomerular filtration rate, increased blood urea, hydronephrosis, abnormal renal function test, increased creatinine renal clearance and increased cystatin C. A demographic analysis of reported cases of abemaciclib-associated renal injury revealed that the majority were female, aged ≥46 years and had taken the drug ≥30 days. Conclusion This study highlights the characteristics of adverse reactions with abemaciclib and those associated with renal damage, which are crucial for safety studies on the clinical use of this drug. |
| format | Article |
| id | doaj-art-e22b50c471fd40b8998b0df067f4d0a9 |
| institution | OA Journals |
| issn | 1473-2300 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Journal of International Medical Research |
| spelling | doaj-art-e22b50c471fd40b8998b0df067f4d0a92025-08-20T02:12:03ZengSAGE PublishingJournal of International Medical Research1473-23002025-03-015310.1177/03000605251325961Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting systemXiangchun XuXuzheng GuoJinhui ChenYuhua PanJing LiJing ChenWeihua LaiLu LinBackground Abemaciclib, an oral kinase inhibitor, is used to treat hormone receptor–positive and HER2-negative breast cancer patients. However, there has been a decrease in studies reporting adverse reactions to abemaciclib-related kidney injuries. Thus, this study was aimed at assessing its safety profile using a large-scale pharmacovigilance database. Methods Abemaciclib-related adverse drug reaction reports from the Food and Drug Administration Adverse Event Reporting System were obtained and scrutinized, and adverse drug reactions were selected using reporting odds ratio, the proportional reporting ratio methods, empirical Bayes geometric mean and UK Medicines and Healthcare products Regulatory Agency methods. Results We selected 10,757 matched reports associated with abemaciclib, among which we found eight adverse reactions about kidney injuries correlated with abeamciclib, such as increased blood creatinine, renal disorder, decreased glomerular filtration rate, increased blood urea, hydronephrosis, abnormal renal function test, increased creatinine renal clearance and increased cystatin C. A demographic analysis of reported cases of abemaciclib-associated renal injury revealed that the majority were female, aged ≥46 years and had taken the drug ≥30 days. Conclusion This study highlights the characteristics of adverse reactions with abemaciclib and those associated with renal damage, which are crucial for safety studies on the clinical use of this drug.https://doi.org/10.1177/03000605251325961 |
| spellingShingle | Xiangchun Xu Xuzheng Guo Jinhui Chen Yuhua Pan Jing Li Jing Chen Weihua Lai Lu Lin Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system Journal of International Medical Research |
| title | Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system |
| title_full | Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system |
| title_fullStr | Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system |
| title_full_unstemmed | Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system |
| title_short | Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system |
| title_sort | abemaciclib associated kidney injuries a retrospective analysis of the united states food and drug administration adverse events reporting system |
| url | https://doi.org/10.1177/03000605251325961 |
| work_keys_str_mv | AT xiangchunxu abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem AT xuzhengguo abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem AT jinhuichen abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem AT yuhuapan abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem AT jingli abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem AT jingchen abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem AT weihualai abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem AT lulin abemaciclibassociatedkidneyinjuriesaretrospectiveanalysisoftheunitedstatesfoodanddrugadministrationadverseeventsreportingsystem |