| アブストラクト | BackgroundAbemaciclib, 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.MethodsAbemaciclib-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.ResultsWe 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.ConclusionThis 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. |
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| ジャーナル名 | The Journal of international medical research |
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| Pubmed追加日 | 2025/3/21 |
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| 投稿者 | Xu, Xiangchun; Guo, Xuzheng; Chen, Jinhui; Pan, Yuhua; Li, Jing; Chen, Jing; Lai, Weihua; Lin, Lu |
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| 組織名 | Department of Pharmacy, Guangdong Provincial People's Hospital (Guangdong Academy;of Medical Sciences), Southern Medical University, Guangzhou, China.;Department of Pharmacy, Xiangtan Traditional Chinese Medicine Hospital, Xiangtan,;Hunan, China.;Medical Research Institute, Guangdong Provincial Key Laboratory of South China;Structural Heart Disease, Guangdong Provincial People's Hospital (Guangdong;Academy of Medical Sciences), Southern Medical University, Guangzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40116800/ |
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