| アブストラクト | BACKGROUND: The aim of this study was to evaluate the association between CDK4/6 inhibitors and QT interval prolongation (QTp) and Torsades de Pointes (TdP) in breast cancer patients. METHOD: The cases with breast cancer from 2015 to 2022 were extracted from the FDA adverse event database (FARES) and further divided into a CDK4/6 inhibitor group and a positive control group. The associations between CDK4/6 inhibitors and QTp and TdP adverse events were evaluated using the reporting odds ratio (ROR) and the information component (IC). RESULTS: A total of 172,266 breast cancer patients were included. A total of 234 QTp/TdP events occurred in the CDK4/6 inhibitor group. Disproportionality analysis revealed that ribociclib was related to QTp/TdP. The ROR was 10.10 (95% 8.56-11.92), and the IC was 2.84 (95% 2.28-3.32). Palbociclib and abemaciclib had no correlation with QTP/TDP events. CONCLUSION: Based on this real-world pharmacovigilance analysis, this study demonstrated a significant association between ribociclib and QTp/TdP events, which should attract clinical attention. The QT interval was monitored before and after medication. Attention should be given to adjusting the drugson time. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/3/14 |
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| 投稿者 | Yan, Yu; Wu, Bin; Wang, Ling |
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| 組織名 | Key Laboratory of Drug-Targeting and Drug Delivery System of the Education;Ministry, Department of Clinical Pharmacy and Pharmacy Administration, West China;School of Pharmacy, Sichuan University, Chengdu, China.;Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38482864/ |
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