A real-world pharmacovigilance study of QT interval prolongation and Torsades de Pointes associated with CDK4/6 inhibitors in breast cancer patients: findings from the FDA adverse event reporting system.

Autor:	Yan Y; 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., Wu B; Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China., Wang L; 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.
Jazyk:	angličtina
Zdroj:	Expert opinion on drug safety [Expert Opin Drug Saf] 2024 Sep; Vol. 23 (9), pp. 1191-1198. Date of Electronic Publication: 2024 Mar 14.
DOI:	10.1080/14740338.2024.2307375
Abstrakt:	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.
Databáze:	MEDLINE
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