Cardiovascular toxicities of selective ret-specific tyrosine kinase inhibitors: a pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database.

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Cardiovascular toxicities of selective ret-specific tyrosine kinase inhibitors: a pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database.

Cardiovascular toxicities of selective ret-specific tyrosine kinase inhibitors: a pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database.

アブストラクト	BACKGROUND: Selective RET-specific tyrosine kinase inhibitors (RET-TKIs) treat RET fusion-positive non-small cell lung cancer (NSCLC), but studies on their cardiovascular toxicities are limited. This study aimed to characterize the cardiovascular toxicities associated with selective RET-TKI in real-world settings. RESEARCH DESIGN AND METHODS: Data from the United States Food and Drug Administration Adverse Event Reporting System database from 1 January 2020 to 30 June 2023, were analyzed. Two disproportionality methods, information component and reporting odds ratio (ROR) were used. RESULTS: Both pralsetinib and selpercatinib showed positive signals for hypertension (pralsetinib: ROR: 5.25, 95% CI: 4.40-6.26; selpercatinib: ROR: 2.68, 95% CI: 1.87-3.82). Additionally, pralsetinib showed a positive signal for ischemic heart disease ( ROR: 3.92, 95% CI: 2.94-5.23), and selpercatinib for torsade de pointes/QT prolongation ( ROR: 2.65, 95% CI: 1.74-4.04). The median time to onset(TTO) of cardiovascular toxicities was 33 days (IQR: 9-73 days) for pralsetinib and 15 days (IQR: 10-50 days) for selpercatinib. The proportion of deaths, life-threatening events, and hospitalizations due to cardiovascular toxicities were 8.57%, 1.19%, and 31.43%, respectively, for total selective RET-TKI. CONCLUSIONS: Selective RET-TKIs are related to multiple cardiovascular toxicities. Pralsetinib was linked to ischemic heart disease, and selpercatinib to torsade de pointes/QT prolongation and thrombotic events.
ジャーナル名	Expert opinion on drug safety
Pubmed追加日	2024/8/14
投稿者	Hou, Yinjing; Ren, Xiayang; Chen, Ying; Wang, Yanfeng
組織名	Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University,;Beijing, China.;Department of Pharmacy, National Cancer Center/National Clinical Research Center;for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union;Medical College, Beijing, China.;Department of Comprehensive Oncology, National Cancer Center/National Clinical;Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences;and Peking Union Medical College, Beijing, China.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/39137926/