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
机构：[1]Capital Med Univ, Beijing Tongren Hosp, Dept Geriatr, Beijing, Peoples R China临床科室老年医学科/干部医疗科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[2]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Natl Canc Ctr,Dept Pharm, Beijing, Peoples R China[3]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Natl Canc Ctr,Dept Comprehens Oncol, Beijing, Peoples R China
BackgroundSelective 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 methodsData 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.ResultsBoth 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.ConclusionsSelective 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.
基金：
CAMS Innovation Fund for Medical Sciences (CIFMS) - Special Research Fund for Central Universities, Peking Union Medical College [2022-I2M-CT-B-069]; Program of Beijing Hope Run Special Fund of Cancer Foundation of China [LC2020A17]
第一作者机构：[1]Capital Med Univ, Beijing Tongren Hosp, Dept Geriatr, Beijing, Peoples R China
共同第一作者：
通讯作者：
通讯机构：[3]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Natl Canc Ctr,Dept Comprehens Oncol, Beijing, Peoples R China[*1]Chinese Acad Med Sci, Canc Hosp, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China
推荐引用方式(GB/T 7714)：
Hou Yinjing,Ren Xiayang,Chen Ying,et al.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[J].EXPERT OPINION ON DRUG SAFETY.2024,doi:10.1080/14740338.2024.2392003.
APA：
Hou, Yinjing,Ren, Xiayang,Chen, Ying&Wang, Yanfeng.(2024).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.EXPERT OPINION ON DRUG SAFETY,,
MLA：
Hou, Yinjing,et al."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".EXPERT OPINION ON DRUG SAFETY .(2024)
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