Data mining for hypertension associated with VEGFR-TKIs: based on FAERS database

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Author: Xiao-Lan LIAO ¹ Jia-Qi GE ² Hai-Bin ZHU ¹ Ting-Ting WU ¹ Chun-Xia REN ¹  Zi-Cheng YU ¹

Affiliation: 1. Department of Pharmacy, Yangpu Hospital, Tongji University, Shanghai 200090, China 2. School of Medicine and Pharmacy, Ocean University of China, Qingdao 266003, Shandong Province, China

Keywords: Vascular endothelial growth factor receptor-tyrosine kinase inhibitors Hypertension Adverse drug events Pharmacovigilance FAERS database

DOI: 10.19960/j.issn.1005-0698.202311001

Reference: Xiao-Lan LIAO, Jia-Qi GE, Hai-Bin ZHU, Ting-Ting WU, Chun-Xia REN, Zi-Cheng YU.Data mining for hypertension associated with VEGFR-TKIs: based on FAERS database[J].Yaowu Liuxingbingxue Zazhi,2023, 32(11): 1201-1208.DOI: 10.19960/j.issn.1005-0698.202311001.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To analyze the characteristics of hypertension adverse event (AE) associated with vascular endothelial growth factor receptor (VEGFR) - tyrosine kinase inhibitors (TKIs) and compare the hypertension AE signals and onset time among different VEGFR-TKIs.

Methods A retrospective analysis of VEGFR-TKIs-associated hypertension AE reports in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the fourth quarter of 2020 was performed to detect the AE signs of VEGFR-TKIs-associated hypertension by the reporting odds ratio (ROR) method, composite criteria method of Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and information component (IC) method, and the data were managed and visualized by using MySQL Workbench and R software, while information about the data such as clinical features was analyzed.

Results A total of 11 488 AE reports of hypertension associated with 9 VEGFR-TKIs as the primary suspected drugs were detected. The proportion of patients over 65 years old (43.11%) and the proportion of hypertension associated with sunitinib (23.62%) were the highest in AE reports of hypertension. 9 VEGFR-TKIs were detected with hypertension related events signs. The signals of lenvatinib were the most strong among hypertension cases associated with 9 VEGFR-TKIs. AE of hypertension mostly occurred within 30 days after VEGFR-TKIs therapy.

Conclusions The AE signals of hypertension associated with antiangiogenic TKIs were very intense. Blood pressure should be supervised more closely. It is of great significance that patients should be educated to conduct self-monitoring of blood pressure when starting VEGFR-TKIs treatment.

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