Signals mining and analysis of adverse drug events of lixisenatide based on FAERS database

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Author: DAI Jinlin ^1# LIU Yan ^2# YANG Tianyi ³ LI Jiaoyue ¹ HUANG Zifan ¹ LUO Yunpeng ¹ LI Ping ¹ ZHAO Qiyao ¹  ZHANG Li ⁴  YANG Xiaohui ¹

Affiliation: 1. Department of Nephrology and Endocrinology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China 2. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China 3. Rutgers University, New Brunswick, New Jersey 08901, USA 4. Department of Scientific Research, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China

Keywords: Lixisenatide Glucagon-like peptide-1 receptor agonist Adverse drug events FAERS database Signal mining Pharmacovigilance

DOI: 10.12173/j.issn.1005-0698.202407067

Reference: DAI Jinlin, LIU Yan, YANG Tianyi, LI Jiaoyue, HUANG Zifan, LUO Yunpeng, LI Ping, ZHAO Qiyao, ZHANG Li, YANG Xiaohui. Signals mining and analysis of adverse drug events of lixisenatide based on FAERS database[J]. Yaowu Liuxingbingxue Zazhi, 2024, 33(12): 1325-1335. DOI: 10.12173/j.issn.1005-0698.202407067.[Article in Chinese]  Copied

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Abstract

Objective To investigate post-marketing adverse drug event (ADE) signals associated with lixisenatide, and to provide guidance for safe clinical use.

Methods The ADE reporting data of lixisenatide ADE were mined and the signals were detected from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter 2013 to the second quarter 2024 using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method.

Results After data cleaning, a total of 5 162 ADE reports with lixisenatide as the primary suspected drug were collected. The 85 ADE signals identified by the two statistical analysis methods, affected 14 system-organ classes (SOC). They were primarily concentrated in injuries, poisonings, and procedural complications (25.88%), various examinations (14.12%), systemic diseases and reactions at administration sites (14.12%), gastrointestinal diseases (9.41%), and various neurological diseases (5.88%). There were 28 ADE signals such as pancreatitis, visual impairment, and color blindness, that were not included in the drug instructions.

Conclusion In addition to monitoring for common ADE associated with GLP-1 receptor agonists such as hypoglycemia, gastrointestinal, and neurological effects, clinicians should also be vigilant for underlying ADE like pancreatic-related diseases, eye toxicity reaction when using lixisenatide to ensure safe and rational medication use.

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