Signals mining and analysis of adverse drug events of lixisenatide based on FAERS database
10.12173/j.issn.1005-0698.202407067
- VernacularTitle:基于FAERS数据库的利司那肽不良事件信号挖掘与分析
- Author:
Jinlin DAI
1
;
Yan LIU
;
Tianyi YANG
;
Jiaoyue LI
;
Zifan HUANG
;
Yunpeng LUO
;
Ping LI
;
Qiyao ZHAO
;
Li ZHANG
;
Xiaohui YANG
Author Information
1. 北京中医药大学东直门医院肾病内分泌科(北京 100700)
- Publication Type:Journal Article
- Keywords:
Lixisenatide;
Glucagon-like peptide-1 receptor agonist;
Adverse drug events;
FAERS database;
Signal mining;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(12):1325-1335
- CountryChina
- Language:Chinese
-
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.
