Signals mining and analysis of adverse drug events of pioglitazone based on FAERS database
10.12173/j.issn.1005-0698.202407064
- VernacularTitle:基于FAERS数据库的吡格列酮不良事件信号挖掘与分析
- Author:
Ping LI
1
;
Yan LIU
;
Tianyi YANG
;
Qiyao ZHAO
;
Jiaoyue LI
;
Yunpeng LUO
;
Jinlin DAI
;
Zifan HUANG
;
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:
Pioglitazone;
Thiazolidinediones;
Adverse drug event;
FAERS database;
Signal mining;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(12):1365-1374
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine adverse drug event(ADE)signals of pioglitazone,and to provide references for the safe clinical use of the medication.Methods The reporting odds ratio(ROR)method and the Bayesian confidence propagation neural network(BCPNN)method were utilized to analyze pioglitazone ADE reports from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,spanning from the first quarter of 2013 to the second quarter of 2024.Results After data cleaning,a total of 16 904 pioglitazone ADE reports were retrieved.The ADE reports primarily involved individuals over the age of 45,with a male predominance,and were mainly reported from the United States.After screening,180 ADE signals were identified,affecting 27 system-organ classes(SOC).Out of these,34 ADE signals were classified as medium to high risk,with 9 ADE signals not mentioned in the product labeling,including ureteral cancer,urethral cancer,gallbladder tumors,malignant tumors of the renal pelvis,pericardial tamponade,left ventricular dysfunction,pulmonary edema,cystitis,and somniloquy.Conclusion In addition to closely monitoring weight gain,systemic edema,and heart failure,clinical attention should be given to left ventricular dysfunction,pulmonary edema,cystitis,and pericardial tamponade ADEs that are not mentioned in the instructions,to ensure the safety of pioglitazone use in clinical practice.
