Signals mining and analysis of adverse drug events of dapagliflozin based on FAERS database
10.12173/j.issn.1005-0698.202407063
- VernacularTitle:基于FAERS数据库的达格列净不良事件信号挖掘与分析
- Author:
Jiaoyue LI
1
;
Yan LIU
;
Qiubo YANG
;
Tianyi YANG
;
Jinlin DAI
;
Qiyao ZHAO
;
Yunpeng LUO
;
Ping LI
;
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:
Dapagliflozin;
Sodium-glucose cotransporter 2 inhibitors;
Adverse drug event;
FAERS database;
Signal mining;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(12):1336-1345
- CountryChina
- Language:Chinese
-
Abstract:
bjective To mine signals of post-marketing adverse drug events(ADEs)associated with dapagliflozin,and to provide insights for safe medication in clinical settings.Methods Data on ADEs related to dapagliflozin from U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)were collected from the first quarter of 2013 to the third quarter of 2024.The analyses involved data mining and signal monitoring using disproportionality analysis techniques including the reporting odds ratio(ROR)method,Medicines and Healthcare Products Regulatory Agency(MHRA)method,Bayesian confidence propagation neural network(BCPNN)method,and multi-item gamma Poisson shrinker(MGPS)method.Results After data cleaning,a total of 55 832 qualified dapagliflozin case reports were obtained,involving 25 090 patients,with a slightly higher percentage of males(44.99％)than females(41.18％).The predominant age group was 45 to 64 years(20.78％).A total of 379 ADE signals were detected across 22 system-organ classes(SOC).The ADEs of dapagliflozin were mainly concentrated in the SOC such as infections and infestations,general disorders and administration sites conditions,and metabolism and nutrition disorders,aligning with information provided in the drug instructions.Additionally,the ADE signals were not documented in drug inserts such as scrotal gangrene,periperineal cellulitis,scrotal abscess,hyperglycemia,ketonuria,and pancreatitis.Conclusion When clinically using dapagliflozin,it is essential to conduct a thorough medication assessment.In addition to closely monitoring diabetes ketoacidosis,fungal infection,and acute renal injury.The latent ADEs that are not mentioned in the instructions to should be noticed ensure safe medication.
