Signals mining and analysis of adverse drug events of saxagliptin based on FAERS database
10.12173/j.issn.1005-0698.202407066
- VernacularTitle:基于FAERS数据库的沙格列汀不良事件信号挖掘与分析
- Author:
Zifan HUANG
1
;
Yan LIU
;
Tianyi YANG
;
Jiaoyue LI
;
Jinlin DAI
;
Ping LI
;
Qiyao ZHAO
;
Yunpeng LUO
;
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:
Saxagliptin;
Adverse drug events;
FAERS database;
Signals mining;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(12):1346-1354
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine the real-world risk signals associated with saxagliptin-related adverse drug event(ADE),and to provide insights for evidence-based use of the drug in clinical practice.Methods Data on ADE related to saxagliptin 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,and analyzed using the reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)techniques.Results After data cleaning,the study analyzed 2 036 qualified case reports from patients who were using saxagliptin,uncovering 4 497 adverse events and identifying 131 adverse event signals across 19 system-organ classes(SOCs),including cardiac organ system diseases(20.61％),various types of investigations(10.69％),and gastrointestinal tract diseases(13.74％).Among them,heart failure,pancreatitis,pancreatic cancer,and hypoglycaemic coma were high-intensity signals.Conclusion In clinical practice,the indications for saxagliptin should be strictly managed.It is advisable to avoid using saxagliptin as monotherapy in patients with a history of heart failure or in patients at elevated risk for arteriosclerotic cardiovascular disease.Continuous monitoring of essential organ functions,especially cardiac and pancreatic,is essential throughout the course of treatment to ensure the safety of the medication.
