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

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

Affiliation: 1. 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: Saxagliptin Adverse drug events FAERS database Signals mining Pharmacovigilance

DOI: 10.12173/j.issn.1005-0698.202407066

Reference: HUANG Zifan, LIU Yan, YANG Tianyi, LI Jiaoyue, DAI Jinlin, LI Ping, ZHAO Qiyao, LUO Yunpeng, ZHANG Li, YANG Xiaohui[J]. Signals mining and analysis of adverse drug events of saxagliptin based on FAERS database[J].Yaowu Liuxingbingxue Zazhi, 2024, 33(12): 1336-1345. DOI: 10.12173/j.issn.1005-0698.202407066.[Article in Chinese]  Copied

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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.

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