Clinical safety of sodium-glucose cotransporter 2 inhibitors: a study based on adverse drug reaction monitoring data in Beijing from 2019 to 2024
10.3760/cma.j.cn114015-20250108-00019
- VernacularTitle:钠-葡萄糖共转运蛋白2抑制剂的临床安全性：基于北京地区2019—2024年药品不良反应监测数据的研究
- Author:
Yue XIE
1
;
Zhihui SONG
;
Junhan LIU
;
Huiying ZHAO
;
Guojuan ZHANG
;
Jiawei WANG
Author Information
1. 首都医科大学附属北京同仁医院药学部，北京 100730
- Publication Type:Journal Article
- Keywords:
Diabetic ketoacidosis;
Drug monitoring;
Sodium-glucose cotransporter 2 inhibitors;
Adverse drug reaction reporting systems
- From:
Adverse Drug Reactions Journal
2025;27(11):660-666
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the characteristics of adverse reactions of sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide a basis for the rational clinical application.Methods:The adverse drug reaction (ADR) cases of SGLT2i reported by Beijing from January 1, 2019 to June 30, 2024 were collected through searching the National Adverse Drug Reaction Monitoring System of China. The Medical Dictionary for Regulatory Activities (MedDRA) terminology set was used to standardize the description of ADR, and the involving system organ class (SOC) and preferred term (PT) was extracted. Data of ADR were analyzed descriptively and statistically. Results:A total of 409 SGLT2i-related adverse reaction reports involving 409 patients were included. Among these patients, there were 232 females and 177 males; the median age was 62(52, 70) years, and 231 cases (56.48%) were under the age of 65 years; 5 types of SGLT2i (dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, and henagliflozin proline) were involved, and reports of dapagliflozin was the most (279 cases, 68.22%). The primary indication for medication was diabetes (404 cases, 98.78%). The majority of ADRs did not reach the severe level (395 cases, 96.58%). The 14 cases (3.42%) of severe ADR were primarily about diabetic ketoacidosis (11 cases, 11/14), of which 7 cases presented with normal blood glucose levels and 5 cases occurred after medical stress events. The outcomes of patients were improvement in 241 cases (58.92%) and recovery in 127 cases (31.05%). In total, 476 ADR occurrences were recorded among the 409 patients, involving 82 PTs, 24 of which were not listed in the drug labels. The top 2 SOCs were the infections and infestations [26.26% (125/476)] and renal and urinary disorders [13.87% (66/476)]; the top 3 PTs were urinary tract infection [23.32% (111/476)], urinary ketone detection [6.51% (31/476)], and vulvovaginal pruritus [5.88% (28/476)]; the top 3 newly identified possible ADRs (PTs) were dizziness [2.31% (11/476)], palpitations [1.89% (9/476)], and decreased appetite [1.05% (5/476)].Conclusions:Based on the ADR monitoring data in Beijing in the past 5 and a half years, SGLT2i-associated adverse reactions primarily involved the infections and infestations, and renal and urinary disorders. ADRs identified in the study such as dizziness and palpitations are not documented in the drug labels, euglycaemic ketoacidosis accounts for a high proportion of severe reactions, and most of them occur after acute stress events.
