| アブストラクト | BACKGROUND: Ertugliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, is approved for glycemic control in type 2 diabetes mellitus (T2DM). Although clinical trials confirm its efficacy, real-world data suggest potential safety concerns. This study evaluates the post-marketing safety profile of ertugliflozin using the FDA Adverse Event Reporting System (FAERS). METHODS: FAERS data from Q1 2004 to Q4 2024 were analyzed. Reports listing ertugliflozin as the primary suspect drug were included. Duplicate and incomplete records were excluded. Disproportionality analyses were conducted using reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). Adverse events (AEs) were classified using MedDRA. RESULTS: A total of 671 reports were analyzed, encompassing 25 system organ classes and 159 preferred terms. Significant safety signals included fungal infections (ROR = 78.6), urinary tract infections (ROR = 11.3), Fournier's gangrene (ROR = 267.2), diabetic ketoacidosis (ROR = 67.6), and ketosis (ROR = 295.5). Renal AEs, notably pollakiuria (ROR = 17.1), were also observed. Serious AEs constituted 31.5 % of reports, primarily hospitalizations (20.1 %). Females (50.8 %) and patients aged >/=45 years (36.5 %) were more frequently affected. Notably, 57.6 % of AEs occurred within 30 days of treatment initiation. CONCLUSION: Ertugliflozin is associated with increased risks of metabolic, infectious, and renal adverse events, including some that are potentially life-threatening. Clinicians are advised to monitor ketone levels during the initial treatment period and to assess patients for a history of genital fungal infections prior to initiation. These steps may help mitigate early adverse events in high-risk populations. Further investigation is warranted to clarify causal pathways and inform safer clinical use. |
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| 組織名 | School of Public Health, Ningxia Medical University, Yinchuan, Ningxia, 750004,;China.;Department of Rhinology, The First Affiliated Hospital of Zhengzhou University,;Zhengzhou, Henan, 450052, China.;Department of Internal Medicine, Erasmus MC University Medical Center Rotterdam,;3015GD, Rotterdam, the Netherlands.;School of Basic Medical Sciences, Ningxia Medical University, Yinchuan, Ningxia,;750004, China.;Boston Children's Hospital, Dana Farber Cancer Institute, Harvard Medical School,;Boston, MA, 02115, USA; Department of Neurosurgery, Shanghai East Hospital,;School of Medicine, Tongji University, Shanghai, 200120, China. Electronic;address: Yue.liu@childrens.harvard.edu.;Center of Health Administration and Development Studies, Hubei University of;Medicine, Shiyan, Hubei, 442000, China. Electronic address: hbmu-hpc@qq.com. |
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