| アブストラクト | BACKGROUND: Sodium-glucose cotransporter 2 inhibitors (SGLT-2is) manage type 2 diabetes mellitus (T2DM) via increased urinary glucose excretion; however, their use is associated with an elevated risk of genitourinary infections. This study aims to evaluate this risk by synthesizing evidence from randomized controlled trials (RCTs) and characterizing clinical features using data from the FDA Adverse Event Reporting System (FAERS). METHODS: In this systematic review and meta-analysis, we searched PubMed and Embase up to June 2024 for RCTs reporting genital mycotic infection (GMI) and urinary tract infection (UTI) events associated with SGLT-2is. The primary outcome was the risk of GMI and UTI related to SGLT-2is, quantified using the risk ratio (RR) with a 95% confidence interval (CI). Additionally, a retrospective pharmacovigilance study of FAERS extracted the cases of genitourinary infections related to SGLT-2is up to June 2024. Disproportionality was calculated using the frequentist and bayesian based data mining algorithms. RESULTS: A total of 98 RCTs (91,756 participants) were included, treatment with SGLT-2is significantly increased the risk of GMI compared to placebo (RR: 3.65, 95% CI: 3.22- 4.14, p = <0.0001) and active control (RR: 4.29; 95% CI: 3.42-5.38, p = <0.0001). Subgroup analysis showed significant differences by individual drug, gender, and duration. Disproportionality analysis revealed significant signals for all SGLT-2is with genitourinary tract infections, persisting after signal refinement. CONCLUSION: SGLT-2is significantly increase the risk of GMI among T2DM patients, while the association with UTI remains inconsistent. Additional research is required to elucidate the potential risk factors. |
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| ジャーナル名 | Endocrine |
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| Pubmed追加日 | 2025/8/24 |
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| 投稿者 | Yoosuf, Beema T; Kt, Muhammed Favas; D P, Spoorthy; Saini, Aasar; Garg, Prabha; Medenica, Sanja; Dutta, Pinaki; Bansal, Dipika |
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| 組織名 | Department of Pharmacy Practice, National Institute of Pharmaceutical Education;and Research (NIPER), SAS Nagar (Mohali), Punjab, India.;Department of Pharmacoinformatics, National Institute of Pharmaceutical Education;Department of Endocrinology, Internal Medicine Clinic, Clinical Centre of;Montenegro, Faculty of Medicine, University of Montenegro, Podgorica, Montenegro.;Department of Endocrinology, Postgraduate Institute of Medical Education and;Research, Chandigarh, India.;dipikabansal079@gmail.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40849605/ |
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