Genital but Not Urinary Tract Infections Associated with SGLT2 Inhibitor Use: A Real-World Cohort Study from Portugal
DOI:
https://doi.org/10.71749/pkj.146Keywords:
Diabetes Mellitus, Type 2/drug therapy, Sodium-Glucose Transporter 2 Inhibitors/adverse effects, Urinary Tract Infections/chemically inducedAbstract
Introduction: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) provide cardio-renal-metabolic benefits in type 2 diabetes mellitus (T2DM), although concern persists regarding genitourinary infections. This study assessed the incidence of genitourinary infections among patients with T2DM treated with SGLT2i in Portuguese primary care, by infection type, individual agent, and dosage, and evaluated treatment discontinuation and predictors of infection.
Methods: This multicentric retrospective cohort study used electronic health records from Portuguese primary care centers. Adults with T2DM receiving pharmacological treatment between 2019 and 2023 were classified according to SGLT2i use. Genitourinary infection incidence was compared between groups, with infections identified through clinical records, laboratory data, or targeted antimicrobial prescriptions.
Results: A total of 5865 patients were included: 2997 treated with SGLT2i and 2868 with other glucose-lowering agents. Overall genitourinary infections occurred in 9.8% of SGLT2i users and 11.1% of controls (OR 0.87, 95% CI 0.74-1.03; p = 0.109). Urinary tract infections were not increased with SGLT2i: cystitis 6.5% vs 10.1%; OR 0.62, 95% CI 0.52-0.75), pyelonephritis (0.2% vs 0.5%; OR 0.48, 95% CI 0.19-1.18), and prostatitis in male patients (0.4% vs 0.8%; OR 0.53, 95% CI 0.21-1.37). Genital mycotic infections were more frequent with SGLT2i: balanitis in male patients (2.7% vs 0.7%; OR 3.93, 95% CI 1.98-7.81) and vulvovaginal mycotic infection in female patients (3.5% vs 1.5%; OR 2.37, 95% CI 1.42-3.96). Treatment discontinuation due to infection occurred in 1.8%.
Conclusion: SGLT2i were associated with higher genital mycotic infection occurrence, but not with increased urinary tract infection risk, supporting their safety in routine care.
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Data Availability Statement
The data supporting the findings of this study are not publicly available due to ethical and confidentiality restrictions, as they contain clinical information from participants.
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Copyright (c) 2026 Helena Martins, João Grilo, Salomé Silva, Sofia Oliveira, Rita Santos, Carolina Pereira, Ana Martinho, Inês Pinto, Cláudia Silva, Ricardo Rodrigues, Ana Cabrita, Ana Ferreira, Luís Afonso, Luís Neves, Luís Rodrigues, Inês Rosendo
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