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Target trial emulation evaluates urogenital infection risks of SGLT2 inhibitors in type 2 diabetes, suggesting similar safety profiles.
Introduction and Objective: Existing evidence on urogenital infection risk associated with sodium-glucose cotransporter 2 (SGLT2) inhibitors is largely based on trials of individual agents. Therefore, the comparative safety of individual SGLT2 inhibitors on urogenital infection remains uncertain. Methods: In this target trial emulation study, we identified patients with type 2 diabetes (T2D) initiating dapagliflozin or empagliflozin in 2016-2023 using nationwide healthcare data of South Korea. They were followed from the date of study drug initiation until the earliest of outcome (urinary tract infection [UTI] or genital tract infection [GTI]), drug discontinuation or switching, death, or study end date (per-protocol approach). We used 1:1 propensity score matching to balance covariates between groups. Using Cox models, we estimated hazard ratios (HRs) and 95% confidence intervals (CIs) of UTI and GTI. Results: This study included 995 131 dapagliflozin initiators (mean age 58.7 years, male 61.2%) and 617 509 empagliflozin initiators (mean age 58.9 years, male 60.7%), with similar baseline characteristics before matching. After matching, during a mean follow-up of 1.3 years, dapagliflozin use was not associated with UTI (HR 1.00, 95% CI 0.99-1.01) and GTI (HR 0.99, 95% CI 0.97-1.00) risks compared to empagliflozin. These findings were consistent in intention-to-treat analysis. Conclusion: Dapagliflozin and empagliflozin demonstrated comparable UTI and GTI risks in patients with T2D.
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JEON et al. (2026) studied this question.
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