Age- and sex-specific risk of urogenital infections in patients with type 2 diabetes treated with sodium-glucose co-transporter 2 inhibitors: A population-based self-controlled case-series study.

This study aimed to investigate the age- and sex-specific risk of urogenital infections in patients with type 2 diabetes mellitus (T2DM) treated with sodium-glucose co-transporter 2 (SGLT2) inhibitors. A self-controlled case series was conducted using annual national patient sample datasets from 2016 and 2017. Patients who were treated with SGLT2 inhibitors and who received antimicrobials for urogenital infections were included in the study. The incidence rate ratio (IRR) of urogenital infections during SGLT2 inhibitor exposure were compared with those in the non-exposure period. A total of 2,949 patients were included in the analysis, and 71.2% of the patients were women aged ≥ 50 years. Stratified analysis by age and sex showed that only women ≥ 50 years showed a significant increase in the risk of urinary tract infections (UTIs) (IRR 1.25, 95% CI 1.14-1.37) and genital infections (IRR 1.44, 95% CI 1.28-1.62). The highest risk of UTI risk was observed 8-14 days after initiating SGLT2 inhibitor therapy (IRR 1.49, 95% CI 1.07-2.08), and after 15-28 days for genital infections (IRR 2.11, 95% CI 1.66-2.67) in women ≥ 50. SGLT2 inhibitors increase the risk of urogenital infections in T2DM patients, especially in women aged ≥ 50 years. Monitoring of urogenital infections in women aged ≥ 50 years, especially during the first month after starting SGLT2 inhibitors, is recommended.