METHODS: In this retrospective cohort study, we utilized the JMDC Claims Database. The study included patients aged 18 years or older diagnosed with type 2 diabetes mellitus, identified by a diagnostic code, who received new prescriptions for SGLT2 inhibitors or dipeptidyl peptidase 4 (DPP-4) inhibitors between April 2014 and August 2020. Using one-to-one propensity score (PS) matching, we compared the incidence of perineal soft tissue infections, including FG, genital bacterial infection, and UTIs between groups treated with SGLT2 and DPP-4 inhibitors. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using the Cox proportional hazards model.
RESULTS: We identified 34,897 patients in the SGLT2 inhibitor group and 135,311 patients in the DPP-4 inhibitor group. After one-to-one PS matching, 31,665 pairs were generated. The mean age of the patients was 51 years, with approximately 70% being male. The use of SGLT2 inhibitors was associated with a decreased risk of UTI (HR 0.90, 95% CI 0.83-0.98) and an increased risk of genital bacterial infection (HR 1.23, 95% CI 1.03-1.46) compared to DPP-4 inhibitors. However, no significant association was observed with perineal soft tissue infection (HR 1.05, 95% CI 0.61-1.81).
CONCLUSIONS: SGLT2 inhibitors were associated with a reduced risk of UTI and an increased risk of genital bacterial infection. They showed no significant association with perineal soft tissue infection when compared to DPP-4 inhibitors. Future research should explore broader demographics, focusing on the elderly and achieving gender balance, to gain a comprehensive understanding of infection risks.
方法:在这项回顾性队列研究中,我们使用了JMDC索赔数据库。该研究包括18岁或以上被诊断患有2型糖尿病的患者,由诊断代码识别,2014年4月至2020年8月接受SGLT2抑制剂或二肽基肽酶4(DPP-4)抑制剂新处方.使用一对一的倾向评分(PS)匹配,我们比较了会阴软组织感染的发生率,包括FG,生殖器细菌感染,SGLT2和DPP-4抑制剂治疗组之间的UTI。使用Cox比例风险模型估计风险比(HR)及其95%置信区间(CI)。
结果:我们在SGLT2抑制剂组中确定了34,897名患者,在DPP-4抑制剂组中确定了135,311名患者。一对一的PS匹配后,产生了31,665对。病人的平均年龄是51岁,大约70%是男性。与DPP-4抑制剂相比,SGLT2抑制剂的使用与UTI风险降低(HR0.90,95%CI0.83-0.98)和生殖器细菌感染风险增加(HR1.23,95%CI1.03-1.46)相关。然而,与会阴软组织感染无显著相关性(HR1.05,95%CI0.61-1.81).
结论:SGLT2抑制剂与UTI风险降低和生殖器细菌感染风险增加相关。与DPP-4抑制剂相比,它们与会阴软组织感染没有显着关联。未来的研究应该探索更广泛的人口统计学,以老年人为重点,实现性别平衡,全面了解感染风险。