PDF(Pubmed)
Abstract：
BACKGROUND: The association between sodium-glucose cotransporter-2 (SGLT2) inhibitors and the risk of urogenital infections remains controversial. This study aimed to investigate the association between SGLT2 inhibitors and the incidence of perineal soft tissue infections, including Fournier\'s gangrene (FG), genital bacterial infections, and urinary tract infections (UTIs), using administrative claims data in Japan.
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.
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.
摘要：
背景：钠-葡萄糖协同转运蛋白-2（SGLT2）抑制剂与泌尿生殖道感染风险之间的关联仍存在争议。本研究旨在探讨SGLT2抑制剂与会阴软组织感染发生率之间的关系。包括Fournier坏疽（FG），生殖器细菌感染，尿路感染（UTI），使用日本的行政索赔数据。
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。
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。
