Risk of Urogenital Bacterial Infection with Sodium-Glucose Cotransporter-2 Inhibitors: A Retrospective Cohort Study Using a Claims Database.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-08-01 Epub Date: 2024-07-03 DOI:10.1007/s13300-024-01613-7

Takanori Imai, Naoto Kato, Naoki Kanda, Hideki Hashimoto, Hayato Yamana, Shuji Hatakeyama

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Abstract

Introduction: 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.

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钠-葡萄糖共转运体-2 抑制剂的泌尿生殖系统细菌感染风险：使用索赔数据库的回顾性队列研究。

简介：钠-葡萄糖共转运体-2（SGLT2）抑制剂与泌尿生殖系统感染风险之间的关系仍存在争议。本研究旨在利用日本的行政报销数据，调查 SGLT2 抑制剂与会阴部软组织感染（包括 Fournier 坏疽（FG）、生殖器细菌感染和尿路感染（UTI））发病率之间的关系：在这项回顾性队列研究中，我们使用了日本医疗数据中心的理赔数据库。研究纳入了年龄在 18 岁或以上、通过诊断代码确诊为 2 型糖尿病的患者，这些患者在 2014 年 4 月至 2020 年 8 月期间接受了 SGLT2 抑制剂或二肽基肽酶 4 (DPP-4) 抑制剂的新处方。通过一对一倾向得分（PS）匹配，我们比较了接受 SGLT2 抑制剂和 DPP-4 抑制剂治疗组之间的会阴部软组织感染（包括 FG）、生殖器细菌感染和UTI 的发生率。采用 Cox 比例危险度模型估算了危险度比 (HR) 及其 95% 置信区间 (CI)：我们确定了 34,897 名 SGLT2 抑制剂组患者和 135,311 名 DPP-4 抑制剂组患者。经过一对一的 PS 匹配后，产生了 31,665 对患者。患者的平均年龄为 51 岁，约 70% 为男性。与 DPP-4 抑制剂相比，使用 SGLT2 抑制剂可降低 UTI 风险（HR 0.90，95% CI 0.83-0.98），增加生殖器细菌感染风险（HR 1.23，95% CI 1.03-1.46）。然而，与会阴部软组织感染（HR 1.05，95% CI 0.61-1.81）无明显关联：结论：SGLT2抑制剂与UTI风险降低和生殖器细菌感染风险增加有关。与 DPP-4 抑制剂相比，SGLT2 抑制剂与会阴部软组织感染无明显关联。未来的研究应探索更广泛的人口统计学，重点关注老年人并实现性别平衡，以全面了解感染风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.