Incidence and risk of vaginal candidiasis associated with sodium-glucose cotransporter 2 inhibitors in real-world practice for women with type 2 diabetes

Abstract

Aims/introduction: The prevalence and risk of vaginal candidiasis before and after initiating sodium-glucose cotransporter 2 (SGLT2) inhibitors, although some clinical trials have been carried out, have not been adequately shown in real-world practice. We investigated the incidence of vaginal Candida colonization and symptomatic vaginitis, and the clinical risk factors including diabetic microvascular complications.

Materials and methods: The participants were 114 women with type 2 diabetes who were free of vaginitis symptoms and started SGLT2 inhibitors. Vaginal candidiasis tests through self-administered swabs were carried out at baseline, 6 and 12 months.

Results: Before starting SGLT2 inhibitors, 17 participants (14.9%) had positive vaginal Candida colonization. Younger age and the presence of microangiopathy were significantly associated with the positive colonization in multivariate analysis. Among all participants, 23 (20.2%, 8 because of vaginitis and 15 for other reasons) discontinued SGLT2 inhibitors before reaching the 6-month test. Of 65 participants who were negative for Candida at baseline and received the 6-month test, 24 (36.9%) converted to a positive culture, and multivariate analysis showed older age as an independent risk for developing Candida colonization. There were 18 participants (15.8%) who developed symptomatic vaginitis, and they showed similar characteristics to the 24 participants. Most of those with negative cultures at 6 months showed negative results at 12 months and vice versa.

Conclusions: The rates of developing positive colonization and symptomatic vaginitis after starting SGLT2 inhibitors appear to be higher in real-world practice than the rates of 31% and 5-10% in clinical trials, respectively. Risk factors of vaginal Candida colonization might be different before and after taking SGLT2 inhibitors.

Keywords: Real-world practice; Sodium-glucose cotransporter 2 inhibitors; Vaginal candidiasis.