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Vaginal candidiasis more likely with real-world use of SGLT2 inhibitors vs. clinical trials
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Women with type 2 diabetes who begin taking SGLT2 inhibitors are at higher risk for developing vaginal candidiasis and symptomatic vaginitis than clinical trials previously indicated, according to study results published in the Journal of Diabetes Investigation.
“Although clinical trials showed the rate of discontinuing SGLT2 inhibitors and developing vaginitis after starting SGLT2 inhibitors, the incidence of vaginal Candida colonization and symptomatic vaginitis and risk in terms of clinical features and diabetic microvascular complications have not been adequately investigated in real-world practice,” Hiroki Yokoyama, MD, PhD, of the department of internal medicine at Jiyugaoka Medical Clinic in Obihiro, Japan, and colleagues wrote.
Researchers enrolled 114 women with type 2 diabetes (mean age, 53.3 years) who attended the outpatient clinic of Jiyugaoka Internal Medicine in 2015. Participants were initiating SGLT2 inhibitors and had no symptoms of vaginitis. Participants self-administered a vaginal swab before (baseline) and at 6 and 12 months after beginning SGLT2 inhibitor therapy.
At baseline, 17 women tested positive for vaginal candidiasis. They were younger than those without colonization at baseline (mean age, 46.6 years vs. 54.4 years; P < .01) and had higher HbA1c levels (8.3% vs. 7.4%; P < .01) and estimated glomerular filtration rate (92.9 vs. 80.1 mL/min/1.73 m2; P < .05) and more of them had angiopathy (76.5% vs. 47.4%; P < .05). After multiple logistic regression analysis, researchers determined that age (OR = 0.94; 95% CI, 0.89-0.99 per year) was associated with candidiasis at baseline, possibly related to sexual activity, as was presence of angiopathy (OR = 4; 95% CI, 1.1-15.1).
At 6 months after initiating SGLT2 inhibitor treatment, 40 participants dropped out of the study for various reasons (early development of symptomatic vaginal candidiasis, refusal of the 6-month test, no effect or frequent urination). Of the remaining 74, nine had Candida growth initially, whereas the remaining 65 did not. Of those, 24 (36.9%) exhibited positive cultures and 15.8% developed candidiasis symptoms after 6 months. At 6 months, Candida presence was significantly associated with older age (OR = 1.08; 95% CI, 1.02-1.14 per year) and being postmenopausal (OR = 5.01; 95% CI, 1.45-17.31)
“Young age, which was a risk factor for Candida growth before SGLT2 inhibitors treatment, may be associated with estrogen-stimulated glycogen content of the vaginal epithelium, which could serve as an energy source for Candida,” the researchers wrote. “When elderly subjects, despite postmenopausal loss of estrogenic stimulation and decreased glycogen content before SGLT2 inhibitor treatment, are once exposed to high urine glucose excretion under a condition accompanied with microvascular impairment due to diabetes, Candida colonization is likely to occur.”
At 1-year of follow-up, 49 participants remained; 25 participants either stopped taking SGLT2 inhibitors (n = 13) or did not reach the 12-month test for other reasons (n = 12). In those who remained, researchers found rates of 3.1% and 8.1%, respectively, in the development of positive Candida colonization and symptomatic candidiasis.
“These rates of vaginal Candida colonization and symptomatic vaginitis found in real-world practice appeared to be higher as compared to the findings in clinical trials,” the researchers wrote. – by Phil Neuffer
Disclosures: The authors report no relevant financial disclosures.
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