MO636: How to Prevent Genital Infections in Post-Menopausal Women with Type 2 Diabetes Mellitus Upon Initiation of Sodium–Glucose Cotransporter-2 (SGLT2) Inhibitors: A Real-Life Multi-Center Observational Study
Authors: Satta Ersilia , Alfarone Carmelo , Romano Carmine , Gentile Sandro , Guarino Giuseppina 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Patients with type 2 diabetes mellitus (T2DM) often discontinue sodium–glucose cotransporter-2-inhibitors (SGLT2 i) despite high efficacy and safety due to genital infection (GI).
SGLT2i, also called gliflozins, represent the newest class of anti-hyperglycemic agents [1] whose effects depend on the ability to dramatically reduce the threshold for maximum glucose tubular resorption rate in patients with type 2 diabetes mellitus (T2DM), with consequently enhanced glycosuria. Due to elevated urinary glucose output, T2DM increases the risk for urinary tract infections (UTIs) and non-sexually transmitted genital infections (GIs) [15]. Massive glycosuria might, indeed, already cause commensal genital microorganism overgrowth in people with T2DM [16] and is likely to increase the risk for GIs and UTIs when further aggravated by SGLT2i. To assess real-life GI risk profile in post-menopausal T2DM patients educated on strict hygiene-based prevention practices (SHBPPs) due to their intrinsic GI susceptibility.

METHOD
21 post-menopausal T2DM patients willing to follow SHBPPs were randomly assigned to three different SGLT2-Is (intervention group, IG, n = 318) or other drugs (control group, CG, n = 403) for 3 months. Before and after treatment, they underwent routine lab tests and completed a specific questionnaire. The present study was carried out by a network of five identically organized outpatient diabetes care units (DCUs) previously documented to attain the same performance levels and to come from a single institution. For the study, we specifically prepared the Female Genital Infection Symptoms Questionnaire (FGISQ) based on GIPR recommendations and checked for appropriate question comprehension and answer concordance as described below by previously administering it to 40 post-menopausal women with T2DM three times at 5-day intervals. Answer concordance was 97%. Based on a specific nurse’s inquiry and help request rate by patients completing the test, question comprehension was 98%. FGISQ consisted of sections A and B (Figure 1/A and 1/B). In greater detail, we changed question n.5 from Section A by considering that some women had Figure 1A: Female Genital Infection Symptoms Questionnaire. Part A (FGISQ-A) is addressed to the general prevention recommendations of GIs in women, taken from the recommendations (reference number 28, and Supplementary data, Table S1A, supplementary material), only six of which have been transformed into general questions. Part B (FGISQ-B), investigating GI symptoms and sexual habits is unscored and resumes GIPR questions 5 and 8 (see supplementary material), kept sexually active, and question n.8 to assess the intensity of eventually occurring GI symptoms. We also refrained from formulating any question related to recommendation n.9 as useless (all were post-menopausal, indeed).
RESULTS: GIs more often occurred (9.6%; P &lt; 0.001) among IG women non-adhering to SHBPPs (41.5%) versus the 2.9% of adhering ones. Conversely CG women had superimposable GI rates (2.7% versus 3.1%, respectively, p n.s.) whether or not adhering to SHBPPs (51.4% versus 49.6%, respectively, p n.s.). The typical profile of women on SGLT2-Is at higher risk for GIs included (i) poor adherence to SHBPPs, (ii) older age, (iii) higher BMI, (iv) poor glucose control as witnessed by high HbA1c levels, and (v) antihypertensive drug utilization.

CONCLUSION
Physicians should consider the importance of strict hygiene control in their post-menopausal T2DM patients undergoing SGLT2-I treatment and thus utilize better-focused education strategies in that specific subgroup to prevent or rehabilitate from repeated GIs.