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STUDY TO KNOW THE PREVALENCE OF URINARY TRACT INFECTIONS IN TYPE II DIABETIC PATIENTS TAKING DAPAGLIFLOZIN

Dr Abdul Sallam Sajid, Dr Muhammad Usman Hasan, Dr Ghulam Ali Hasnan

Objective: In type 2 diabetes, the most common complication is Urinary tract infection. The most common causing factors are glucosuria, treatment with sodium glucose cotransporter 2 inhibitors (SGLT2). Dapagliflozin is a research proved SGLT2 inhibitor with proven controls over glycemia in patients of diabetes mellitus. Dapagliflozin data from several safety trials were checked to prove the asoociation between urinary tract infection and glycosuria. Study Design: A Randomized Control trial. Place and Duration: In the Medicine Departments of Services Hospital Lahore for one year duration from June 2017 to June 2018. Methods: The randomized controlled safety data of 12 placebo-controlled studies were collected to assess the association between glycosuria and UTI in non compliance diabetes mellitus patients (HbA1c N6.5% - 12%). The subjects were given once daily with either dapagliflozin (2.5, 5 or 10 mg) or placebo, either for 12 to 24 weeks or as as monotherapy in addition to insulin, metformin, thiazolidination or sulfonylurea. Clinical diagnosis and incidence of UTI were evaluated. Results: This study consisted of 3050 patients who were given monotherapy or supplementary treatment and received dapagliflozin (31 mg [n = 790], 5 mg [n = 1080] or 10 mg [n = 1180] once a day and 1380 placebo patients were treated. For 10 mg, 5 mg, 2.5 mg and placebo for dapagliflozin, the identified infections were recorded as 5.6%,3.7%, 3.8% and 4.2% respectively. In the urine, the levels of glucose were gradually increased with the dose of dapagliflozin but not the urinary tract infection incidence increases. Most of the identified infections were diseases that were typical for diabetes mellitus patients. Interruption in urine due to UTI was rare: 8 (0.3%) patients managed with dapagliflozin and in 1 (0.1%) cases treated with placebo. The antimicrobial standard therapy were given for detected infections in mild to moderate form. Conclusion: With 5 or 10 mg dapagliflozin on daily for the type 2 diabetes mellitus treatment is associated with a slightly high UTI risk. Most of the time the mild to moderate infection was observed and easily treatable. This study did not show a definite dose association between urinary tract infection and glycosuria. Key Words: Dapagliflozin, Urinary tract infection, type 2 diabetes, glycosuria.

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