Abstract

Abstract Introduction Sodium-glucose cotransporter 2 inhibitors (SGLT-2i) have become common pharmacotherapies in the treatment of type 2 diabetes mellitus. These agents are well described to increase the risk of genitourinary infections. Fournier's gangrene (FG), is a rare, life-threatening, necrotizing genitourinary infection with risk factors including diabetes, obesity, alcohol abuse, poor hygiene, immune suppression, malignancy, and HIV.1 An increased risk of FG has also been associated with the use of SGLT-2i; however, the exact risk of FG in association with SGLT-2i use is unknown. Hypothesis We hypothesized that SGLT-2i therapy did NOT increase the risk of FG when compared to other treatments for type 2 diabetes. Methodology We used the TriNetX database tool to search clinical data available within the Froedtert and the Medical College of Wisconsin system. The database was searched to identify patients with a diagnosis of type 2 diabetes and FG. From this data, we identified the number of patients with type 2 diabetes mellitus who developed FG based upon treatment with and without SGLT-2i exposure within 12 months. Patient characteristics including BMI, renal function, glycemic control, age, sex, tobacco use, and alcohol use were compared in both treatment arms. Results Data from 1.54 million patients showed that 143,330 (∼9.3%) carry a diagnosis of type 2 diabetes mellitus. Of these patients, 49,950 were treated with a SGLT-2i as part of their therapy while 44,510 patients were treated with oral antiglycemic agents without SGLT-2i exposure. Two hundred sixty of the 143,330 patients with diabetes (0.181%) developed FG. During a period of 12 months, 140 of 49,950 (0.280%) patients treated with a SGLT-2i developed FG. Whereas 120 of 44,510 (0.269%) without SGLT-2i therapy within a 12 month period developed FG. Patients’ characteristics (including sex, age, BMI, renal function, glycemic control, history of tobacco use, and alcohol use) were similar between the SGLT-2i therapy group and the group without SGLT-2i exposure. Conclusion We conclude patients treated with oral therapies for type 2 diabetes developed FG with similar frequencies regardless of exposure to SGLT-2i therapy. Patients with FG had similar characteristics and known risk factors regardless of SGLT-2i therapy utilization. Further study is required to determine if the previously noted association of FG and SGLT-2i treatment is due to the increased number of risk factors in the population receiving SGLT-2i therapy rather than the SGLT-2i themselves.

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