MON-230 Safety Profile of Sodium-Glucose Cotransport-2 Inhibitors in a Large, Children’s Hospital System

Abstract Disclosure: O. Ginnard: None. A.D. Nguyen: None. R. Schneider Aguirre: None. Sodium-glucose cotransport-2 inhibitors (SGLT2i) have shifted the paradigm type 2 diabetes (T2D), heart failure, and chronic kidney disease treatment and have a well-known profile of benefits and possible adverse events in adults. Unsurprisingly, the question of translatability to the pediatric population arose. Until June, 2023, when empagliflozin was approved for use in pediatric T2D, any use of SGLT2i in pediatrics was off-label. Thus, the real-world risk profile in the pediatric population is not nearly as well-known. To better understand the safety profile in pediatrics, a retrospective study was undertaken in patients treated with SGLT2i at a major children’s hospital system at the time of SGLT2i initiation. Patient demographics, anthropomorphic data, vitals, medications, indication for SGLT2i use, laboratories and any studies performed were collected. A total of 32 patients were reviewed. The average age of treatment start was 17 years (range: 4.5-22.4), 44% were male, 78% were white, 23% were black, 56% were Hispanic. Indications for SGLT2i use included: diabetes (type 2 or steroid-induced, 22%), cardiac disease alone (22%), renal disease alone (3%), combination of cardiac disease and diabetes (41%), combination of diabetes and renal disease (3%), and unclear indication (9%). SGLT2i used included dapagliflozin (78%), empagliflozin (13%), and canagliflozin (9%). The mean duration of SGLT2i use was 12.05 months with a range from 0.03 months to 14.9 months. 42% were on other diabetes medications such as metformin, liraglutide, and/or insulin. 58% were on other cardiology medications such as anti-platelet or anticoagulants, cholesterol, hypertension, diuretic, anti-mineralocorticoid, semaglutide and/or anti-arrhythmia medications. 6% were on other renal medications such as ACE-I/ARB or hypertensive medications. Adverse events did not cause discontinuation in any patient although in some, lack of insurance coverage prevented continuation after hospital discharge. There were 0 hospitalizations and 0 deaths attributed to SGLT2i use. During treatment, there were 4 individuals with volume depletion, 7 with acute kidney injury (AKI), 0 fractures, 0 amputations, 0 episodes of symptomatic hypoglycemia, 1 episode of DKA, 0 episodes of Fornier’s gangrene, 2 episodes of urinary tract infections, and 0 mycotic infections. None of these episodes were explicitly attributed to SGLT2i use in the chart and at least 1 AKI was attributed to venous congestion and need for increased diuresis. The one incident of DKA occurred in a patient with known diabetes prior to SGLT2i treatment. Based upon this chart review, the real world risk profile of SGLT2i in a pediatric population is similar to adults with no major new safety signals identified, thus substantiating the safety of another promising therapy for diabetes, cardiac, and renal treatment in the pediatric population. Presentation: Monday, July 14, 2025