The Use of Dapagliflozin in Infants and Children with Heart Failure.

Dapagliflozin has been shown to improve outcomes in adult heart failure (HF) but has not been widely evaluated in pediatrics. The present study describes dapagliflozin use and adverse events (AEs) in infants and children with HF. This descriptive, single-center retrospective review included pediatric patients with HF or recent heart transplant who were started on dapagliflozin and treated for any duration between 9/2020 and 5/2024. Descriptive statistics were used to summarize clinical characteristics, AEs, anthropometrics, and laboratory values during treatment. Of 120 patients (40.8% female, 16.7% <1 year of age), 78 (65.0%) had congenital heart disease, 33 (27.5%) had cardiomyopathy, and 6 (5.0%) were post-heart transplant. Median age at dapagliflozin initiation was 9.5 years (range 0-20). Median dose was 0.16 mg/kg/day (range 0.08-0.38), though this varied by age. The cumulative treatment duration was 25,551 days (median 128, IQR 40-354). The most common AEs were AKI (0.215/100 patient days, 32 patients affected), UTI (0.059/100 patient days, 10 patients affected), and hypoglycemia (0.106/100 patient days, 12 patients affected). The incidence of both AKI and hypoglycemia were higher in infants compared to older children. In 9 patients (7.5%), AEs prompted medication discontinuation. The remainder continued therapy or stopped for unrelated reasons. Notably, weight z-score did not decline and log BNP improved among our cohort over the study period. Dapagliflozin was well tolerated in infants and children with HF when used alongside standard medical therapy. These data call for multicenter, prospective studies to further characterize the efficacy of dapagliflozin in this high-risk population.