Table 1.
Characteristics of the studies included in the review
| Study | Design | treatment target | patient population | Intervention | Control | Outcomes |
|---|---|---|---|---|---|---|
| Liu et al. [9] | Prospective, single-arm, pilot trial | Proteinuric CKD | Age 6–18 years, eGFR less than 60 mL/min/1.73 m2, urinary protein greater than 0.2 g/24-hr, stable on an ACE inhibitor, without history of immunosuppressive therapy or diabetes | Dapagliflozin 5 mg (30 kg or less) or 10 mg (greater than 30 kg) PO daily for 12 weeks | N/A | 22.6% reduction in proteinuria (95% CI 8.3%–36.9%) |
| Mean eGFR 103.8±28.2 vs 109.2±32.0 at baseline (P=0.048) | ||||||
| No discontinuations due to adverse events | ||||||
| Newland et al. 2022 [10] | Retrospective, single-arm, cohort study | Heart failure | Age less than 21 years , left ventricular ejection fraction less than 55% or impaired ventricular filling, symptoms of low cardiac output and/or congestion | Dapagliflozin 0.1-0.2 mg/kg PO daily up to 10 mg per dose | N/A | Mean serum BMP reduced from 222 pg/mL at baseline to 166 pg/mL at a median follow-up of 130 days (P=0.04) |
| Mean eGFR reduced from 118 mL/min/1.73 m2 at baseline to 100 mL/min/1.73 m2 at follow-up (P=0.09) | ||||||
| Biester et al. 2017 [11] | Prospective, double-blind, randomized, crossover trial | Type 1 diabetes mellitus | Age 12–21 years, HbA1c 12.5% or less, insulin total daily dose 0.6–2 units/kg by continuous insulin pump or multiple injections, BMI 18 to 35 kg/m2 (adults) or 10th to 99th percentile (pediatrics) | Dapagliflozin 10 mg PO single dose | Placebo | Mean daily insulin requirement 0.92±0.2 vs. 1.10±0.17 units/kg/day with placebo P<0.001 |
| Mean post-prandial insulin 0.28±0.05 vs. 0.31±0.06 units/kg/day with placebo (P=0.0504 | ||||||
| Mean serum β-hydroxybutyrate 0.17±0.13 vs. 0.11±0.08 mmol/L (P<0.0001) | ||||||
| Biester et al. 2020 [12] | Prospective, double-blind, randomized, crossover trial | Type 1 diabetes mellitus | Age 12–21 years, HbA1c 6.5%–11%, no recent DKA, continuous insulin pump at least 3 months, mean insulin daily dose 0.6- 2 units/kg, BMI 18 to 35 kg/ m2 (adults) or 10th to 99th percentile (pediatrics) | Dapagliflozin 10 mg PO, day 1 at 1900 and day 2 at 0630 | Placebo | Time in blood glucose range (70–180 mg/dL) 68%±7% vs. 50%±13% with placebo (P<0.001) |
| Mean insulin daily dose 31 units±10 units vs. 40 units±13 units (P=0.004) | ||||||
| Mean serum β-hydroxybutyrate level 0.29 vs. 0.16 mmol/L with placebo (P<0.0001) | ||||||
| Tamborlane et al. 2022 [13] | Prospec tive, double-blind, randomized, Phase 3 clinical trial | Type 2 diabetes mellitus | Age 10–24 years, HbA1c 6.5%–11%, FPG 225 mg/dL or less, metformin at least 1,000 mg daily for 8 weeks and/or stable insulin, currently engaged in diet and exercise | Dapagliflozin 10 mg PO daily for 24 weeks (double-blind) plus a 28-week open-label extension | Placebo for 24 weeks plus dapagliflozin during a 28 week open-label extension | Mean HbA1c vs. placebo -0.75% (95% CI, -1.65–0.15) |
| Met treatment goal of HbA1c less than 7%, 25.0% vs 4.0% with placebo (P=0.056) | ||||||
| Adverse events 69% vs. 58% with placebo serious adverse events 5% vs. 9% with placebo |
CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; PO, orally; N/A, not available; CI, confidence interval; BMP, basic metabolic panel; HbA1c, glycosylated hemoglobin; DKA, diabetic ketoacidosis; FPG, fasting plasma glucose; BMI, body mass index.