Table I.
Studies identified for analysis.
| First author/s, year | Source | Groups | Dapagliflozin, mg/day | Duration of treatment, weeks | Body weight, kg mean median (SD); mean ± SD; (inter-quartile range); median [5-95th percentile] | Patient no. | Age, years | (Refs.) |
|---|---|---|---|---|---|---|---|---|
| Iacobellis and Gra-Menendez, 2020 | USA | Dapagliflozin | 10 | 24 | 104(28) | 50 | 52(9) | (13) |
| Control | - | 24 | 96.9(23) | 50 | 51(11) | |||
| Yamakage et al, 2020 | Japan | Dapagliflozin | 5 | 24 | 80.5±22.6 | 27 | 58.4±13.0 | (28) |
| Control | - | 24 | 79.0±16.3 | 27 | 60.7±11.9 | |||
| Aso et al, 2019 | Japan | Dapagliflozin | 5 | 24 | 73.6 (61.9, 80.8) | 33 | - | (8) |
| Control | - | 24 | 74.9 (65.6, 81.6) | 24 | - | |||
| Yang et al, 2018 | Asia | Dapagliflozin | 10 | 24 | 71.1±12.0 | 139 | 56.5±8.4 | (30) |
| Control | - | 24 | 72.4±13.1 | 133 | 58.6±8.9 | |||
| Yang et al, 2016 | Asia | Dapagliflozin | 5 | 24 | 70.8±12.2 | 147 | 53.1±9.1 | (29) |
| Dapagliflozin | 10 | 24 | 71.4±12.0 | 152 | 54.6±9.5 | |||
| Control | - | 24 | 70.9±11.4 | 145 | 53.5±9.2 | |||
| Matthaei et al, 2015 | - | Dapagliflozin | 10 | 52 | 88.6 (17.6) | 108 | - | (21) |
| Control | - | 52 | 90.1 (16.2) | 108 | - | |||
| Mathieu et al, 2015 | - | Dapagliflozin | 10 | 24 | 85.8±18.4 | 160 | 55.2±8.6 | (20) |
| Control | - | 24 | 88.2±18.1 | 160 | 55.0±9.6 | |||
| Cefalu et al, 2015 | Europe, Asia, USA, Canada, and Argentina | Dapagliflozin | 10 | 52 | 92.6 (20.5) | 455 | 62.8 (7.0) | (10) |
| Control | - | 52 | 93.6 (19.5) | 459 | 63.0 (7.7) | |||
| Rosenstock et al, 2015 | USA | Dapagliflozin | 10 | 24 | 87.1±18.0 | 179 | 53±10 | (22) |
| Control | - | 24 | 88.0±18.7 | 176 | 55±10 | |||
| Schumm-Draeger et al, 2015 | Europe and South Africa | Dapagliflozin | 2.5 | 16 | 92.49 (18.632) | 100 | 58.3 (9.0) | (24) |
| Dapagliflozin | 5 | 16 | 93.62 (16.641) | 99 | 55.3 (9.3) | |||
| Dapagliflozin | 10 | 16 | 90.58 (15.929) | 99 | 58.5 (9.8) | |||
| Control | - | 16 | 88.82 (15.327) | 101 | 58.5 (9.4) | |||
| Kaku et al, 2014 | Japan | Dapagliflozin | 5 | 24 | 65.81 (14.37) | 86 | 58.6 (10.4) | (15) |
| Dapagliflozin | 10 | 24 | 69.70 (13.82) | 88 | 57.5 (9.3) | |||
| Control | - | 24 | 65.96 (12.91) | 87 | 60.4 (9.7) | |||
| Leiter et al, 2014 | USA, Canada, Australia, Chile, Argentina and five European countries | Dapagliflozin | 10 | 24 | 94.5±17.8 | 480 | 63.9±7.6 | (18) |
| Control | - | 24 | 93.2±16.8 | 482 | 63.6±7.0 | |||
| Grandy et al, 2014 | Bulgaria, Czech Republic, Hungary, Poland and Sweden | Dapagliflozin | 10 | 102 | 92.1 (14.1) | 89 | 60.6 (8.2) | (11) |
| Control | - | 102 | 90.9 (13.7) | 91 | 60.8 (6.8) | |||
| Ji et al, 2014 | China, Korea and India | Dapagliflozin | 5 | 24 | 68.89 (11.43) | 128 | 53.0 (11.07) | (14) |
| Dapagliflozin | 10 | 24 | 70.92 (11.64) | 133 | 51.2 (9.89) | |||
| Control | - | 24 | 72.18 (13.23) | 132 | 49.9 (10.87) | |||
| Kohan et al, 2014 | USA, Argentina, Canada, India, Mexico, Peru, Italy, Australia, France, Spain, Denmark, Puerto Rico and Singapore | Dapagliflozin | 5 | 104 | 95.2±20.9 | 83 | 66±8.9 | (16) |
| Dapagliflozin | 10 | 104 | 93.2±17.3 | 85 | 68±7.7 | |||
| Control | - | 10 | 89.6±20.0 | 84 | 67±8.6 | |||
| Wilding et al, 2014 | Worldwide | Dapagliflozin | 2.5 | 104 | 93.0 (16.7) | 202 | 59.8 (7.6) | (27) |
| Dapagliflozin | 10 | 104 | 94.5 (16.8) | 194 | 59.3 (8.8) | |||
| Control | - | 104 | 94.5 (19.8) | 193 | 58.8 (8.6) | |||
| Lambers et al, 2013 | Canada, Netherlands and USA | Dapagliflozin | 10 | 12 | 93.2 (18.0) | 24 | 53.7 (9.4) | (17) |
| Control | - | 12 | 96.2 (19.5) | 25 | 58.0 (9.5) | |||
| Bailey et al, 2013 | Argentina, Brazil, Canada, Mexico, and USA | Dapagliflozin | 2.5 | 102 | 84.90 (17.77) | 137 | - | (9) |
| Dapagliflozin | 5 | 102 | 84.73 (16.26) | 137 | - | |||
| Dapagliflozin | 10 | 102 | 86.28 (17.53) | 135 | - | |||
| Control | - | 102 | 87.74 (19.24) | 137 | - | |||
| Rosenstock et al, 2012 | Argentina, Canada, India, Mexico, Peru, China, Philippines and USA | Dapagliflozin | 5 | 48 | 87.8±20.7 | 141 | 53.2±10.9 | (23) |
| Dapagliflozin | 10 | 48 | 84.8±22.2 | 140 | 53.8±10.4 | |||
| Control | - | 48 | 86.4±21.3 | 139 | 53.5±11.4 | |||
| Henry et al, 2012 | North America, Latin America, Europe and Asia | Dapagliflozin | 5 | 24 | 84.1 (19.5) | 194 | 51.7 (9.3) | (12) |
| Dapagliflozin | 10 | 24 | 88.4 (19.7) | 211 | 51.0 (10.1) | |||
| Control | - | 24 | 87.2 (19.4) | 208 | 52.7 (10.4) | |||
| Strojek et al, 2011 | Czech Republic, Hungary, Republic of Korea, Philippines, Poland, Thailand and Ukraine | Dapagliflozin | 2.5 | 24 | 81.89 | 154 | 59.9±10.14 | (25) |
| Dapagliflozin | 5 | 24 | 81.00 | 142 | 60.2±9.73 | |||
| Dapagliflozin | 10 | 24 | 80.56 | 151 | 58.9±8.32 | |||
| Control | - | 24 | 80.94 | 145 | 60.3±10.16 | |||
| Zhang et al, 2010 | - | Dapagliflozin | 10 | 12 | 86.6 [60.6, 115] | 45 | 55.0[41.0,71.0] | (31) |
| Dapagliflozin | 20 | 12 | 86.6 [60.6, 115] | 57 | 55.0[41.0,71.0] | |||
| Control | - | 12 | 89.8 [59.2, 122] | 49 | 52.0[34.4,70.6] | |||
| Dapagliflozin | 10 | 12 | 104 [82.0, 120] | 19 | 57.0[38.0,71.6] | |||
| Dapagliflozin | 20 | 12 | 104 [82.0, 120] | 25 | 57.0[38.0,71.6] | |||
| Control | - | 12 | 95.7 [77.3, 113] | 14 | 60.0[49.6,69.0] | |||
| Wilding et al, 2009 | USA and Canada | Dapagliflozin | 10 | 12 | 103.4±10.2 | 24 | 55.7±9.2 | (26) |
| Dapagliflozin | 20 | 12 | 101.2±15.3 | 24 | 56.1±10.6 | |||
| Control | - | 12 | 101.8±16.5 | 23 | 58.4±6.5 | |||
| List et al, 2009 | USA, Canada, Mexico and Puerto Rico | Dapagliflozin | 2.5 | 12 | 90±20 | 59 | 55±11 | (19) |
| Dapagliflozin | 5 | 12 | 89±17 | 58 | 55±12 | |||
| Dapagliflozin | 10 | 12 | 86±17 | 47 | 54±9 | |||
| Dapagliflozin | 20 | 12 | 88±18 | 59 | 55±10 | |||
| Control | - | 12 | 89±18 | 54 | 54±9 |