Table 1.
Baseline characteristics of the background population from ALTITUDE and the dapagliflozin Phase 3 programme participants included in the analysis for the subgroup with UACR >200 mg/g
| Background population (n = 1341) | Placebo (n = 31) | DAPA 5 mg (n = 33) | DAPA 10 mg (n = 28) | P-valuea | |
|---|---|---|---|---|---|
| Demographic characteristics | |||||
| Age (years) | 63.0 (9.6) | 64.4 (7.7) | 63.5 (7.5) | 62.0 (9.5) | 0.35 |
| Female, n (%) | 411 (31) | 9 (29) | 13 (38) | 6 (21) | 1.00 |
| Race, n (%) | 0.68 | ||||
| Caucasian | 641 (48) | 27 (87) | 26 (77) | 24 (86) | |
| Black | 47 (4) | 0 (0) | 1 (3) | 2 (7) | |
| Asian | 530 (39) | 2 (7) | 2 (6) | 1 (4) | |
| Other | 123 (9) | 2 (7) | 4 (12) | 1 (4) | |
| Clinical characteristics | |||||
| HbA1c (%) | 7.8 (1.6) | 8.4 (0.9) | 8.5 (1.0) | 8.2 (0.9) | 0.94 |
| Systolic BP (mmHg) | 139 (17) | 141 (15) | 143.2 (19.4) | 143.7 (19.6) | 0.47 |
| UACR (mg/g), median (IQR) | 869 (385–1795) | 618 (353–980) | 696 (449–1835) | 576 (388–1028) | 0.23 |
| Weight (kg) | 81.0 (19) | 98.4 (20) | 90.2 (15.0) | 99.2 (19.3) | 0.31 |
| Hb (g/dL) | 12.7 (1.8) | 13.4 (1.8) | 13.2 (1.3) | 13.4 (1.6) | 0.76 |
| HDL (mg/dL) | 45.9 (13.7) | 41.7 (9.5) | 39.4 (11.5) | 41.8 (8.6) | 0.59 |
| LDL (mg/dL) | 102.6 (39) | 87.9 (32) | 106.9 (43.8) | 95.1 (36.5) | 0.11 |
| Albumin (g/dL) | 4.1 (0.4) | 4.3 (0.3) | 4.0 (0.4) | 4.2 (0.3) | 0.07 |
| Potassium (mmol/L) | 4.6 (0.5) | 4.6 (0.4) | 4.4 (0.5) | 4.6 (0.5) | 0.41 |
| Phosphate (mg/dL) | 3.8 (0.7) | 3.6 (0.5) | 3.7 (0.6) | 3.8 (0.4) | 0.47 |
| Uric acid (mg/dL) | 7.2 (1.7) | 6.7 (1.7) | 7.3 (1.7) | 7.5 (1.9) | 0.08 |
| Calcium (mg/dL) | 9.3 (0.5) | 9.6 (0.4) | 9.4 (0.5) | 9.6 (0.5) | 0.17 |
Values are presented as mean (SD) unless stated otherwise.
a
P-value for the difference between placebo and dapagliflozin.