Table 2.
Biomarker levels at the start and end of each study period, and the difference in change between the two study periods
| Biomarker | Placebo | Dapagliflozin | Difference in Change, %a | P Valueb | ||
|---|---|---|---|---|---|---|
| Week 0 | Week 6 | Week 0 | Week 6 | |||
| Serum phosphate, mg/dl | 3.3±0.2 | 3.4±0.2 | 3.3±0.2 | 3.7±0.2 | 9 (4 to15) | 0.002 |
| Serum calcium, mg/dl | 9.4±0.4 | 9.5±0.4 | 9.4±0.4 | 9.5±0.4 | 0.4 (−2 to 0.9) | 0.56 |
| Plasma PTH, pg/ml | 42 (35–62) | 44 (32–62) | 46 (38–63) | 53 (39–75) | 16 (3 to 30) | 0.002 |
| Plasma FGF23, RU/ml | 111 (84–157) | 106 (91–181) | 113 (90–207) | 129 (103–166) | 19 (0.3 to 42) | 0.05 |
| Plasma 25(OH)D, ng/ml | 17 (13–24) | 18 (13–22) | 18 (12–24) | 16 (12–23) | 39 (−7 to 14) | 0.55 |
| Plasma 1,25(OH)2D, pg/ml | 29 (25–36) | 31 (21–37) | 34 (24–41) | 26 (19–34) | −12 (−25 to 4) | 0.12 |
| Urine phosphate, mEq/24 h | 41.4 (24.5–68.5) | 54.6 (39.8–73.5) | 45.8 (23.2–72.4) | 53.0 (35.9–79.4) | −12 (−24 to 2) | 0.10 |
| Fractional tubular reabsorption of phosphate | 0.84 (0.78–0.87) | 0.83 (0.80–0.86) | 0.84 (0.79–0.88) | 0.83 (0.80–0.87) | −0.7 (−3 to 2) | 0.53 |
| eGFR, ml/min per 1.73 m2 | 74±21 | 73±19 | 71±18 | 66±20 | −5 (−8 to −3) | 0.004 |
| Urinary albumin excretion, mg/24 h | 477 (208–1063) | 559 (271–1320) | 537 (201–973) | 283 (118–579) | −43 (−54 to −31) | <0.001 |
Data are shown as mean±SD or median (interquartile range). PTH, parathyroid hormone; FGF23, fibroblast growth factor 23; 25(OH)D, 25-hydroxyvitamin D; 1,25(OH)2D, 1,25-dihydroxyvitamin D.
a
Difference (95% confidence interval) between dapagliflozin and placebo treatment assignments in the relative change in biomarkers from beginning to end of the study periods.