Table 2.
Changes in hemoglobin and serum iron indices after ferumoxytol or oral iron therapy (ITT Population)a
Treatment Group | Baseline | Day 21 | Change at Day 21 | P for Day 21 Changeb | Day 35 | Change at Day 35 | P for Day 35 Changeb |
---|---|---|---|---|---|---|---|
Hemoglobin (g/dl) | |||||||
Ferumoxytol | 10.59 ± 0.67 | 11.41 ± 1.23 | 0.71 ± 1.07 | 0.0067 | 11.72 ± 1.20 | 1.02 ± 1.13 | 0.0002 |
Oral iron | 10.69 ± 0.57 | 11.09 ± 1.07 | 0.35 ± 0.90 | 11.22 ± 1.22 | 0.46 ± 1.06 | ||
TSAT (%) | |||||||
Ferumoxytol | 15.71 ± 7.21 | 22.00 ± 12.17 | 6.22 ± 12.12 | 0.0015 | 22.31 ± 13.33 | 6.44 ± 12.59 | <0.0001 |
Oral iron | 15.91 ± 6.29 | 17.08 ± 9.54 | 1.39 ± 8.88 | 16.46 ± 9.72 | 0.55 ± 8.34 | ||
Ferritin (ng/ml) | |||||||
Ferumoxytol | 340.52 ± 159.07 | 749.49 ± 301.63 | 356.66 ± 247.12 | <0.0001 | 601.79 ± 282.95 | 233.93 ± 206.95 | <0.0001 |
Oral iron | 357.56 ± 171.65 | 316.24 ± 173.51 | −37.56 ± 106.98 | 289.30 ± 165.76 | −59.23 ± 106.22 | ||
Serum iron (μg/dl) | |||||||
Ferumoxytol | 49.49 ± 20.20 | 60.06 ± 31.54 | 10.84 ± 31.40 | 0.1328 | 58.64 ± 27.88 | 9.20 ± 27.77 | 0.0557 |
Oral iron | 48.23 ± 18.73 | 53.07 ± 24.78 | 4.87 ± 23.33 | 51.02 ± 26.28 | 2.61 ± 21.71 | ||
TIBC (μg/dl) | |||||||
Ferumoxytol | 322.36 ± 76.78 | 280.26 ± 67.83 | −41.25 ± 57.02 | <0.0001 | 275.67 ± 60.71 | −45.88 ± 52.53 | <0.0001 |
Oral iron | 313.89 ± 65.84 | 310.67 ± 65.86 | −4.16 ± 46.87 | 319.62 ± 67.29 | 4.21 ± 50.26 | ||
CHr (pg) | |||||||
Ferumoxytol | 31.12 ± 2.62 | 32.42 ± 2.60 | 1.32 ± 1.59 | <0.0001 | 32.22 ± 2.69 | 1.09 ± 1.64 | <0.0001 |
Oral iron | 31.57 ± 2.48 | 31.68 ± 2.42 | 0.07 ± 1.46 | 31.56 ± 2.39 | 0.00 ± 1.46 |
Mean ± SD data are presented.
Two-sample t-tests evaluated treatment differences in changes from baseline.
TIBC, total iron binding capacity; CHr, reticulocyte hemoglobin content; TSAT, transferrin saturation.