Table 3.
Effects of ferric derisomaltose compared to usual care for patients classified by serum ferritin concentration
| Serum ferritin concentration | ≤30 µg/L | >30 to <100 µg/L | ≥100 μg/L* | P for interaction | |||
|---|---|---|---|---|---|---|---|
| Usual Care | FDI | Usual Care | FDI | Usual Care | FDI | ||
| 146 | 151 | 317 | 310 | 102 | 108 | ||
| Haemoglobin (g/dL) | |||||||
| Value at 4 months | 12.5 (1.5) | 13.4 (1.3) | 12.2 (1.4) | 12.7 (1.3) | 12.0 (1.4) | 12.3 (1.4) | |
| Difference in change from baseline | 1.0 (0.6 to 1.3) | 0.5 (0.3 to 0.7) | 0.5 (0.1 to 0.8) | .028 | |||
| MLwHF score overall (n) | 129 | 263 | 90 | 91 | |||
| Value at 4 months | 40 (25) | 37 (27) | 40 (27) | 37 (27) | 42 (27) | 39 (28) | |
| Difference at 4 months | −3 (−10 to +3) | −3 (−8 to +1) | −3 (−11 to +5) | 1.0 | |||
| MLwHF score physical | |||||||
| Value at 4 months | 20 (11) | 17 (11) | 20 (12) | 18 (12) | 21 (12) | 19 (12) | |
| Difference at 4 months | −3 (−6 to 0) | −2 (−4 to +0) | −1 (−5 to +2) | .77 | |||
| MLwHF score emotional | |||||||
| Value at 4 months | 9 (8) | 9 (8) | 9 (8) | 8 (8) | 9 (7) | 9 (8) | |
| Difference at 4 months | +0 (−2 to +2) | −1 (−2 to +1) | −1 (−3 to +2) | .67 | |||
| 6-Minute walk test (n) | 65 | 64 | 124 | 149 | 38 | 44 | |
| Distance at 4 months (m) | 291 (120) | 287 (140) | 287 (139) | 281 (130) | 240 (116) | 280 (122) | |
| Difference usual care vs. FDI | −4 (−50 to +41) | −6 (−38 to +26) | +40 (−12 to +93) | .36 | |||
| Primary endpoint | |||||||
| Rate per 100 patient-years | 17.6% | 13.8% | 28.4% | 25.2% | 39.7% | 26.9% | |
| Rate ratio | 0.79 (0.47 to 1.31) | 0.90 (0.68 to 1.18) | 0.66 (0.42 to 1.06) | .57 | |||
| Absolute difference in rate | 3.8% lower with FDI | 3.2% lower with FDI | 12.8% lower with FDI | ||||
| Primary endpoint (COVID sensitivity) | |||||||
| Rate per 100 patient-years | 16.4% | 12.6% | 30.8% | 26.4% | 43.7% | 24.3% | |
| Rate ratio | 0.76 (0.41 to 1.43) | 0.87 (0.62 to 1.23) | 0.53 (0.29 to 0.98) | .39 | |||
| Absolute difference in rate | 3.8% lower with FDI | 4.4% lower with FDI | 19.4% lower with FDI | ||||
| CV mortality | |||||||
| Percentage (%) | 13.7% | 13.9% | 27.8% | 24.5% | 27.5% | 20.4% | |
| Hazard ratio | 1.08 (0.59 to 2.00) | 0.87 (0.64 to 1.19) | 0.70 (0.40 to 1.22) | .46 | |||
| Absolute difference in percentages (%) | 0.2% higher with FDI | 3.3% lower with FDI | 7.1% lower with FDI | ||||
| CV mortality (COVID sensitivity) | |||||||
| Percentage (%) | 5.8% | 9.2% | 19.4% | 15.1% | 20.0% | 11.0% | |
| Hazard ratio | 1.66 (0.69 to 4.01) | 0.76 (0.51 to 1.12) | 0.56 (0.26 to 1.18) | .15 | |||
| Absolute difference in percentages (%) | 3.4% higher with FDI | 4.3% lower with FDI | 9.0% lower with FDI | ||||
| All-cause mortality | |||||||
| Percentage (%) | 24.7% | 27.2% | 36.0% | 36.5% | 40.2% | 27.8% | |
| Hazard ratio | 1.17 (0.75 to 1.83) | 1.01 (0.78 to 1.31) | 0.65 (0.41 to 1.05) | .16 | |||
| Absolute difference in percentages (%) | 2.5% higher with FDI | 0.5% higher with FDI | 12.4% lower with FDI | ||||
| All-cause mortality (COVID sensitivity) | |||||||
| Percentage (%) | 12.9% | 14.6% | 24.1% | 22.1% | 25.3% | 15.0% | |
| Hazard ratio | 1.07 (0.61 to 1.88) | 0.90 (0.64 to 1.26) | 0.59 (0.31 to 1.13) | .14 | |||
| Absolute difference in percentages (%) | 1.7% higher with FDI | 2.0% lower with FDI | 10.3% lower with FDI | ||||
Substantial differences in rates are highlighted in bold. MLwHF, Minnesota Living with Heart Failure.
*TSAT <20% required if ferritin ≥100 μg/L. One patient assigned to usual care did not have a measurement of TSAT but is included here.