Table 6.
Liver Function Tests—mITT Population
| Day 1a | Day 7 | Day 14 | Day 360 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arithmetic Mean ± SD | Arithmetic Mean ± SD | Arithmetic Mean ± SD | Arithmetic Mean ± SD | |||||||||
| Liver Function Parameter | LCPT (n = 29) | IR‐Tac (n = 29) | P‐Valueb | LCPT (n = 26) | IR‐Tac (n = 24) | P‐Valueb | LCPT (n = 26) | IR‐Tac (n = 22) | P‐Valueb | LCPT (n = 12) | IR‐Tac (n = 15) | P‐Valueb |
| AST (U/L) | 542.1 ± 586.89 | 386.2 ± 416.13 | .401 | 54.6 ± 30.34 | 47.3 ± 24.37 | .373 | 33.6 ± 22.36 | 44.4 ± 78.54 | .584 | 73.8 ± 109.58 | 45.8 ± 44.92 | .399 |
| ALT (U/L) | 694.2 ± 873.08 | 434.1 ± 333.8 | .127 | 161.5 ± 128.95 | 135.2 ± 91.14 | .588 | 74.4 ± 56.72 | 78.2 ± 133.08 | .916 | 79.1 ± 106.91 | 39.3 ± 30.17 | .189 |
| Tbili (mg/dL) | 3.46 ± 4.08 | 2.52 ± 1.86 | .089 | 3.66 ± 4.87 | 1.70 ± 1.04 | .019 | 1.50 ± 1.31 | 1.31 ± 0.70 | .21 | 0.92 ± 0.72 | 0.79 ± 0.46 | .26 |
ALT, alanine transaminase; AST, aspartate transaminase; IR‐Tac, twice‐daily immediate‐release tacrolimus capsules; LCPT, once‐daily extended‐release tacrolimus tablets; mITT, modified intent‐to‐treat; SD, standard deviation; Tbili, total bilirubin.
a
Day 1 refers to level drawn 24 hours after drug initiation.
b
P‐value determined by analysis of variance.