TABLE 5.
Tacrolimus trough:TDD (mITT).
| No. patients | LCPT (N = 200) | IR-Tac/PR-Tac (N = 201) | Difference (LCPT—IR-Tac/PR-Tac) | ||
|---|---|---|---|---|---|
| LS mean, ng/ml mg−1 | LS mean, ng/ml mg−1 | LS mean (95% CI), ng/ml mg−1 | p-value | ||
| Week 3 to Month 6 a | 385 | 2.27 | 1.70 | 0.57 (0.34, 0.80) | <0.001 |
| Week 1 b | 396 | 1.22 | 1.09 | 0.14 (0.01, 0.26) | 0.034 |
| Week 2 b | 389 | 1.47 | 1.26 | 0.21 (0.02, 0.40) | 0.030 |
| Week 3 b | 352 | 1.67 | 1.32 | 0.34 (0.14, 0.54) | <0.001 |
| Week 4 b | 334 | 1.82 | 1.46 | 0.36 (0.15, 0.57) | <0.001 |
| Months 1–3 b | 376 | 2.27 | 1.70 | 0.57 (0.31, 0.82) | <0.001 |
| Months 3–6 b | 364 | 2.65 | 1.89 | 0.76 (0.47, 1.06) | <0.001 |
a
ANOVA model including treatment and country as fixed effects.
b
MMRM model including treatment, period, treatment by period interaction, and country as fixed effects.
ANOVA, analysis of variance; CI, confidence interval; IR-Tac, immediate release tacrolimus; LCPT, LCP tacrolimus; LS, least squares; mITT, modified intent-to-treat; MMRM, mixed model for repeated measures; PR-Tac, prolonged release tacrolimus; TDD, total daily dose.