TABLE 2.
Tacrolimus TDD, trough levels and trough:TDD by period (mITT population).
| TDD, mean (SD), mg | LCPT (N = 200) | IR-Tac/PR-Tac (N = 201) | IR-Tac (N = 86) | PR-Tac (N = 115) |
|---|---|---|---|---|
| Week 3 to Month 6 | 5.17 (2.97) | 6.28 (3.56) | 5.54 (2.91) | 6.81 (3.88) |
| Overall | 5.85 (3.08) | 6.96 (3.65) | 6.33 (3.24) | 7.43 (3.88) |
| Week 1 | 10.96 (3.08) | 11.72 (3.16) | 11.34 (3.02) | 12.01 (3.26) |
| Week 2 | 8.75 (4.01) | 9.54 (4.55) | 8.76 (3.94) | 10.10 (4.87) |
| Week 3 | 8.07 (4.20) | 9.20 (4.86) | 8.17 (3.78) | 9.93 (5.40) |
| Week 4 | 7.41 (4.02) | 8.57 (4.64) | 7.47 (3.66) | 9.36 (5.11) |
| Months 1–3 | 5.80 (3.27) | 7.00 (3.80) | 6.23 (3.37) | 7.56 (4.01) |
| Months 3–6 | 4.45 (2.87) | 5.44 (3.23) | 4.82 (2.74) | 5.91 (3.50) |
| Trough Levels, Mean (SD), ng/ml | ||||
| Week 3 to Month 6 | 9.40 (1.72) | 9.00 (1.67) | 8.86 (1.51) | 9.11 (1.78) |
| Overall | 10.69 (2.58) | 10.11 (2.12) | 10.60 (2.46) | 9.76 (1.76) |
| Week 1 | 13.96 (5.91) | 13.07 (5.05) | 14.59 (5.22) | 11.94 (4.63) |
| Week 2 | 10.65 (3.67) | 9.66 (3.60) | 10.24 (3.54) | 9.24 (3.60) |
| Week 3 | 10.70 (4.42) | 9.91 (3.38) | 10.45 (3.11) | 9.52 (3.52) |
| Week 4 | 10.47 (3.52) | 9.96 (3.04) | 9.76 (2.54) | 10.12 (3.38) |
| Months 1–3 | 9.69 (2.22) | 9.36 (2.42) | 9.23 (2.70) | 9.45 (2.27) |
| Months 3–6 | 8.37 (1.87) | 8.04 (1.78) | 7.84 (1.89) | 8.21 (1.69) |
| Trough:TDD Mean (SD), ng/ml mg−1 | ||||
| Week 3 to Month 6 | 2.26 (1.38) | 1.69 (0.85) | 1.90 (0.97) | 1.54 (0.73) |
| Week 1 | 1.22 (0.69) | 1.09 (0.63) | 1.29 (0.69) | 0.94 (0.54) |
| Week 2 | 1.46 (0.99) | 1.26 (0.91) | 1.38 (0.70) | 1.18 (1.03) |
| Week 3 | 1.68 (1.14) | 1.33 (0.86) | 1.58 (1.07) | 1.16 (0.62) |
| Week 4 | 1.77 (1.08) | 1.44 (0.93) | 1.66 (1.13) | 1.27 (0.69) |
| Months 1–3 | 2.23 (1.51) | 1.68 (0.96) | 1.91 (1.09) | 1.51 (0.82) |
| Months 3–6 | 2.62 (1.80) | 1.87 (0.95) | 2.06 (1.05) | 1.72 (0.83) |
IR-Tac, immediate release tacrolimus; LCPT, LCP tacrolimus; mITT, modified intent-to-treat; PR-Tac, prolonged release tacrolimus; SD, standard deviation; TDD, total daily dose.