Table 3.
Mean values(95% CI) and differences between means(95% CI) for the dose-normalized exposure indices of mycophenolic acid and metabolites at 30 days post-transplant
| Sirolimus group | Ciclosporin group | Differences | P | |
|---|---|---|---|---|
| Mycophenolic acid | ||||
| C0 (mg L−1) dose−1 | 3.8 (2.1; 5.5) | 1.5 (1.1; 1.9) | 2.3 (0.8; 3.8) | 0.0141 |
| Cmax (mg L−1) dose−1 | 12.8 (10.0; 15.7) | 11.7 (8.1; 15.2) | 1.3 (−3.9; 6.4) | 0.2710 |
| Tmax (h) | 0.9 (0.7; 1.2) | 1.6 (0.7; 2.5) | 0.7 (−0.5; 1.8) | 0.2237 |
| AUC0–9h (mg h−1 L−1) dose−1 | 51.1 (39.8; 62.3) | 34.0 (28.1; 39.9) | 17.1 (5.0; 29.2) | 0.0066 |
| Mycophenolic-acid-phenyl-glucuronide | ||||
| C0 (mg L−1) dose−1 | 88.2 (57.8; 118.5) | 101.7 (78.2; 125.2) | 13.5 (−26.3; 53.4) | 0.4531 |
| Cmax (mg L−1) dose−1 | 137.5 (102.6; 172.3) | 164.5 (130.6; 198.3) | 27.0 (−26.1; 80.1) | 0.2478 |
| Tmax (h) | 2.1 (1.5; 2.8) | 3.0 (2.3; 3.7) | 0.9 (−0.2; 2.0) | 0.0964 |
| AUC0-9h (mg h−1 L−1) dose−1 | 980.0 (689.5; 1270.5) | 1200.4 (933.8; 1466.9) | 220.4 (−204.4; 645.7) | 0.1679 |
| Mycophenolic-acid-acyl-glucuronide | ||||
| C0 (mg L−1) dose−1 | 0.2 (0.1; 0.2) | 0.2 (0.1; 0.2) | 0.0 (−0.1; 0.1) | 0.3010 |
| Cmax (mg L−1) dose−1 | 0.4 (0.3; 0.6) | 0.7 (0.5; 0.9) | 0.3 (−0.1; 0.6) | 0.0257 |
| Tmax (h) | 1.7 (1.2; 2.2) | 2.2 (1.6; 2.8) | 0.5 (−0.4; 1.4) | 0.2237 |
| AUC0–9h (mg h−1 L−1) dose−1 | 2.0 (1.2; 2.7) | 3.3 (2.5; 4.2) | 1.4 (0.1; 2.7) | 0.0167 |
| Mycophenolic-acid-phenyl-glucoside | ||||
| C0 (mg L−1) dose−1 | 0.1 (0.0; 0.1) | 0.1 (0.1; 0.1) | 0.0 (0.0; 0.1) | 0.8235 |
| Cmax (mg L−1) dose−1 | 0.3 (0.1; 0.4) | 0.7 (0.5; 1.0) | 0.5 (0.1; 0.8) | 0.0024 |
| Tmax (h) | 1.7 (1.5; 1.9) | 2.2 (1.7; 2.6) | 0.5 (−0.1; 1.1) | 0.0426 |
| AUC0–9h (mg h−1 L−1) dose−1 | 1.1 (0.; 1.5) | 3.0 (2.1; 3.8) | 1.9 (0.7; 3.0) | 0.0018 |