TABLE 2.
Tacrolimus pharmacokinetic parameters by race and sex groups (n = 65)
|
Parameter Mean (SD) |
Black females (n = 13) | Black males (n = 20) | White females (n = 16) | White males (n = 16) | p‐Values for the effect of | Significant pairwise comparisons (Tukey adjusted) | ||
|---|---|---|---|---|---|---|---|---|
| Race | Sex | Race × Sex interaction | ||||||
| Primary measured pharmacokinetic parameters | ||||||||
| C12 h trough (ng/ml) | 7.5 (1.4) | 8.0 (2.0) | 6.8 (2.1) | 6.5 (1.4) | 0.021 | 0.800 | 0.439 | BM vs. WM p = 0.098 |
| Cmax (ng/ml) a | 22.9 (11.5) | 19.4 (6.7) | 18.8 (8.6) | 13.8 (3.7) | 0.012 | 0.067 | 0.452 |
BF vs. WM p = 0.021 BM vs. WM p = 0.071 |
| AUC0‐12 (ng h/ml) | 134.7 (31.7) | 138.5 (32.5) | 123(31.9) | 106.3(21.4) | 0.005 | 0.389 | 0.178 |
BM vs. WM p = 0.011 BF vs. WM p = 0.061 |
| AUC0‐4h (ng h/ml) b | 62.1 (20.3) | 60.2 (17.5) | 54.5 (17.5) | 44.1(10.9) | 0.007 | 0.157 | 0.293 |
BF vs. WM p=0.030 BM vs. WM p = 0.027 |
| Cl (L/h) a | 40.0(16.8) | 28.2 (13.2) | 22.2 (8.9) | 21.3 (6.8) | <0.001 | 0.066 | 0.085 |
BF vs. WF p = 0.002 BF vs. WM p = 0.001 BF vs. BM p = 0.062 |
| Cl/TBW a (L/h/kg) | 0.47 (0.23) | 0.34 (0.20) | 0.32 (0.15) | 0.23(0.07) | 0.007 | 0.006 | 0.515 |
BF vs. WM p = 0.002 BF vs. BM p = 0.075 |
| Dose normalized pharmacokinetic parameters: represents 1 mg tacrolimus exposure | ||||||||
| C12h trough dose a (ng/ml/mg) | 1.61 (0.60) | 2.68 (1.78) | 3.04 (1.60) | 3.20 (1.10) | <0.001 | 0.025 | 0.192 |
BF vs. WF p = 0.005 BF vs. WM p < 0.001 BF vs. BM p = 0.062 |
| C max/dose a (ng/ml/mg) | 5.12 (2.97) | 5.96 (2.67) | 8.15 (4.01) | 6.70 (2.45) | 0.013 | 0.825 | 0.149 | BF vs. WF p = 0.042 |
| AUC0‐12 dose a (ng∙h/ml/mg) | 29.6 (12.5) | 44.9 (25.5) | 54.6 (25.9) | 51.7 (16.8) | <0.001 | 0.084 | 0.068 |
BF vs. WF p = 0.002 BF vs. WM p = 0.002 |
Data displayed as mean (standard deviation). Significant p values are denoted by bold type.
Abbreviations: AUC, area under the concentration vs. time curve; B, Blacks; C12hr, 12‐hour trough concentration; CLss, steady state oral clearance; C max, maximum concentration; F, females; M, males; SD, standard deviation; TBW, total body weight; T max, time to maximum concentration; W, White.
Parameters that were log transformed during statistical analysis.
Square root transformation of parameter.