Table 1.
Baseline characteristics.
| Characteristic | Rapid metabolizers | Intermediate metabolizers | Slow metabolizers | |||
|---|---|---|---|---|---|---|
| LCPT (n=82) | IR-Tac (n=82) | LCPT (n=83) | IR-Tac (n=85) | LCPT (n=82) | IR-Tac (n=82) | |
| Age (years), mean (SD) | 42.5 (12.87) | 43.6 (13.61) | 44.4 (12.95) | 45.6 (14.58) | 46.2 (13.69) | 49.0 (14.64) |
| Sex, n (%) | ||||||
| Male | 51 (62.2%) | 56 (68.3%) | 54 (65.1%) | 53 (62.4%) | 59 (72.0%) | 58 (70.7%) |
| Female | 31 (37.8%) | 26 (31.7%) | 29 (34.9%) | 32 (37.6%) | 23 (28.0%) | 24 (29.3%) |
| Race, n (%) | ||||||
| White | 55 (67.1%) | 59 (72.0%) | 64 (77.1%) | 69 (81.2%) | 65 (79.3%) | 63 (76.8%) |
| Black or African American | 7 (8.5%) | 6 (7.3%) | 0 | 5 (5.9%) | 2 (2.4%) | 3 (3.7%) |
| Asian | 4 (4.9%) | 4 (4.9%) | 5 (6.0%) | 2 (2.4%) | 1 (1.2%) | 4 (4.9%) |
| Other | 16 (19.5%) | 13 (15.9%) | 14 (16.9%) | 9 (10.6%) | 14 (17.1%) | 12 (14.6%) |
| Donor type, n (%) | ||||||
| Living | 42 (51.2%) | 37 (45.1%) | 45 (54.2%) | 36 (42.4%) | 41 (50.0%) | 44 (53.7%) |
| Deceased | 40 (48.8%) | 45 (54.9%) | 38 (45.8%) | 49 (57.6%) | 41 (50.0%) | 38 (46.3%) |
| Previous transplant, n (%) | 4 (4.9%) | 1 (1.2%) | 7 (8.4%) | 6 (7.1%) | 0 | 4 (4.9%) |
| Treatment duration (days), mean (SD) | 569.5 (256.23) | 634.6 (192.13) | 669.0 (153.26) | 633.0 (199.57) | 621.6 (206.44) | 637.2 (192.09) |
| C/D ratio* | <0.96 | <0.86 | 0.96–1.53 | 0.86–1.38 | >1.53 | >1.38 |
Analysis population consisted of patients who had a calculable day 30 C/D ratio based on central or local laboratory data. C/D – concentration/dose; IR-Tac – immediate-release tacrolimus; LCPT – LCP-tacrolimus; SD – standard deviation.
*
C/D ratio cutoffs differ between formulations because of inherent differences in bioavailability; LCPT has a higher bioavailability resulting in lower average doses.