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. 2019 Jan 22;8(8):995–1008. doi: 10.1002/cpdd.657

Table 2.

Summary of Tacrolimus PK Parameters—Modified Intent‐to‐Treat Analysis Set

Day 1a Day 7 Day 14
Geometric Mean (%CV) Arithmetic Mean ± SD Geometric Mean (%CV) Arithmetic Mean ± SD Geometric Mean (%CV) Arithmetic Mean ± SD
PK Parameter LCPT (n = 29) IR‐Tac (n = 28) P‐Valueb LCPT (n = 23) IR‐Tac (n = 26) P‐Valueb LCPT (n = 21) IR‐Tac (n = 23) P‐Valueb
Total daily dose (mg) 6.48 ± 1.27 8.29 ± 2.55 9.78 ± 4.17 9.33 ± 3.77 9.43 ± 4.17 9.65 ± 4.14
(mg/kg) 0.076 ± 0.014 0.096 ± 0.017 0.122 ± 0.059 0.118 ± 0.054 0.121 ± 0.064 0.129 ± 0.070
AUC0–24h (ng · h/mL)

  • 59.57 (54.86)

  • 68.18 ± 37.40

116.17 (54.51)

135.62 ± 73.92

 <.0001

  • 231.94 (40.83)

  • 251.29 ± 102.60

  • 226.87 (41.56)

  • 245.47 ± 102.03

 .85

  • 254.24 (50.02)

  • 279.59 ± 139.86

229.55 (33.12)

241.22 ± 79.90

 .38
Cmax (ng/mL)

  • 5.06 (58.15)

  • 5.95 ± 3.46

  • 11.13 (49.48)

  • 12.70 ± 6.29

 <.0001

  • 15.41 (46.04)

  • 17.15 ± 7.90

  • 19.24 (42.52)

  • 21.10 ± 8.97

 .10

  • 18.95 (46.64)

  • 21.30 ± 9.93

  • 19.61 (63.47)

  • 22.95 ± 14.57

 .83
Cmin (ng/mL)

  • 2.55 (74.27)

  • 3.22 ±2.39

  • 3.62 (63.97)

  • 4.42 ± 2.83

 .057

  • 6.67 (48.32)

  • 7.33 ± 3.54

  • 6.83 (53.29)

  • 7.61 ± 4.06

 .85

  • 6.68 (56.27)

  • 7.41±4.17

  • 7.17 (34.95)

  • 7.56 ± 2.64

 .55
Cavg (ng/mL) 2.84 ± 1.55 5.65 ± 3.08 <.0001 10.45 ± 4.25 10.22 ± 4.24 .86 11.66 ± 5.82 10.06 ± 3.33 .37
Fluctuation (%) 95.25 ± 80.45 159.89 ± 86.33 .005 92.70 ± 48.81 134.22 ± 51.77 .007 121.82 ± 62.34 140.49 ± 81.52 .40
Swing (%) 137.92 ± 164.76 248.59 ± 183.80 .02 147.75 ± 96.90 201.52 ± 105.38 .08 204.95 ± 127.82 196.42 ± 131.51 .83
Tmax (hr) Median (min‐max) 12.00 (1.48–24.20) 2.67 (1.00–20.00) .009 4.00 (0.00–12.00) 1.51 (0.67–16.50) .03 4.00 (1.00–16.00) 2.00 (1.00–14.00) .02

AUC0–24, area under the concentration‐time curve, 0 to 24 hours; Cavg, average concentration; Cmax, maximum concentration; Cmin, minimum concentration; CV, coefficient of variation; IR‐Tac, twice‐daily immediate‐release tacrolimus capsules; LCPT, once‐daily extended‐release tablet formulation of tacrolimus; PK, pharmacokinetics; SD, standard deviation; tmax, maximum time.

a

Day 1 refers to level drawn 24 hours after drug initiation.

b

P‐value determined by analysis of variance.