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- W2059995890 abstract "Abstract Tacrolimus (TAC) is considered a critical dose drug. The purpose of our study was to investigate circadian and time‐dependent changes in TAC pharmacokinetics over the first year after kidney transplantation. Pharmacokinetic (PK) studies were performed in 26 recipients of first living donor kidney transplants at day 7 after morning (a.m.) and evening (p.m.) doses of TAC. Additional serial PK studies were carried out in nine patients at month 6 (M6) and month 12 (M12). Blood samples were collected before 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 h after TAC administration. Demographics, TAC and adjunctive immunosuppressive doses, hematology, and biochemistry were recorded in each PK study. Mean age was 37 years, body mass index 23 kg/m 2 , 58% males, and 85% Caucasian. Higher AUC (231.4 vs. 220 ng·h/mL, P = 0.06) and C max (34.1 ± 12.6 vs. 24.4 ± 9.8 ng/mL, P < 0.001), and lower T max (1.6 ± 0.8 vs. 2.7 ± 2.0 h, P = 0.05) values were observed comparing a.m. and p.m. administrations. Comparing D7, M6 and M12, there was a significant increase in dose‐normalized AUC (31.4 ± 22.2 vs. 50.1 ± 33 vs. 39.2 ± 24.4 ng·h/mL/mg, P = 0.005), C max (4.4 ± 2.4 vs. 7.8 ± 3.5 vs. 6.0 ± 3.3 ng/mL/mg, P < 0.001) and T max (1.6 ± 1.1 vs. 1.7 ± 0.4 vs. 1.8 ± 0.8 h, P = 0.006), respectively. Over the first year the intraindividual variability of dose‐normalized AUC, C max and C 0 were 82%, 72%, and 90%, respectively. No significant changes were observed comparing inter‐individual variability of dose‐normalized AUC (21%, 24%, 33%), C max (46%, 45%, 55%), C 0 (49%, 83%, 81%) at D7, M6 and M12, respectively. We observed a good correlation between a.m. and p.m. TAC AUC ( r 2 = 0.90) and C 0 ( r 2 = 0.88). Tacrolimus pharmacokinetics display circadian variation suggesting a slower and delayed absorption phase at nighttime. Tacrolimus also showed time‐dependent PK changes, suggesting an improvement in absorption during the first 6 months. Despite circadian variation we observed good correlations between a.m. and p.m. TAC AUC ( r 2 = 0.90) and C 0 ( r 2 = 0.88) and between C 0 and total daily TAC exposure (a.m. + p.m. AUC) suggesting that trough‐guided therapeutic monitoring is still a reliable and simple strategy to optimize the clinical use of TAC." @default.
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- W2059995890 date "2007-01-19" @default.
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- W2059995890 title "Circadian and time-dependent variability in tacrolimus pharmacokinetics" @default.
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- W2059995890 doi "https://doi.org/10.1111/j.1472-8206.2007.00468.x" @default.
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