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Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver Transplantation, A randomized phase III substudy

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Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver Transplantation, A randomized phase III substudy. / Ericzon, Bo-Göran; Varo, Evaristo; Trunečka, Pavel; Fischer, Lutz; Colledan, Michele; Gridelli, Bruno; Valdivieso, Andrés; O'Grady, John; Dickinson, James; Undre, Nasrullah.

In: CLIN TRANSPLANT, Vol. 31, No. 6, 06.2017.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Ericzon, B-G, Varo, E, Trunečka, P, Fischer, L, Colledan, M, Gridelli, B, Valdivieso, A, O'Grady, J, Dickinson, J & Undre, N 2017, 'Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver Transplantation, A randomized phase III substudy', CLIN TRANSPLANT, vol. 31, no. 6. https://doi.org/10.1111/ctr.12958

APA

Ericzon, B-G., Varo, E., Trunečka, P., Fischer, L., Colledan, M., Gridelli, B., Valdivieso, A., O'Grady, J., Dickinson, J., & Undre, N. (2017). Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver Transplantation, A randomized phase III substudy. CLIN TRANSPLANT, 31(6). https://doi.org/10.1111/ctr.12958

Vancouver

Ericzon B-G, Varo E, Trunečka P, Fischer L, Colledan M, Gridelli B et al. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver Transplantation, A randomized phase III substudy. CLIN TRANSPLANT. 2017 Jun;31(6). https://doi.org/10.1111/ctr.12958

Bibtex

@article{0b9fcea2812e48ada86c046254488849,
title = "Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver Transplantation, A randomized phase III substudy",
abstract = "BACKGROUND: With the same dose of tacrolimus, lower systemic exposure on the first day of dosing has been reported for prolonged-release tacrolimus compared with immediate-release tacrolimus, prompting investigation of differing initial doses.METHODS: This substudy of a double-blind, randomized, phase III trial in de novo liver transplant recipients compared the pharmacokinetics of once-daily prolonged-release tacrolimus (initial dose: 0.2 mg/kg/day) versus twice-daily immediate-release tacrolimus (initial dose: 0.1 mg/kg/day) during the first 2 weeks post-transplant.RESULTS: Pharmacokinetic data were analyzed from patients receiving prolonged-release tacrolimus (n=13) and immediate-release tacrolimus (n=12). Mean systemic exposure (AUC0-24 ) was higher with prolonged-release versus immediate-release tacrolimus. Dose-normalized AUC0-24 (normalized to 0.1 mg/kg/day) showed generally lower exposure with prolonged-release tacrolimus versus immediate-release tacrolimus. There was good correlation between AUC0-24 and concentration at 24 hours after the morning dose (r=.96 and r=.86, respectively), and the slope of the line of best fit was similar for both formulations.CONCLUSIONS: Doubling the initial starting dose of prolonged-release tacrolimus compared with immediate-release tacrolimus overcompensated for lower exposure on Day 1. A 50% higher starting dose of prolonged-release tacrolimus than immediate-release tacrolimus may be required for similar systemic exposure. However, doses of both formulations can be optimized using the same trough-level monitoring system. (ClinicalTrials.gov number: NCT00189826).",
keywords = "Journal Article",
author = "Bo-G{\"o}ran Ericzon and Evaristo Varo and Pavel Trune{\v c}ka and Lutz Fischer and Michele Colledan and Bruno Gridelli and Andr{\'e}s Valdivieso and John O'Grady and James Dickinson and Nasrullah Undre",
note = "{\textcopyright} 2017 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.",
year = "2017",
month = jun,
doi = "10.1111/ctr.12958",
language = "English",
volume = "31",
journal = "CLIN TRANSPLANT",
issn = "0902-0063",
publisher = "Wiley-Blackwell",
number = "6",

}

RIS

TY - JOUR

T1 - Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver Transplantation, A randomized phase III substudy

AU - Ericzon, Bo-Göran

AU - Varo, Evaristo

AU - Trunečka, Pavel

AU - Fischer, Lutz

AU - Colledan, Michele

AU - Gridelli, Bruno

AU - Valdivieso, Andrés

AU - O'Grady, John

AU - Dickinson, James

AU - Undre, Nasrullah

N1 - © 2017 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.

PY - 2017/6

Y1 - 2017/6

N2 - BACKGROUND: With the same dose of tacrolimus, lower systemic exposure on the first day of dosing has been reported for prolonged-release tacrolimus compared with immediate-release tacrolimus, prompting investigation of differing initial doses.METHODS: This substudy of a double-blind, randomized, phase III trial in de novo liver transplant recipients compared the pharmacokinetics of once-daily prolonged-release tacrolimus (initial dose: 0.2 mg/kg/day) versus twice-daily immediate-release tacrolimus (initial dose: 0.1 mg/kg/day) during the first 2 weeks post-transplant.RESULTS: Pharmacokinetic data were analyzed from patients receiving prolonged-release tacrolimus (n=13) and immediate-release tacrolimus (n=12). Mean systemic exposure (AUC0-24 ) was higher with prolonged-release versus immediate-release tacrolimus. Dose-normalized AUC0-24 (normalized to 0.1 mg/kg/day) showed generally lower exposure with prolonged-release tacrolimus versus immediate-release tacrolimus. There was good correlation between AUC0-24 and concentration at 24 hours after the morning dose (r=.96 and r=.86, respectively), and the slope of the line of best fit was similar for both formulations.CONCLUSIONS: Doubling the initial starting dose of prolonged-release tacrolimus compared with immediate-release tacrolimus overcompensated for lower exposure on Day 1. A 50% higher starting dose of prolonged-release tacrolimus than immediate-release tacrolimus may be required for similar systemic exposure. However, doses of both formulations can be optimized using the same trough-level monitoring system. (ClinicalTrials.gov number: NCT00189826).

AB - BACKGROUND: With the same dose of tacrolimus, lower systemic exposure on the first day of dosing has been reported for prolonged-release tacrolimus compared with immediate-release tacrolimus, prompting investigation of differing initial doses.METHODS: This substudy of a double-blind, randomized, phase III trial in de novo liver transplant recipients compared the pharmacokinetics of once-daily prolonged-release tacrolimus (initial dose: 0.2 mg/kg/day) versus twice-daily immediate-release tacrolimus (initial dose: 0.1 mg/kg/day) during the first 2 weeks post-transplant.RESULTS: Pharmacokinetic data were analyzed from patients receiving prolonged-release tacrolimus (n=13) and immediate-release tacrolimus (n=12). Mean systemic exposure (AUC0-24 ) was higher with prolonged-release versus immediate-release tacrolimus. Dose-normalized AUC0-24 (normalized to 0.1 mg/kg/day) showed generally lower exposure with prolonged-release tacrolimus versus immediate-release tacrolimus. There was good correlation between AUC0-24 and concentration at 24 hours after the morning dose (r=.96 and r=.86, respectively), and the slope of the line of best fit was similar for both formulations.CONCLUSIONS: Doubling the initial starting dose of prolonged-release tacrolimus compared with immediate-release tacrolimus overcompensated for lower exposure on Day 1. A 50% higher starting dose of prolonged-release tacrolimus than immediate-release tacrolimus may be required for similar systemic exposure. However, doses of both formulations can be optimized using the same trough-level monitoring system. (ClinicalTrials.gov number: NCT00189826).

KW - Journal Article

U2 - 10.1111/ctr.12958

DO - 10.1111/ctr.12958

M3 - SCORING: Journal article

C2 - 28295581

VL - 31

JO - CLIN TRANSPLANT

JF - CLIN TRANSPLANT

SN - 0902-0063

IS - 6

ER -