Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial.

Lutz Fischer; Pavel Trunečka; Bruno Gridelli; Andre Roy; Alessandro Vitale; Andrés Valdivieso; Evaristo Varo; Daniel Seehofer; Stephen Lynch; Didier Samuel; Bo-Goran Ericzon; Karim Boudjema; Carmen Karpf; Nasrullah Undre

Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial.

Standard

Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial. / Fischer, Lutz; Trunečka, Pavel; Gridelli, Bruno; Roy, Andre; Vitale, Alessandro; Valdivieso, Andrés; Varo, Evaristo; Seehofer, Daniel; Lynch, Stephen; Samuel, Didier; Ericzon, Bo-Goran; Boudjema, Karim; Karpf, Carmen; Undre, Nasrullah.

in: LIVER TRANSPLANT, Jahrgang 17, Nr. 2, 2, 2011, S. 167-177.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Fischer, L, Trunečka, P, Gridelli, B, Roy, A, Vitale, A, Valdivieso, A, Varo, E, Seehofer, D, Lynch, S, Samuel, D, Ericzon, B-G, Boudjema, K, Karpf, C & Undre, N 2011, 'Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial.', LIVER TRANSPLANT, Jg. 17, Nr. 2, 2, S. 167-177. <http://www.ncbi.nlm.nih.gov/pubmed/21280190?dopt=Citation>

APA

Fischer, L., Trunečka, P., Gridelli, B., Roy, A., Vitale, A., Valdivieso, A., Varo, E., Seehofer, D., Lynch, S., Samuel, D., Ericzon, B-G., Boudjema, K., Karpf, C., & Undre, N. (2011). Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial. LIVER TRANSPLANT, 17(2), 167-177. [2]. http://www.ncbi.nlm.nih.gov/pubmed/21280190?dopt=Citation

Vancouver

Fischer L, Trunečka P, Gridelli B, Roy A, Vitale A, Valdivieso A et al. Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial. LIVER TRANSPLANT. 2011;17(2):167-177. 2.

Bibtex

@article{15eb4eeee117415a937352ed6137c811,

title = "Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial.",

abstract = "Tacrolimus, a cornerstone immunosuppressant, is available as a twice-daily formulation (tacrolimus bid). A once-daily prolonged-release formulation (tacrolimus qd) has been developed. This 6-week, randomized, phase 2, multicenter, open-label, prospective trial in primary liver transplant recipients investigated and compared the pharmacokinetics (PK) of tacrolimus for qd and bid formulations. All patients received tacrolimus-based immunosuppression (tacrolimus qd, n = 67; bid, n = 62). PK data were available for 77 patients (tacrolimus qd, n = 45; bid, n = 32). Tacrolimus area under the curve (AUC) from 0 to 24 hours (AUC(0-24) ) at equivalent doses was approximately 50% lower for tacrolimus qd than for bid on day 1 (146 versus 264 ng · h/mL, respectively), but by day 14 was comparable between treatments (324 and 287 ng · h/mL, respectively) with higher tacrolimus qd doses. There was a strong correlation between AUC(0-24) and concentration at 24 hours for tacrolimus qd and bid (r = 0.92 and r = 0.76, respectively). Furthermore, the relationship between these 2 parameters (ie, the slope of the line) was also similar for the 2 formulations. Efficacy endpoints were comparable for both formulations at 6 weeks with no marked differences in incidence, nature, or severity of adverse events between treatments (although the study was not powered to draw efficacy conclusions). These results suggest that targeting the same trough levels will achieve similar total AUC over 24 hours for both tacrolimus qd and tacrolimus bid in de novo liver transplant recipients.",

keywords = "Adult, Humans, Male, Aged, Female, Middle Aged, Young Adult, Prospective Studies, Treatment Outcome, Europe, Kaplan-Meier Estimate, Drug Administration Schedule, Administration, Oral, Drug Therapy, Combination, Delayed-Action Preparations, Australia, Therapeutic Equivalency, *Liver Transplantation, Canada, Area Under Curve, Graft Rejection/immunology/prevention & control, Graft Survival/drug effects, Immunosuppressive Agents/administration & dosage/adverse effects/*pharmacokinetics, Tacrolimus/administration & dosage/adverse effects/*pharmacokinetics, Adult, Humans, Male, Aged, Female, Middle Aged, Young Adult, Prospective Studies, Treatment Outcome, Europe, Kaplan-Meier Estimate, Drug Administration Schedule, Administration, Oral, Drug Therapy, Combination, Delayed-Action Preparations, Australia, Therapeutic Equivalency, *Liver Transplantation, Canada, Area Under Curve, Graft Rejection/immunology/prevention & control, Graft Survival/drug effects, Immunosuppressive Agents/administration & dosage/adverse effects/*pharmacokinetics, Tacrolimus/administration & dosage/adverse effects/*pharmacokinetics",

author = "Lutz Fischer and Pavel Trune{\v c}ka and Bruno Gridelli and Andre Roy and Alessandro Vitale and Andr{\'e}s Valdivieso and Evaristo Varo and Daniel Seehofer and Stephen Lynch and Didier Samuel and Bo-Goran Ericzon and Karim Boudjema and Carmen Karpf and Nasrullah Undre",

year = "2011",

language = "English",

volume = "17",

pages = "167--177",

journal = "LIVER TRANSPLANT",

issn = "1527-6465",

publisher = "John Wiley and Sons Ltd",

number = "2",

}

RIS

TY - JOUR

T1 - Pharmacokinetics for once-daily versus twice-daily tacrolimus formulations in de novo liver transplantation: a randomized, open-label trial.

AU - Fischer, Lutz

AU - Trunečka, Pavel

AU - Gridelli, Bruno

AU - Roy, Andre

AU - Vitale, Alessandro

AU - Valdivieso, Andrés

AU - Varo, Evaristo

AU - Seehofer, Daniel

AU - Lynch, Stephen

AU - Samuel, Didier

AU - Ericzon, Bo-Goran

AU - Boudjema, Karim

AU - Karpf, Carmen

AU - Undre, Nasrullah

PY - 2011

Y1 - 2011

N2 - Tacrolimus, a cornerstone immunosuppressant, is available as a twice-daily formulation (tacrolimus bid). A once-daily prolonged-release formulation (tacrolimus qd) has been developed. This 6-week, randomized, phase 2, multicenter, open-label, prospective trial in primary liver transplant recipients investigated and compared the pharmacokinetics (PK) of tacrolimus for qd and bid formulations. All patients received tacrolimus-based immunosuppression (tacrolimus qd, n = 67; bid, n = 62). PK data were available for 77 patients (tacrolimus qd, n = 45; bid, n = 32). Tacrolimus area under the curve (AUC) from 0 to 24 hours (AUC(0-24) ) at equivalent doses was approximately 50% lower for tacrolimus qd than for bid on day 1 (146 versus 264 ng · h/mL, respectively), but by day 14 was comparable between treatments (324 and 287 ng · h/mL, respectively) with higher tacrolimus qd doses. There was a strong correlation between AUC(0-24) and concentration at 24 hours for tacrolimus qd and bid (r = 0.92 and r = 0.76, respectively). Furthermore, the relationship between these 2 parameters (ie, the slope of the line) was also similar for the 2 formulations. Efficacy endpoints were comparable for both formulations at 6 weeks with no marked differences in incidence, nature, or severity of adverse events between treatments (although the study was not powered to draw efficacy conclusions). These results suggest that targeting the same trough levels will achieve similar total AUC over 24 hours for both tacrolimus qd and tacrolimus bid in de novo liver transplant recipients.

AB - Tacrolimus, a cornerstone immunosuppressant, is available as a twice-daily formulation (tacrolimus bid). A once-daily prolonged-release formulation (tacrolimus qd) has been developed. This 6-week, randomized, phase 2, multicenter, open-label, prospective trial in primary liver transplant recipients investigated and compared the pharmacokinetics (PK) of tacrolimus for qd and bid formulations. All patients received tacrolimus-based immunosuppression (tacrolimus qd, n = 67; bid, n = 62). PK data were available for 77 patients (tacrolimus qd, n = 45; bid, n = 32). Tacrolimus area under the curve (AUC) from 0 to 24 hours (AUC(0-24) ) at equivalent doses was approximately 50% lower for tacrolimus qd than for bid on day 1 (146 versus 264 ng · h/mL, respectively), but by day 14 was comparable between treatments (324 and 287 ng · h/mL, respectively) with higher tacrolimus qd doses. There was a strong correlation between AUC(0-24) and concentration at 24 hours for tacrolimus qd and bid (r = 0.92 and r = 0.76, respectively). Furthermore, the relationship between these 2 parameters (ie, the slope of the line) was also similar for the 2 formulations. Efficacy endpoints were comparable for both formulations at 6 weeks with no marked differences in incidence, nature, or severity of adverse events between treatments (although the study was not powered to draw efficacy conclusions). These results suggest that targeting the same trough levels will achieve similar total AUC over 24 hours for both tacrolimus qd and tacrolimus bid in de novo liver transplant recipients.

KW - Adult

KW - Humans

KW - Male

KW - Aged

KW - Female

KW - Middle Aged

KW - Young Adult

KW - Prospective Studies

KW - Treatment Outcome

KW - Europe

KW - Kaplan-Meier Estimate

KW - Drug Administration Schedule

KW - Administration, Oral

KW - Drug Therapy, Combination

KW - Delayed-Action Preparations

KW - Australia

KW - Therapeutic Equivalency

KW - Liver Transplantation

KW - Canada

KW - Area Under Curve

KW - Graft Rejection/immunology/prevention & control

KW - Graft Survival/drug effects

KW - Immunosuppressive Agents/administration & dosage/adverse effects/pharmacokinetics

KW - Tacrolimus/administration & dosage/adverse effects/pharmacokinetics