Evidence map›Paper›PMID 23208323›Full record

Trial reportEuropean journal of clinical pharmacology2013

Limited sampling strategy using Bayesian estimation for estimating individual exposure of the once-daily prolonged-release formulation of tacrolimus in kidney transplant children.

Wei Zhao, Anne Maisin, Véronique Baudouin, May Fakhoury, Thomas Storme, Georges Deschênes, Evelyne Jacqz-Aigrain

Abstract readClinical Trial
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Trial report in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

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0cells of the map it votes in
8citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Wei ZhaoDepartment of Pediatric Pharmacology and Pharmacogenetics, Assistance Publique Hôpitaux de Paris (AP-HP), INSERM Clinical Investigation Center CIC9202-Hôpital Robert Debré, 48 Boulevard Sérurier, 75935 Paris Cedex 19, France. wei.zhao@rdb.aphp.fr
Anne Maisin
Véronique Baudouin
May Fakhoury
Thomas Storme
Georges Deschênes
Evelyne Jacqz-Aigrain

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA limited sampling strategy (LSS) for estimating the area under the curve (AUC) of the prolonged-release formulation of tacrolimus (tacrolimus(PR)) is not available in pediatric patients, although the method is of real benefit to children. The objective of this study was to develop and validate a reliable and clinically applicable LSS using Bayesian estimation for estimating tacrolimus(PR) AUC in pediatric kidney transplant patients

methodsThe original tacrolimus pharmacokinetic dataset consisted of 22 full profiles from 22 pediatric kidney transplant patients. The Bayesian estimation method was used to develop the LSS. External validation was performed in an independent validation group which consisted of 20 full pharmacokinetic profiles from 12 pediatric kidney transplant patients.

resultsBayesian estimator using C0h C2h and C3h gave the best predictive performance with a mean prediction error of 2.2 % in the external validation dataset. There was no correlation between the prediction error and age. The Bland-Altman analysis showed that the mean difference between the reference and Bayesian-estimated AUC0-24 was 3.5 (95 % confidence interval -3.5-10.5) ng h/mL

conclusionsA reliable and clinically applicable LSS for estimating AUC0-24 of tacrolimus(PR) was determined and validated in children. The prediction was unbiased and precise. It can be used as a routine procedure to perform AUC-based tacrolimus(PR) dosage optimization in pediatric renal transplant patients.

Indexed as

Kidney TransplantationAdolescentBayes TheoremBlood Specimen CollectionChild, PreschoolCytochrome P-450 CYP3ADelayed-Action PreparationsHumansPolymorphism, GeneticPredictive Value of TestsReproducibility of ResultsTacrolimusYoung AdultCYP3A5 protein, humanCytochrome P-450 CYP3ADelayed-Action PreparationsTacrolimus

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.