Evidence map›Paper›PMID 27561267›Full record

Trial reportEuropean journal of clinical pharmacology2016

Evaluation of the pharmacokinetics of glibenclamide tablet given, off label, orally to children suffering from neonatal syndromic hyperglycemia.

Naïm Bouazza, Zoubir Djerada, Claire Gozalo, Kanetee Busiah, Jacques Beltrand, Marianne Berdugo, Saik Urien, Jean-Marc Treluyer, Michel Polak

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Experience with enteral sulfonylurea monotherapy for extremely low birth weight infants with hyperglycemia.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Naïm BouazzaEA 7323, Université Paris Descartes Sorbonne Paris Cité, Paris, France. naim.bouazza@cch.aphp.fr.
Zoubir DjeradaLaboratoire de Pharmacologie-Toxicologie, Hôpital Maison Blanche, Centre Hospitalier et Universitaire de Reims, Reims, France.
Claire GozaloLaboratoire de Pharmacologie-Toxicologie, Hôpital Maison Blanche, Centre Hospitalier et Universitaire de Reims, Reims, France.
Kanetee BusiahEndocrinologie Gynécologie Diabétologie Pédiatriques, Hôpital Universitaire Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.
Jacques BeltrandEndocrinologie Gynécologie Diabétologie Pédiatriques, Hôpital Universitaire Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.
Marianne BerdugoUniversité Paris Descartes Sorbonne Paris Cité, Institut IMAGINE, Paris, France.
Saik UrienEA 7323, Université Paris Descartes Sorbonne Paris Cité, Paris, France.
Jean-Marc TreluyerEA 7323, Université Paris Descartes Sorbonne Paris Cité, Paris, France.
Michel PolakEndocrinologie Gynécologie Diabétologie Pédiatriques, Hôpital Universitaire Necker Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.
Délégation Paris 5 · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Reims · FRHôpital Maison Blanche · FRSorbonne Paris Cité · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeGlibenclamide (Gb) is used in type II diabetes mellitus but also in the last 10 years, off label, in patients with neonatal syndromic hyperglycemia carrying a mutation of Kir6.2 or SUR1. No studies have reported Gb pharmacokinetics in children. In this study, oral Gb pharmacokinetics was investigated in children in order to describe the concentration time courses, the influence of covariates, and the relationships between drug concentrations and efficacy.

methodsGb concentrations were measured in 18 children after the switch from subcutaneous insulin to oral tablets of Gb (crushed tablets for 33 % of patients). A total of 229 plasma Gb concentrations and 187 blood glucose measurements were available. A population model was developed with NONMEM.

resultsBody weight was the most significant parameter on clearance and explained a substantial part of the variability. A variant genotype of CYP2C9 (i.e., *1/*2 and *1/*3) explained also a part of the remaining variability on Gb clearance. Patients carrying these allelic variants had a clearance decreased by 45 %. A link between daily area under the curve (AUC

conclusionsThis study evaluates for the first time the pharmacokinetics of oral Gb in children and constitutes a first step towards dose individualization of this drug in a particularly vulnerable population.

Indexed as

Models, BiologicalAdministration, OralBlood GlucoseChildChild, PreschoolCytochrome P-450 CYP2C9Dose-Response Relationship, DrugGenotypeGlyburideHumansHyperglycemiaHypoglycemic AgentsInjections, SubcutaneousInsulinKcnj11 ChannelMutationABCC8 protein, humanBlood GlucoseCYP2C9 protein, humanCytochrome P-450 CYP2C9GlyburideHypoglycemic AgentsInsulinKcnj11 ChannelPotassium Channels, Inwardly RectifyingSulfonylurea ReceptorsTabletsChildrenDiabetes mellitusGlibenclamideNeonatal diabetes mellitusNeonatal syndromic hyperglycemiaPopulation pharmacokinetics

Identifiers

PMID27561267
OpenAlexW2514087954

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.