Evidence map›Paper›PMID 28819726›Full record

Observational studyClinical pharmacokinetics2018

Population Pharmacokinetics of Stiripentol in Paediatric Patients with Dravet Syndrome Treated with Stiripentol, Valproate and Clobazam Combination Therapy.

Sophie Peigné, Stéphanie Chhun, Michel Tod, Elisabeth Rey, Christelle Rodrigues, Catherine Chiron, Gérard Pons, Vincent Jullien

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
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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

8 authors at 2 institutions in 1 country.

Sophie PeignéINSERM U1129, Paris, France.
Stéphanie ChhunINSERM U1129, Paris, France.
Michel TodDépartement de Physiologie-Pharmacologie-Toxicologie, Faculté de Pharmacie, Université Lyon I, Lyon, France.
Elisabeth ReyINSERM U1129, Paris, France.
Christelle RodriguesINSERM U1129, Paris, France.
Catherine ChironINSERM U1129, Paris, France.
Gérard PonsINSERM U1129, Paris, France.
Vincent JullienINSERM U1129, Paris, France. vincent.jullien@aphp.fr.ORCID 0000-0002-5971-6316
Délégation Paris 5 · FRUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim of this study was to describe the pharmacokinetics of stiripentol in children with Dravet syndrome and to determine the concentrations of stiripentol achieved in this population for the usual 25 mg/kg twice-daily dose.

methodsThirty-five children with epilepsy were included in a prospective population pharmacokinetic study (using MONOLIX software). Four blood samples were drawn per patient. Stiripentol area under the plasma concentration-time curve (AUC) values and trough concentrations were simulated for 7000 theoretical children weighing between 10 and 70 kg for the 25 mg/kg twice-daily dose.

resultsThe pharmacokinetics of stiripentol was described using a one-compartment model with zero-order absorption and first-order elimination. The apparent clearance (CL/F) and apparent volume of distribution (V

conclusionThis population pharmacokinetic model of stiripentol in children with Dravet syndrome confirmed the dose-dependent non-linearity that has been evidenced in adults. It also supported that a 25 mg/kg twice-daily dose might lead to excessive exposure in children >30 kg, suggesting an eventual dose adjustment during adolescence. CLINICAL TRIAL IDENTIFIER: This study is part of the STIPOP study (EUDRACT number: 2007-001784-30).

Indexed as

Models, BiologicalAdolescentAnticonvulsantsChildChild, PreschoolClobazamCytochrome P-450 CYP2C19DioxolanesDrug Therapy, CombinationEpilepsies, MyoclonicFemaleGenotypeHumansInfantMaleValproic AcidAnticonvulsantsClobazamCYP2C19 protein, humanCytochrome P-450 CYP2C19DioxolanesstiripentolValproic Acid

Identifiers

PMID28819726
OpenAlexW2747998075

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.