Evidence map›Paper›PMID 27641003›Full record

Trial reportBritish journal of clinical pharmacology2017

Population pharmacokinetics and dosing recommendations for the use of deferiprone in children younger than 6 years.

Francesco Bellanti, Giovanni C Del Vecchio, Maria C Putti, Aurelio Maggio, Aldo Filosa, Carlo Cosmi, Laura Mangiarini, Michael Spino, John Connelly, Adriana Ceci and 2 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 18% 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

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. How I manage children with Diamond-Blackfan anaemia.British journal of haematology · 2019
    Review
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

12 authors at 9 institutions in 5 countries.

Francesco BellantiLeiden Academic Centre for Drug Research, Leiden, The Netherlands.
Giovanni C Del VecchioPaediatric Hematology Unit, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Italy.
Maria C PuttiAzienda Ospedaliera di Padova, Italy.
Aurelio MaggioAzienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, Italy.
Aldo FilosaAzienda Ospedaliera Antonio Cardarelli, Naples, Italy.
Carlo CosmiClinica Pediatrica Università di Sassari - ASL1, Sassari, Italy.
Laura MangiariniConsorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy.
Michael SpinoApoPharma Inc., Toronto, Ontario, Canada.
John ConnellyApoPharma Inc., Toronto, Ontario, Canada.
Adriana CeciConsorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy.
Oscar Della PasquaLeiden Academic Centre for Drug Research, Leiden, The Netherlands.
Consortium DEferiprone Evaluation in Paediatrics (DEEP)
Chemopharma (Austria) · ATConsorzio per Valutazioni Biologiche e Farmacologiche · ITAzienda Ospedaliera di Padova · ITAzienda Universitaria Ospedaliera Consorziale - Policlinico Bari · ITCentre for Human Drug Research · NLOspedale Antonio Cardarelli · ITOspedale Vincenzo Cervello · ITUniversity College London · GBUniversity of Sassari · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsDespite long clinical experience with deferiprone, there is limited information on its pharmacokinetics in children aged <6 years. Here we assess the impact of developmental growth on the pharmacokinetics of deferiprone in this population using a population approach. Based on pharmacokinetic bridging concepts, we also evaluate whether the recommended doses yield appropriate systemic exposure in this group of patients.

methodsData from a study in which 18 paediatric patients were enrolled were available for the purposes of this analysis. Patients were randomised to three deferiprone dose levels (8.3, 16.7 and 33.3 mg kg

resultsA one-compartment model with first-order absorption and first-order elimination best described the pharmacokinetics of deferiprone. Drug disposition parameters were affected by body weight, with both clearance and volume increasing allometrically with size. Simulation scenarios show that comparable systemic exposure (AUC) is achieved in children and adults after similar dose levels in mg kg

conclusionsBased on the current findings, a dosing regimen of 25 mg kg

Indexed as

Child, PreschoolComputer SimulationDeferiproneDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansInfantIron Chelating AgentsMaleModels, BiologicalPyridonesSingle-Blind MethodDeferiproneIron Chelating AgentsPyridonesdeferipronedose rationalepaediatricspharmacokinetic bridgingthalassaemia

Identifiers

PMID27641003
PMCPMC5306498
OpenAlexW2522933058

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.