Evidence map›Paper›PMID 34452199›Full record

ArticlePharmaceutics2021

Evaluation of Pharmacokinetics and Pharmacodynamics of Deferasirox in Pediatric Patients.

Laura Galeotti, Francesco Ceccherini, Carmen Fucile, Valeria Marini, Antonello Di Paolo, Natalia Maximova, Francesca Mattioli

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04423237 (Identification of Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients Undergoing a Hematopoietic Stem Cell Transplant), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT04423237 completednot on this map

Identification of Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients Undergoing a Hematopoietic Stem Cell Transplant (HSCT)

TypeobservationalSponsorUniversity of PisaRan2020 to 2024Enrolled39ConditionsIron OverloadArmsDeferasirox
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 13 citations in OpenAlex.

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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

7 authors at 3 institutions in 1 country.

Laura GaleottiPhymtech Srl, Via F.lli Rosselli 8, San Giuliano Terme, 56127 Pisa, Italy.
Francesco CeccheriniPhymtech Srl, Via F.lli Rosselli 8, San Giuliano Terme, 56127 Pisa, Italy.
Carmen FucileDepartment of Internal Medicine, Pharmacology & Toxicology Unit, University of Genoa, 16100 Genoa, Italy.
Valeria MariniDepartment of Internal Medicine, Pharmacology & Toxicology Unit, University of Genoa, 16100 Genoa, Italy.
Antonello Di PaoloDepartment of Clinical and Experimental Medicine, Section of Pharmacology, University of Pisa, Via Roma, 55, 56126 Pisa, Italy.ORCID 0000-0002-2661-6183
Natalia MaximovaIRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health, 34137 Trieste, Italy.
Francesca MattioliDepartment of Internal Medicine, Pharmacology & Toxicology Unit, University of Genoa, 16100 Genoa, Italy.
Ente Ospedaliero Ospedali Galliera · ITIRCCS Materno Infantile Burlo Garofolo · ITUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDeferasirox (DFX) is commonly used to reduce the chronic iron overload (IO) in pediatric patients. However, the drug is characterized by a large pharmacokinetic variability and approximately 10% of patients may discontinue the treatment due to toxicities. Therefore, the present retrospective study investigated possible correlations between DFX pharmacokinetics and drug-associated toxicities in 39 children (26 males), aged 2-17 years, who underwent an allogeneic hematopoietic stem cell transplantation.

methodsIO was diagnosed by an abdominal magnetic resonance imaging and DFX was started at a median dose of 500 mg/day. DFX plasma concentrations were measured by a high performance liquid chromatographic method with UV detection and they were analysed by nonlinear mixed-effects modeling.

resultsThe pharmacometric analysis demonstrated that DFX pharmacokinetics were significantly influenced by lean body mass (bioavailability and absorption constant), body weight (volume of distribution), alanine and aspartate transaminases, direct bilirubin, and serum creatinine (clearance). Predicted DFX minimum plasma concentrations (C

conclusionsThe population pharmacokinetic model described the interindividual variability and identified C

Indexed as

childrenDeferasiroxpopulation pharmacokineticstherapeutic drug monitoringtolerability

Identifiers

PMID34452199
PMCPMC8401444
OpenAlexW3195411869

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.