Evidence map›Paper›PMID 38955947›Full record

ArticleClinical pharmacokinetics2024

Characterizing Enoxaparin's Population Pharmacokinetics to Guide Dose Individualization in the Pediatric Population.

Fernando O Carreño, Jacqueline G Gerhart, Victória E Helfer, Jaydeep Sinha, Karan R Kumar, Carl Kirkpatrick, Christoph P Hornik, Daniel Gonzalez, Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee

Abstract read
In one paragraph

Article in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Evaluation of Enoxaparin Dosing in Infants Greater Than 2 to 6 Months of Age, a Pre and Post Quasi Experiment.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Protein C concentrate pharmacokinetics-no need to fear the curve.Research and practice in thrombosis and haemostasis · 2025
    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.

Fernando O CarreñoDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-4921-5235
Jacqueline G GerhartDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0003-4679-4638
Victória E HelferDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-6681-9356
Jaydeep SinhaDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-2110-3370
Karan R KumarDuke Clinical Research Institute, PO Box 17969, Durham, NC, 27715, USA.ORCID 0000-0001-9196-6350
Carl KirkpatrickMonash Institute of Pharmaceutical Sciences, Monash University, Victoria, Australia.ORCID 0000-0002-5715-1534
Christoph P HornikDuke Clinical Research Institute, PO Box 17969, Durham, NC, 27715, USA.ORCID 0000-0001-7056-8759
Daniel GonzalezDuke Clinical Research Institute, PO Box 17969, Durham, NC, 27715, USA. daniel.gonzalez@duke.edu.ORCID 0000-0001-5522-5686
Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee

Funding

Application of Physiologically-Based Pharmacokinetic Modeling to Characterize Drug-Drug Interactions in InfantsR01HD102949 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Daniel Gonzalez · 2021 to 2026
$3.0M
Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with ObesityR01HD096435 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DUMOND, JULIE BRUMER · 2018 to 2022
$2.0M
Enhancement Training for the Next Generation of Translational Ph.D. ScientistsT32GM122741 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WOLBERG, ALISA S., YEH, JEN JEN · 2018 to 2022
$898k
Eunice Kennedy Shriver National Institute of Child Health and Human Development 5R01HD096435NICHD NIH HHS HHSN275201000003INICHD NIH HHS R01 HD096435NICHD NIH HHS R01 HD102949NIGMS NIH HHS T32 GM122741
6 · The paper itself

Abstract

BACKGROUND AND

objectivePediatric dosing of enoxaparin was derived based on extrapolation of the adult therapeutic range to children. However, a large fraction of children do not achieve therapeutic anticoagulation with initial dosing. We aim to use real-world anti-Xa data obtained from children receiving enoxaparin per standard of care to characterize the population pharmacokinetics (PopPK)

methodsA PopPK analysis was performed using NONMEM, and a stepwise covariate modeling approach was applied for the covariate selection. The final PopPK model, developed with data from 1293 patients ranging in age from 1 day to 18 years, was used to simulate enoxaparin subcutaneous dosing for prophylaxis and treatment based on total body weight (0-18 years, TBW) or fat-free mass (2-18 years, FFM). Simulated exposures in children with obesity (body mass index percentile ≥95th percentile) were compared with those without obesity.

resultsA linear, one-compartment PopPK model that included allometric scaling using TBW (<2 years) or FFM (≥2 years) characterized the enoxaparin pharmacokinetic data. In addition, serum creatinine was identified as a significant covariate influencing clearance. Simulations indicated that in patients aged <2 years, the recommended 1.5 mg/kg TBW-based dosing achieves therapeutic simulated concentrations. In pediatric patients aged ≥2 years, the recommended 1.0 mg/kg dose resulted in exposures more comparable in children with and without obesity when FFM weight-based dosing was applied.

conclusionUsing real-world data and PopPK modeling, enoxaparin's pharmacokinetics were characterized in pediatric patients. Using FFM and twice-daily dosing might reduce the risk of overdosing, especially in children with obesity.

Indexed as

AnticoagulantsEnoxaparinModels, BiologicalAdolescentBody WeightChildChild, PreschoolDose-Response Relationship, DrugFemaleHumansInfantInfant, NewbornMalePrecision MedicineAnticoagulantsEnoxaparin

Identifiers

PMID38955947
PMCPMC11288483

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Registered trials

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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.