Evidence map›Paper›PMID 32839657›Full record

ArticleThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG2020

Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting.

Anne Chain, Rebecca Wrishko, Grygoriy Vasilinin, Samer Mouksassi

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00819039 (A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 36% 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.

NCT00819039 phase1completednot on this map

A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2009 to 2013Enrolled98ConditionsPostoperative Nausea and VomitingArmsAprepitant, Ondansetron
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

4 authors.

Anne Chain
Rebecca Wrishko
Grygoriy Vasilinin
Samer Mouksassi

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesAprepitant is effective for the prevention of chemotherapy-induced or postoperative nausea and vomiting (CINV/PONV). The aim of this study was to develop a population pharmacokinetic (PK) model of aprepitant in pediatric patients and to support dosing recommendations for oral aprepitant in pediatric patients at risk of CINV.

methodsA population PK model was constructed based on data from 3 clinical studies in which children (6 months to 12 years) and adolescents (12-19 years) were treated with a 3-day regimen of oral aprepitant (capsules or suspension), with or without intravenous fosaprepitant on day 1 (CINV), or a single dose of oral aprepitant (capsules or suspension; PONV). Nonlinear mixed-effects modeling was used for model development, and a stepwise covariate search determined factors influencing PK parameters. Simulations were performed to guide final dosing strategies of aprepitant in pediatric patients.

resultsThe analysis included 1326 aprepitant plasma concentrations from 147 patients. Aprepitant PK was described by a 2-compartment model with linear elimination and first-order absorption, with allometric scaling for central and peripheral clearance and volume using body weight, and a cytochrome P450 3A4 maturation component for the effect of ontogeny on systemic clearance. Simulations established that application of a weight-based (for those <12 years) and fixed-dose (for those 12-17 years) dosing regimen results in comparable exposures to those observed in adults.

conclusionsThe developed population PK model adequately described aprepitant PK across a broad pediatric population, justifying fixed (adult) dosing for adolescents and weight-based dosing of oral aprepitant for children.

Indexed as

aprepitantchemotherapy-induced nausea and vomitingCINVmodeling and simulationspediatricpharmacokineticsPK

Identifiers

PMID32839657
PMCPMC7439950
OpenAlexW3049128453

What OpenQuestion holds

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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.