Evidence map›Paper›PMID 32326156›Full record

ArticlePharmaceutics2020

Real Life Population Pharmacokinetics Modelling of Eight Factors VIII in Patients with Severe Haemophilia A: Is It Always Relevant to Switch to an Extended Half-Life?

Quentin Allard, Zoubir Djerada, Claire Pouplard, Yohann Repessé, Dominique Desprez, Hubert Galinat, Birgit Frotscher, Claire Berger, Annie Harroche, Anne Ryman and 7 more

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

9 citing papers in PubMed, 17 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

17 authors at 13 institutions in 1 country.

Quentin AllardDepartment of Medical Pharmacology, University Hospital of Reims, EA3801, SFR Cap-Santé, University of Reims, 51100 Reims, France.ORCID 0000-0003-1052-5524
Zoubir DjeradaDepartment of Medical Pharmacology, University Hospital of Reims, EA3801, SFR Cap-Santé, University of Reims, 51100 Reims, France.ORCID 0000-0002-4022-7889
Claire PouplardDepartment of Haemostasis, University Hospital of Tours, 37000 Tours, France.
Yohann RepesséDepartment of Haemostasis, University Hospital of Caen, 14000 Caen, France.
Dominique DesprezDepartment of Haemostasis, University Hospital of Strasbourg, 67000 Strasbourg, France.
Hubert GalinatDepartment of Haemostasis, University Hospital of Brest, 29200 Brest, France.
Birgit FrotscherDepartment of Haemostasis, University Hospital of Nancy, 54000 Nancy, France.
Claire BergerDepartment of Haemostasis, University Hospital of Saint-Etienne, 42000 Saint-Etienne, France.ORCID 0000-0001-9875-5150
Annie HarrocheDepartment of Haemostasis, Hospital Necker, Assistance Publique-Hôpitaux de Paris, 75015 Paris, France.
Anne RymanDepartment of Haemostasis, University Hospital of Bordeaux, 33000 Bordeaux, France.
Claire FlaujacDepartment of Haemostasis, Hospital of Versailles, 78000 Versailles, France.
Pierre ChamouniDepartment of Haemostasis, University Hospital of Rouen, 76000 Rouen, France.
Benoît GuilletDepartment of Haemostasis, University Hospital of Rennes, 35000 Rennes, France.
Fabienne VolotDepartment of Haemostasis, University Hospital of Dijon, 21000 Dijon, France.
Jean SzymezakDepartment of Haemostasis, University Hospital of Reims, EA3801, SFR Cap-Santé, University of Reims, 51100 Reims, France.
Philippe NguyenDepartment of Haemostasis, University Hospital of Reims, EA3801, SFR Cap-Santé, University of Reims, 51100 Reims, France.
Yoann CazaubonDepartment of Medical Pharmacology, University Hospital of Reims, EA3801, SFR Cap-Santé, University of Reims, 51100 Reims, France.ORCID 0000-0003-1032-0879
Centre Hospitalier Universitaire de Reims · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier de Versailles · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Régional Universitaire de Brest · FRCentre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire de Saint-Étienne · FRMaison des Sciences sociales et des Humanités de Dijon · FRUniversité de Bordeaux · FRUniversité de Caen Normandie · FRUniversité de Rouen Normandie · FRUniversité de Strasbourg · FRUniversité de Tours · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We retrospectively analysed the data files of 171 adults and 87 children/adolescents with severe haemophilia, except for 14 patients (moderate; minor) (1), to develop a global population pharmacokinetic (PK) model for eight factors VIII (FVIII) that could estimate individual PK parameters for targeting the desired level of FVIII activity (FVIII:C); and (2) to compare half-life (HL) in patients switching from a standard half-life (SHL) to an extended half-life (EHL) and evaluate the relevance of the switch. One-stage clotting assay for the measurement of FVIII activity (FVIII:C, IU/mL) was used for population PK modelling. The software, Monolix version 2019R1, was used for non-linear mixed-effects modelling. A linear two-compartment model best described FVIII:C. The estimated PK parameters (between-subject variability) were: 2640 mL (23.2%) for volume of central compartment (V1), 339 mL (46.8%) for volume of peripheral compartment (V2), 135 mL/h for Q (fixed random effect), and 204 mL/h (34.9%) for clearance (Cl). Weight, age, and categorical covariate EHL were found to influence Cl and only weight for V1. This model can be used for all of the FVIII cited in the study. Moreover, we demonstrated, in accordance with previous studies, that Elocta had longer half-life (EHL) than SHL (mean ratio: 1.48) as compared to Advate, Factane, Kogenate, Novoeight, and Refacto.

Indexed as

dose tailoringfactor VIIImodellingpharmacokineticssevere haemophilia Aswitch

Identifiers

PMID32326156
PMCPMC7238177
OpenAlexW3017804820

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.