Evidence map›Paper›PMID 36986563›Full record

ArticlePharmaceuticals (Basel, Switzerland)2023

Model-Informed Target Morning 17α-Hydroxyprogesterone Concentrations in Dried Blood Spots for Pediatric Congenital Adrenal Hyperplasia Patients.

Viktoria Stachanow, Uta Neumann, Oliver Blankenstein, Nele Alder-Baerens, Davide Bindellini, Peter Hindmarsh, Richard J Ross, Martin J Whitaker, Johanna Melin, Wilhelm Huisinga and 2 more

Open access · goldAbstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Development of Medicines for Rare Pediatric Diseases.Pharmaceuticals (Basel, Switzerland) · 2023
    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

12 authors at 5 institutions in 2 countries.

Viktoria StachanowDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169 Berlin, Germany.ORCID 0000-0003-0018-4623
Uta NeumannCharité-Universitätsmedizin, Freie Universität Berlin, 13353 Berlin, Germany.
Oliver BlankensteinCharité-Universitätsmedizin, Freie Universität Berlin, 13353 Berlin, Germany.ORCID 0000-0003-1803-5589
Nele Alder-BaerensLabor Berlin, Charité Vivantes GmbH, 13353 Berlin, Germany.
Davide BindelliniDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169 Berlin, Germany.
Peter HindmarshDevelopmental Endocrinology Research Group, UCL Institute of Child Health, London WC1E 6BT, UK.
Richard J RossDepartment of Oncology and Metabolism, University of Sheffield, Sheffield S10 2TN, UK.
Martin J WhitakerDepartment of Oncology and Metabolism, University of Sheffield, Sheffield S10 2TN, UK.ORCID 0000-0003-2388-4753
Johanna MelinDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169 Berlin, Germany.
Wilhelm HuisingaInstitute of Mathematics, Universität Potsdam, 14476 Potsdam, Germany.ORCID 0000-0002-5249-3914
Robin MicheletDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169 Berlin, Germany.ORCID 0000-0002-5485-607X
Charlotte KloftDepartment of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Kelchstr 31, 12169 Berlin, Germany.
Freie Universität Berlin · DEUniversity of Sheffield · GBVivantes Klinikum · DEUniversity College London · GBUniversity of Potsdam · DE

Funding

Diurnal (United Kingdom) The work was carried out under a Cooperation Agreement between Freie Universitaet and Di-urnal funded by Diurnal Ltd.
6 · The paper itself

Abstract

Monitoring cortisol replacement therapy in congenital adrenal hyperplasia (CAH) patients is vital to avoid serious adverse events such as adrenal crises due to cortisol underexposure or metabolic consequences due to cortisol overexposure. The less invasive dried blood spot (DBS) sampling is an advantageous alternative to traditional plasma sampling, especially in pediatric patients. However, target concentrations for important disease biomarkers such as 17α-hydroxyprogesterone (17-OHP) are unknown using DBS. Therefore, a modeling and simulation framework, including a pharmacokinetic/pharmacodynamic model linking plasma cortisol concentrations to DBS 17-OHP concentrations, was used to derive a target morning DBS 17-OHP concentration range of 2-8 nmol/L in pediatric CAH patients. Since either capillary or venous DBS sampling is becoming more common in the clinics, the clinical applicability of this work was shown by demonstrating the comparability of capillary and venous cortisol and 17-OHP concentrations collected by DBS sampling, using a Bland-Altman and Passing-Bablok analysis. The derived target morning DBS 17-OHP concentration range is a first step towards providing improved therapy monitoring using DBS sampling and adjusting hydrocortisone (synthetic cortisol) dosing in children with CAH. In the future, this framework can be used to assess further research questions, e.g., target replacement ranges for the entire day.

Indexed as

17α-hydroxyprogesteronecongenital adrenal hyperplasiadried blood spotspediatricspharmacometricstarget concentration range

Identifiers

PMID36986563
PMCPMC10051286
OpenAlexW4328100131

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.