Evidence map›Paper›PMID 34064165›Full record

ArticlePharmaceutics2021

Modelling Hydrocortisone Pharmacokinetics on a Subcutaneous Pulsatile Infusion Replacement Strategy in Patients with Adrenocortical Insufficiency.

Ioannis G Violaris, Konstantinos Kalafatakis, Eder Zavala, Ioannis G Tsoulos, Theodoros Lampros, Stafford L Lightman, Markos G Tsipouras, Nikolaos Giannakeas, Alexandros Tzallas, Georgina M Russell

Open 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. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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, 4 citations in OpenAlex.

  1. Review
  2. 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

10 authors at 4 institutions in 2 countries.

Ioannis G ViolarisDepartment of Electrical and Computer Engineering, University of Western Macedonia, 50131 Kozani, Greece.
Konstantinos KalafatakisLaboratories of Integrative Neuroscience and Endocrinology, School of Clinical Sciences, University of Bristol, Bristol BS1 3NY, UK.
Eder ZavalaCentre for Systems Modelling and Quantitative Biomedicine, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.ORCID 0000-0002-5467-6036
Ioannis G TsoulosDepartment of Informatics & Telecommunications, School of Informatics & Telecommunications, University of Ioannina, 47100 Arta, Greece.
Theodoros LamprosDepartment of Informatics & Telecommunications, School of Informatics & Telecommunications, University of Ioannina, 47100 Arta, Greece.
Stafford L LightmanLaboratories of Integrative Neuroscience and Endocrinology, School of Clinical Sciences, University of Bristol, Bristol BS1 3NY, UK.
Markos G TsipourasDepartment of Electrical and Computer Engineering, University of Western Macedonia, 50131 Kozani, Greece.ORCID 0000-0002-6757-1698
Nikolaos GiannakeasDepartment of Informatics & Telecommunications, School of Informatics & Telecommunications, University of Ioannina, 47100 Arta, Greece.ORCID 0000-0002-0615-783X
Alexandros TzallasDepartment of Informatics & Telecommunications, School of Informatics & Telecommunications, University of Ioannina, 47100 Arta, Greece.ORCID 0000-0001-9043-1290
Georgina M RussellLaboratories of Integrative Neuroscience and Endocrinology, School of Clinical Sciences, University of Bristol, Bristol BS1 3NY, UK.ORCID 0000-0002-1299-4116
University of Ioannina · GRUniversity of Bristol · GBUniversity of Western Macedonia · GRUniversity of Birmingham · GB

Funding

Bodossaki Foundation Α.Π. 8/366/εδMedical Research Council MR/P014747/1
6 · The paper itself

Abstract

In the context of glucocorticoid (GC) therapeutics, recent studies have utilised a subcutaneous hydrocortisone (HC) infusion pump programmed to deliver multiple HC pulses throughout the day, with the purpose of restoring normal circadian and ultradian GC rhythmicity. A key challenge for the advancement of novel HC replacement therapies is the calibration of infusion pumps against cortisol levels measured in blood. However, repeated blood sampling sessions are enormously labour-intensive for both examiners and examinees. These sessions also have a cost, are time consuming and are occasionally unfeasible. To address this, we developed a pharmacokinetic model approximating the values of plasma cortisol levels at any point of the day from a limited number of plasma cortisol measurements. The model was validated using the plasma cortisol profiles of 9 subjects with disrupted endogenous GC synthetic capacity. The model accurately predicted plasma cortisol levels (mean absolute percentage error of 14%) when only four plasma cortisol measurements were provided. Although our model did not predict GC dynamics when HC was administered in a way other than subcutaneously or in individuals whose endogenous capacity to produce GCs is intact, it was found to successfully be used to support clinical trials (or practice) involving subcutaneous HC delivery in patients with reduced endogenous capacity to synthesize GCs.

Indexed as

glucocorticoid insufficiencyglucocorticoid pulsatilityhydrocortisone replacement therapypharmacokinetic modelsubcutaneous delivery

Identifiers

PMID34064165
PMCPMC8224376
OpenAlexW3160287270

What OpenQuestion 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 OpenQuestion graph.