Evidence map›Paper›PMID 40377230›Full record

Trial reportClinical endocrinology2025

Switching Patients With Congenital Adrenal Hyperplasia to Modified-Release Hydrocortisone Capsules: Relative Bioavailability and Disease Control.

Richard John M Ross, Wiebke Arlt, Aude Brac de la Perriere, Angelica Lindén Hirschberg, Anders Juul, Deborah P Merke, John D C Newell-Price, Alessandro Prete, D Aled Rees, Nicole Reisch and 6 more

Abstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical endocrinology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  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

16 authors.

Richard John M RossUniversity of Sheffield, Sheffield, UK.
Wiebke ArltMRC Laboratory of Medical Sciences, London, UK.ORCID https://orcid.org/0000-0001-5106-9719
Aude Brac de la PerriereHopital Louis Pradel, Bron, France.
Angelica Lindén HirschbergKarolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-6481-6277
Anders JuulDepartment of Growth and Reproduction, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-0534-4350
Deborah P MerkeNational Institutes of Health Clinical Center and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA.ORCID https://orcid.org/0000-0002-3746-0460
John D C Newell-PriceUniversity of Sheffield, Sheffield, UK.
Alessandro PreteInstitute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0002-4821-0336
D Aled ReesCardiff University, Cardiff, UK.ORCID https://orcid.org/0000-0002-1165-9092
Nicole ReischMedizinische Klinik und Poliklinik IV, LMU Klinikum München, Munich, Germany.ORCID https://orcid.org/0000-0002-7469-6069
Monica StikkelbroeckRadboud Univ Nijmegen Med Ctr, Nijmegen, Netherlands.ORCID https://orcid.org/0000-0001-5268-9370
Philippe A TouraineHôpital Pitié Salpêtrière, Sorbonne Université, Paris, Cedex, France.ORCID https://orcid.org/0000-0002-8462-7753
Kerry MaltbyNeurocrine UK, Cardiff, UK.
Jo QuirkeNeurocrine UK, Cardiff, UK.
Helen CoopeNeurocrine UK, Cardiff, UK.ORCID https://orcid.org/0009-0008-5244-4670
John PorterNeurocrine UK, Cardiff, UK.

Funding

This study was initiated and supported by Diurnal Ltd UK (now Neurocrine UK Limited), and supported in part (through author participation) by the Intramural Research Programme of the National Institutes of Health, Bethesda, MD, USA.
6 · The paper itself

Abstract

backgroundReplacement therapy with modified-release hydrocortisone capsules (MRHC) restores the physiological circadian cortisol rhythm in congenital adrenal hyperplasia (CAH).

aimsTo determine the relative bioavailability of MRHC and evaluate an optimal protocol to switch CAH patients from standard therapy to MRHC.

methods(1): Crossover study in healthy participants comparing relative bioavailability of MRHC with immediate-release hydrocortisone (IRHC). (2): Post hoc analysis of first 4 weeks of phase 3 MRHC study when CAH patients were switched to MRHC.

resultsTwenty-four healthy male participants completed the relative bioavailability study: 20 mg MRHC showed comparable bioavailability to 20 mg IRHC tablets; mean AUC

conclusionsMRHC showed comparable bioavailability to IRHC based on cortisol AUC after 20 mg administration. Switching patients treated with IRHC to a twice daily MRHC regimen on the same daily dose (giving approximately two thirds of the dose at night) is an effective protocol for starting MRHC treatment.

Indexed as

Adrenal Hyperplasia, CongenitalHydrocortisoneAdolescentAdultBiological AvailabilityCapsulesCross-Over StudiesHumansMaleMiddle AgedYoung AdultCapsulesHydrocortisone21‐hydroxylase deficiencyadrenal insufficiencycongenital adrenal hyperplasiaglucocorticoidhydrocortisoneMRHC

Identifiers

PMID40377230
PMCPMC12319290

What OpenQuestion holds

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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.