Evidence map›Paper›PMID 38934378›Full record

ArticleEndocrine connections2024

Comparison of modified-release hydrocortisone capsules versus prednisolone in the treatment of congenital adrenal hyperplasia.

Dafydd Aled Rees, Deborah P Merke, Wiebke Arlt, Aude Brac De La Perriere, Angelica Linden Hirschberg, Anders Juul, John Newell-Price, Alessandro Prete, Nicole Reisch, Nike M Stikkelbroeck and 5 more

Abstract read
In one paragraph

Article in Endocrine connections, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. 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

15 authors.

Dafydd Aled ReesCardiff University, Cardiff, United Kingdom.ORCID 0000-0002-1165-9092
Deborah P MerkeNational Institutes of Health Clinical Center and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, USA.
Wiebke ArltMRC LMS, London, United Kingdom.
Aude Brac De La PerriereHospices Civils de Lyon - GHE - Endocrinologie, Bron, France.
Angelica Linden HirschbergKarolinska Institute, Solna, Sweden.
Anders JuulDepartment of Growth and Reproduction, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-0534-4350
John Newell-PriceThe University of Sheffield, Sheffield, United Kingdom.
Alessandro PreteUniversity of Birmingham, Birmingham, United Kingdom.ORCID 0000-0002-4821-0336
Nicole ReischEndokrinologie, Nephrologie und weitere Sektionen - Medizinische Klinik und Poliklinik IV - Campus Innenstadt, München, Germany.ORCID 0000-0002-7469-6069
Nike M StikkelbroeckRadboud University Nijmegen, Nijmegen, Netherlands.
Philippe A TouraineUniversity Hospitals Pitié Salpêtrière - Charles Foix, Paris, France.ORCID 0000-0002-8462-7753
Alex LewisNeurocrine Biosciences Inc, London, United Kingdom.
John PorterNeurocrine Biosciences Inc, London, United Kingdom.
Helen CoopeNeurocrine Biosciences Inc, London, United Kingdom.
Richard J RossThe University of Sheffield, Sheffield, United Kingdom.ORCID 0000-0001-9222-9678

Funding

Modified-release Hydrocortisone Therapy as a Treatment for CAHZIACL090090 · CLC · CLINICAL CENTER · PI MERKE, DEBORAH · 2022 to 2025
$0k
6 · The paper itself

Abstract

Background: Prednisolone and prednisone are recommended treatment options for adults with congenital adrenal hyperplasia (CAH); however, there is no randomised comparison of prednis(ol)one with hydrocortisone. Design: Six-month open-label randomised phase 3 study and interim analysis of a single-arm extension study was the design of the study. Methods: The method of the study was hydrocortisone dose equivalent and 09:00-h 17-hydroxyprogesterone (17OHP) from 48 patients taking prednis(ol)one at baseline. Results: At baseline, the median hydrocortisone dose equivalent was 30 mg/day and 17OHP was < 36 nmol/L (3× upper limit of normal) in 56% of patients. Patients were randomised to continue prednis(ol)one or switch to modified-release hydrocortisone capsule (MRHC) at the same hydrocortisone-equivalent dose. At 4 weeks, 94% on MRHC and 71% on prednis(ol)one had 17OHP < 36 nmol/L. At 18 months in the extension study of MRHC, the median MRHC dose was 20 mg/day and 82% had 17OHP < 36 nmol/L. The per cent of patients with 17OHP < 36 nmol/L on a hydrocortisone dose equivalent ≤ 25 mg/day was greater at 18 months in the extension study on MRHC than while on prednis(ol)one at baseline: 57% vs 27%, P = 0.04. In the randomised study, no patients had an adrenal crisis on MRHC and one on prednisolone. In the extension study (221 patient years), there were 12 adrenal crises in 5 patients (5.4/100 patient years). Conclusion: MRHC reduces 17OHP at 09:00 h compared to prednis(ol)one and the dose of MRHC can be down-titrated over time in the majority of patients.

Indexed as

adrenal insufficiencyCAHcongenital adrenal hyperplasiacortisolhydrocortisoneprednisoloneprednisone

Identifiers

PMID38934378
PMCPMC11301537

What Socratic 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 Socratic graph.