{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T16:08:29Z","timestamp":1791821309319,"version":"4.3.4"},"reference-count":45,"publisher":"The Endocrine Society","issue":"2","license":[{"start":{"date-parts":[[2024,8,3]],"date-time":"2024-08-03T00:00:00Z","timestamp":1722643200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100012264","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100012264","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["R44NS095423"],"award-info":[{"award-number":["R44NS095423"]}],"id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["5U54HD090254"],"award-info":[{"award-number":["5U54HD090254"]}],"id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000069","name":"National","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000069","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Institute of Arthritis and Musculoskeletal and Skin Diseases","award":["U34AR068616"],"award-info":[{"award-number":["U34AR068616"]}]},{"name":"European Commission Horizons 2020","award":["667078"],"award-info":[{"award-number":["667078"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,1,21]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>Vamorolone, a novel \u201cdissociative\u201d steroid, demonstrated similar efficacy in muscle function relative to prednisone 0.75\u2005mg\/kg\/day but improved linear growth and bone turnover markers in a randomized trial of pediatric Duchenne muscular dystrophy (DMD).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To determine the frequency of adrenal suppression (AS) induced by vamorolone and prednisone in pediatric DMD and to assess cortisol thresholds using a monoclonal antibody immunoassay.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Post hoc analysis of cortisol levels was performed on data from a randomized, double-blind, placebo- and prednisone-controlled 24-week trial of vamorolone with a 24-week crossover extension. Morning and ACTH-stimulated cortisol levels were measured using the Elecsys II immunoassay, with AS defined as a stimulated cortisol of &amp;lt;500\u2005nmol\/L (\u201chistorical threshold\u201d) and &amp;lt;400\u2005nmol\/L (\u201crevised threshold\u201d).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Mean age at enrolment was 5.41 \u00b1 0.86 years (n = 118). At week 24, the proportion of participants with AS using the historical and revised cortisol thresholds, respectively, were as follows: prednisone 0.75\u2005mg\/kg\/day = 100% (25\/25) and 92.0% (23\/25); vamorolone 6\u2005mg\/kg\/day = 95.2% (20\/21) and 90.5% (19\/21); vamorolone 2\u2005mg\/kg\/day = 84.2% (16\/19) and 47.5% (9\/19); and placebo = 20.0% (4\/20) and 0% (0\/20). Morning and peak ACTH-stimulated cortisol were strongly correlated in steroid-treated boys (Spearman correlation week 48 = 0.83).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>AS after vamorolone and prednisone was frequent and vamorolone-associated AS appeared dose-dependent. A lower stimulated cortisol threshold may be appropriate when using a monoclonal assay. We recommend hydrocortisone for glucocorticoid stress dosing in patients receiving vamorolone.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgae521","type":"journal-article","created":{"date-parts":[[2024,8,4]],"date-time":"2024-08-04T03:06:16Z","timestamp":1722740776000},"page":"334-344","source":"Crossref","is-referenced-by-count":19,"title":["Adrenal Suppression From Vamorolone and Prednisone in Duchenne Muscular Dystrophy: Results From the Phase 2b Clinical Trial"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3226-8322","authenticated-orcid":false,"given":"Alexandra","family":"Ahmet","sequence":"first","affiliation":[{"name":"Division of Endocrinology, Children's Hospital of Eastern Ontario and Department of Pediatrics, University of Ottawa , Ottawa, Ontario K1H 8L1 ,","place":["Canada"]},{"name":"Children's Hospital of Eastern Ontario Research Institute , Ottawa, Ontario K1H 8L1 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