{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T14:15:30Z","timestamp":1793196930625,"version":"4.5.0"},"reference-count":71,"publisher":"The Endocrine Society","issue":"12","license":[{"start":{"date-parts":[[2025,4,2]],"date-time":"2025-04-02T00:00:00Z","timestamp":1743552000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Union\u2014NextGenerationEU"},{"DOI":"10.13039\/501100003407","name":"Italian Ministry of University and Research","doi-asserted-by":"publisher","award":["PNRR - M4C2-I1.3"],"award-info":[{"award-number":["PNRR - M4C2-I1.3"]}],"id":[{"id":"10.13039\/501100003407","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002862","name":"CUP","doi-asserted-by":"publisher","award":["B53C22004000006"],"award-info":[{"award-number":["B53C22004000006"]}],"id":[{"id":"10.13039\/501100002862","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Ministerial Research Project","award":["PRIN PNRR Prot. P2022EA9RR_001"],"award-info":[{"award-number":["PRIN PNRR Prot. P2022EA9RR_001"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Medical therapy for Cushing syndrome (CS) typically aims to reduce daily cortisol output without addressing circadian rhythm restoration. No licensed drugs target this goal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We investigated the efficacy and safety of timed, once-daily osilodrostat administration in improving circadian cortisol profiles in CS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A prospective, multicenter study evaluated patients with well-controlled CS on a stable twice-daily osilodrostat therapy before and 60 to 90 days after transitioning to a single equivalent daily dose at 19:00 \u00b1 1 hour. Circadian steroid analysis was performed on saliva, serum, and urine using ultra-high performance liquid chromatography\u2013tandem mass spectrometry. Additional assessments included cardio-metabolic markers, quality of life, sleep function, and safety outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixteen patients (4 males; 7 pituitary, mean age 53.3 \u00b1 11.8 years) were enrolled. At baseline, CS was well-controlled with a mean osilodrostat dose of 4.2 \u00b1 1.3\u2005mg. After transitioning, salivary cortisol exposure decreased significantly during the afternoon to early morning period (AUC16:00-08:00: \u22126.1 [\u22120.15 to \u221212.1] ng\/mL\/h, P = .029). Quality of life and sleep improved (CushingQoL: +4.2, P = .029; Pittsburgh Sleep Quality Index: \u22121.7, P = .049). Serum steroid precursors, including 11-deoxycorticosterone (\u22123.1\u2005ng\/mL\/h, P = .008) and 11-deoxycortisol (\u221217.8\u2005ng\/mL\/h, P = .005), decreased. Eight patients advancing dosing to 16:00 \u00b1 1 hour showed comparable reductions, with phase shifts in acrophase and nadir. No patients developed adrenal insufficiency, liver toxicity, electrocardiogram abnormalities, or loss of disease control.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Once-daily osilodrostat effectively and safely treats patients with biochemically controlled CS, improving circadian cortisol profiles, quality of life, and sleep. Findings support further exploration of chronotherapy-based approaches in CS management.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgaf206","type":"journal-article","created":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T07:52:04Z","timestamp":1743493924000},"page":"3525-3537","source":"Crossref","is-referenced-by-count":30,"title":["Chronotherapy With Once-Daily Osilodrostat Improves Cortisol Rhythm, Quality of Life, and Sleep in Cushing's Syndrome"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-3803-4350","authenticated-orcid":false,"given":"Davide","family":"Ferrari","sequence":"first","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilaria","family":"Bonaventura","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Simeoli","sequence":"additional","affiliation":[{"name":"Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Diabetologia, Andrologia e Nutrizione, Universit\u00e0 Federico II di Napoli , Naples 80131 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Tomaselli","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludovica","family":"Vincenzi","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5242-1761","authenticated-orcid":false,"given":"Dario","family":"De Alcubierre","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Sciarra","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavio","family":"Rizzo","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Cerroni","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Di Paola","sequence":"additional","affiliation":[{"name":"Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Diabetologia, Andrologia e Nutrizione, Universit\u00e0 Federico II di Napoli , Naples 80131 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9091-2809","authenticated-orcid":false,"given":"Marianna","family":"Minnetti","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2220-9783","authenticated-orcid":false,"given":"Emilia","family":"Sbardella","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Anna","family":"Venneri","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, \u201cSapienza\u201d University of Rome , Rome 00161 ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo","family":"Pofi","sequence":"additional","affiliation":[{"name":"Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital , Oxford OX3 7LE 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