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These studies aimed to characterize coagulation markers at baseline in patients with CS and the impact of relacorilant or remission post-surgery in an open-label, phase 2 study (NCT02804750) and a retrospective, longitudinal, surgical cohort study.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>In the relacorilant study, 34 patients received relacorilant (100\u2013200\u00a0mg\/day for up to 12\u00a0weeks or 250\u2013400\u00a0mg\/day for up to 16\u00a0weeks) and had postbaseline data. Coagulation markers were assessed before and during treatment. In the surgical study, conducted at \u201cFederico II\u201d University of Naples, Italy, coagulation markers were assessed in 30 patients before surgery and after biochemical remission.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>In the relacorilant study, significant mean changes from baseline to last observed visit were reported in factor VIII (\u2212 18.9%, <jats:italic>P<\/jats:italic>\u2009=\u20090.022), activated partial thromboplastin time (aPTT) (+\u20091.5\u00a0s, <jats:italic>P<\/jats:italic>\u2009=\u20090.046), and platelet count (\u2212 68.8*10<jats:sup>9<\/jats:sup>\/L, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001), whereas von Willebrand factor was unchanged. In the surgical study, the mean time to hemostasis assessment was 6.2\u00a0months. Significant mean changes from baseline to hemostasis assessment were reported in factor VIII (\u2212 24.2%, <jats:italic>P<\/jats:italic>\u2009=\u20090.044), von Willebrand factor (\u2212 20.6%, <jats:italic>P<\/jats:italic>\u2009=\u20090.018), and aPTT (+\u20092.0\u00a0s, <jats:italic>P<\/jats:italic>\u2009=\u20090.031), whereas platelet count was unchanged.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Several coagulation markers improved in patients with CS after 3\u20134\u00a0months of relacorilant treatment and within an average of 6\u00a0months after surgery. Relacorilant\u2019s positive effects on coagulation markers support further investigation of its use preoperatively in patients with CS or in patients who are not eligible for surgery.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical Trial Registration Number<\/jats:title>\n            <jats:p>NCT0280475 (registration date: 15 June 2016).<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s40618-024-02468-2","type":"journal-article","created":{"date-parts":[[2024,9,21]],"date-time":"2024-09-21T09:01:41Z","timestamp":1726909301000},"page":"671-680","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Relacorilant or surgery improved hemostatic markers in Cushing syndrome"],"prefix":"10.1007","volume":"48","author":[{"given":"C.","family":"Simeoli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Di Paola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Stigliano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Lardo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Kearney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Mezosi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Ghigo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Giordano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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Eur J Endocrinol 178(4):399\u2013409","journal-title":"Eur J Endocrinol"}],"container-title":["Journal of Endocrinological Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40618-024-02468-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40618-024-02468-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40618-024-02468-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T10:49:50Z","timestamp":1740998990000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40618-024-02468-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,21]]},"references-count":41,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2025,3]]}},"alternative-id":["2468"],"URL":"https:\/\/doi.org\/10.1007\/s40618-024-02468-2","relation":{},"ISSN":["1720-8386"],"issn-type":[{"value":"1720-8386","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,21]]},"assertion":[{"value":"19 April 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 September 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 September 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"CS received occasional consulting honoraria from BresMed and Recordati. NDP, AS, PL, EG, and RG have nothing to declare. TK received other financial or non-financial interests from Corcept Therapeutics. EM was an investigator for a clinical trial of relacorilant for Corcept Therapeutics and served as a speaker for IBSA, Ipsen, Pfizer, Merck, Novartis, and Recordati. CNM received research support from Corcept Therapeutics. DMD participated in an advisory board for Amryt and Corcept Therapeutics. RAF reports research grants from Corcept Therapeutics; has served as a speaker for HRA Pharma; and consulted and served as a speaker for Recordati. ALH is an employee of Corcept Therapeutics and has stock ownership\/options in Corcept Therapeutics. AGM and KAA are employees of Corcept Therapeutics. RP has received research funding from Recordati AG., Corcept Therapeutics, StrongbridgeBiopharma, Neurocrine Biosciences; and served as a consultant for Corcept, Therapeutics, Recordati A., Crinetics Pharmaceuticals, H. Lundbeck A\/S.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The relacorilant study was reviewed and approved by the institutional review board (IRB) at each study center and was conducted in accordance with the World Medical Association Declaration of Helsinki and the International Council on Harmonisation Good Clinical Practice guidelines.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"Written informed consent was obtained from each patient prior to participation. Per institutional guidelines, as a retrospective chart review, the surgical study did not require IRB approval. However, written informed consent with respect to the confidentiality of data collection according to the Italian privacy policy was obtained and recorded in each medical chart at the time of coagulation marker evaluation.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}