{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T17:54:11Z","timestamp":1783619651905,"version":"3.55.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"5","content-domain":{"domain":["eje.bioscientifica.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Ketoconazole (KTZ) is one of few available treatments for Cushing\u2019s syndrome (CS). Although KTZ has been associated with severe hepatotoxicity, little information is available about hepatic safety in CS. The aim of this study was to document changes in liver function in patients with CS treated with KTZ.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>An observational prospective French cohort study (Compassionate Use Programme (CUP)).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Enrolled patients were stratified into a KTZ-naive cohort and a cohort already treated by another formulation of ketoconazole (KTZ-switch cohort). Liver function markers (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, \u03b3-glutamyltransferase and bilirubin) were monitored at regular intervals. Patients with ALT\u2009&gt;\u20093\u2009\u00d7\u2009ULN (upper limit of normal), total bilirubin\u2009&gt;\u20092\u2009\u00d7\u2009ULN or both ALP\u2009&gt;\u20092\u2009\u00d7\u2009ULN and ALT\u2009&gt;\u2009ULN were considered to have liver injury.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 108 patients were analysed (47 KTZ-na\u00efve; 61 KTZ-switch). The median KTZ dose was 600\u2009mg\/day. Most abnormalities observed were asymptomatic mild increases of liver enzymes. Four patients in the KTZ-na\u00efve cohort (8.5%) and two in the KTZ-switch cohort (3.3%) developed liver injury, considered related to KTZ in three cases (all KTZ-na\u00efve in the first month of treatment). Five patients had mild liver function abnormalities at baseline and two had proven liver metastases. Two patients recovered on discontinuation of KTZ and the remaining patient died of unrelated causes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These findings highlight the need for close monitoring of liver enzymes especially during the first six months of treatment. Liver enzyme abnormalities usually occurred within four weeks were asymptomatic and could be reversed on timely discontinuation of KTZ.<\/jats:p><\/jats:sec>","DOI":"10.1530\/eje-17-0886","type":"journal-article","created":{"date-parts":[[2018,2,23]],"date-time":"2018-02-23T01:25:29Z","timestamp":1519349129000},"page":"447-458","update-policy":"https:\/\/doi.org\/10.1530\/crossmarkpolicy-1","source":"Crossref","is-referenced-by-count":53,"title":["Hepatic safety of ketoconazole in Cushing\u2019s syndrome: results of a Compassionate Use Programme in France"],"prefix":"10.1093","volume":"178","author":[{"given":"Jacques","family":"Young","sequence":"first","affiliation":[{"name":"1Univ Paris-Sud, Facult\u00e9 de M\u00e9decine Paris-Sud, Le Kremlin Bicetre, France"},{"name":"2Service d\u2019Endocrinologie et des Maladies de la Reproduction, Assistance Publique\u2013H\u00f4pitaux de Paris, H\u00f4pital Bic\u00eatre, Le Kremlin Bicetre, France"},{"name":"3INSERM U1185, Le Kremlin-Bicetre, 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