{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T08:44:08Z","timestamp":1770453848334,"version":"3.49.0"},"reference-count":33,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T00:00:00Z","timestamp":1569888000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Endocrinology"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Many patients with Cushing's disease (CD) require chronic pharmacotherapy to control their hypercortisolism. We evaluated the efficacy and safety of long\u2010acting pasireotide during a long\u2010term extension study in patients with CD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Open\u2010label extension to a 12\u2010month Phase III study of long\u2010acting pasireotide in CD (N\u00a0=\u00a0150; NCT01374906).<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients<\/jats:title><jats:p>Patients with mean urinary free cortisol (mUFC)\u00a0\u2264\u00a0upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long\u2010acting pasireotide during the extension.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eighty\u2010one of 150 (54.0%) enrolled patients entered the extension. Median overall exposure to pasireotide at study end was 23.9\u00a0months; 39\/81 (48.1%) patients completed the extension (received\u00a0\u2265\u00a012\u00a0months\u2019 treatment during the extension and could transit to a separate pasireotide safety study). mUFC was \u2264ULN in 42\/81 (51.9%), 13\/81 (16.0%) and 43\/81 (53.1%) patients at extension baseline, month (M) 36 and last assessment. Median mUFC remained within normal limits. Median late\u2010night salivary cortisol was 2.6\u00a0\u00d7\u00a0ULN at core baseline and 1.3\u00a0\u00d7\u00a0ULN at M36. Clinical improvements were sustained over time. Forty\u2010two (51.9%) patients discontinued during the extension: 25 (30.9%) before M24 and 17 (21.0%) after M24. Hyperglycaemia\u2010related AEs occurred in 39.5% of patients. Mean fasting glucose (FPG) and glycated haemoglobin (HbA<jats:sub>1c<\/jats:sub>) were stable during the extension, with antidiabetic medication initiated\/escalated in some patients. Sixty\u2010six (81.5%) and 71 (88.9%) patients were classified as having diabetes (HbA<jats:sub>1c<\/jats:sub>\u00a0\u2265\u00a06.5%, FPG\u00a0\u2265\u00a07.0\u00a0mmol\/L, antidiabetic medication use, or history of diabetes) at extension baseline and last assessment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Long\u2010acting pasireotide provided sustained biochemical and clinical improvements, with no new safety signals emerging, supporting its use as an effective long\u2010term therapy for CD.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cen.14081","type":"journal-article","created":{"date-parts":[[2019,8,29]],"date-time":"2019-08-29T17:58:19Z","timestamp":1567101499000},"page":"776-785","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Long\u2010term efficacy and safety of once\u2010monthly pasireotide in Cushing's disease: A Phase III extension study"],"prefix":"10.1111","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9284-6289","authenticated-orcid":false,"given":"Maria","family":"Fleseriu","sequence":"first","affiliation":[{"name":"Northwest Pituitary Center Oregon Health &amp; Science University Portland OR USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan","family":"Petersenn","sequence":"additional","affiliation":[{"name":"ENDOC Center for Endocrine Tumors Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beverly M. 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