作者
Rosario Pivonello, Maria Fleseriu, John Newell-Price, Xavier Bertagna, James Findling, Akira Shimatsu, Feng Gu, Richard Auchus, Rattana Leelawattana, Eun Jig Lee, Jung Hee Kim, André Lacroix, Audrey Laplanche, Paul O'Connell, Libuse Tauchmanova, Alberto M Pedroncelli, Beverly MK Biller
发表日期
2020/9/1
期刊
The Lancet Diabetes & Endocrinology
卷号
8
期号
9
页码范围
748-761
出版商
Elsevier
简介
Background
Cushing's disease is a rare endocrine disorder characterised by cortisol overproduction with severe complications. Therapies for cortisol reduction are often necessary. Here we report the outcomes from the pivotal phase III study of osilodrostat (a potent oral inhibitor of cytochrome P450 11B1, mitochondrial [11β-hydroxylase]; Novartis Pharma AG, Basel, Switzerland) in patients with Cushing's disease.
Methods
LINC 3 was a prospective, multicentre, open-label, phase III study with a double-blind randomised withdrawal period, that comprised four periods. Patients aged 18–75 years, with confirmed persistent or recurrent Cushing's disease (defined as mean 24-h urinary free cortisol [UFC] concentration >1·5 times the upper limit of normal [ULN] and morning plasma adrenocorticotropic hormone above the lower limit of normal) who had previously had pituitary surgery or irradiation, or were newly …
引用总数
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