NDLI: LCI699, a potent 11ß-hydroxylase inhibitor, normalizes urinary cortisol in patients with Cushing's disease: results from a multicenter, proof-of-concept study.

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LCI699, a potent 11ß-hydroxylase inhibitor, normalizes urinary cortisol in patients with Cushing's disease: results from a multicenter, proof-of-concept study.

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LCI699, a potent 11ß-hydroxylase inhibitor, normalizes urinary cortisol in patients with Cushing's disease: results from a multicenter, proof-of-concept study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Boscaro, Marco Fleseriu, Maria Robinson, Paul Taylor, Ann Maldonado, Mario Biller, Beverly M. K. Bertagna, Xavier Pivonello, Rosario Zhang, Yiming Hamrahian, Amir H. Watson, Catherine E.
Description	Author Affiliation: Bertagna X ( Department of Endocrinology (X.B.), Centre de Référence des Maladies Rares de la Surrénale, Hôpital Cochin, Faculté de Médecine Paris Descartes, Université Paris 5, Paris 75014, France)
Abstract	INTRODUCTION: The clinical features and increased mortality associated with Cushing's syndrome result from a chronic excess of circulating cortisol. As LCI699 potently inhibits 11ß-hydroxylase, which catalyzes the final step of cortisol synthesis, it is a potential new treatment for Cushing's disease, the most common cause of endogenous Cushing's syndrome. METHODS: Adult patients with moderate-to-severe Cushing's disease (urinary free cortisol [UFC] levels >1.5 × ULN [upper limit of normal]) received oral LCI699 for 10 weeks in this proof-of-concept study. LCI699 was initiated at 4 mg/d in two equal doses; the dose was escalated every 14 days to 10, 20, 40, and 100 mg/d until UFC normalized, whereupon the dose was maintained until treatment ended (day 70). The primary endpoint was UFC ≤ ULN or a ≥50% decrease from baseline at day 70. RESULTS: Twelve patients were enrolled and completed the study. Baseline UFC ranged over 1.6-17.0 × ULN. All 12 patients achieved UFC ≤ULN or a ≥50% decrease from baseline at day 70; 11 (92%) had normal UFC levels at that time. After treatment discontinuation (day 84), UFC was >ULN in 10 patients with available measurements. Mean 11-deoxycortisol, 11-deoxycorticosterone, and adrenocorticotropic hormone levels increased during treatment and declined after discontinuation. Mean systolic and diastolic blood pressure decreased from baseline by 10.0 and 6.0 mmHg, respectively. LCI699 was generally well tolerated; most adverse events (AEs) were mild or moderate. The most common AEs included fatigue (7/12), nausea (5/12), and headache (3/12). No serious drug-related AEs were reported. CONCLUSIONS: LCI699 was efficacious and well tolerated in patients with Cushing's disease enrolled in this proof-of-concept study.
ISSN	0021972X
e-ISSN	19457197
Journal	The Journal of Clinical Endocrinology & Metabolism
Issue Number	4
Volume Number	99
Language	English
Publisher	Oxford University Press
Publisher Date	2014-04-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Hydrocortisone Urine Imidazoles Therapeutic Use Pituitary Acth Hypersecretion Drug Therapy Pyridines Steroid 11-beta-hydroxylase Antagonists & Inhibitors Dose-response Relationship, Drug Feasibility Studies Pharmacokinetics Reference Values Urinalysis Clinical Trial Multicenter Study Research Support, Non-u.s. Gov't Discipline Endocrinology Discipline Metabolism
Content Type	Text
Resource Type	Article
Subject	Biochemistry (medical) Endocrinology, Diabetes and Metabolism Clinical Biochemistry Biochemistry Endocrinology

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