Findling, J.W., Fleseriu, M., Newell-Price, J. et al. (5 more authors) (2016) Late-night salivary cortisol may be valuable for assessing treatment response in patients with Cushing’s disease: 12-month, Phase III pasireotide study. Endocrine, 54 (2). pp. 516-523. ISSN 1355-008X
Abstract
Measuring salivary cortisol is a simple, convenient and accurate technique with potential value in monitoring patients with hypercortisolism. This analysis reports changes in late-night salivary cortisol (LNSC) during a 12-month, multicentre, Phase III study of patients with Cushing’s disease who were randomized to pasireotide 600 or 900 lg sc bid. LNSC assessment was an exploratory objective based on a single, optional measurement at midnight ± 1 h on the same day as one of the 24-h urinary free cortisol (UFC) measurements. Of 162 enrolled patients, baseline LNSC was measured in 93. Sixty-seven patients had levels above the upper limit of normal (ULN); median baseline levels were 19.7 and 20.7 nmol/L in the groups subsequently randomized to 600 lg (n = 40) and 900 lg (n = 27), respectively. Median LNSC levels decreased from baseline to month 12; median changes in patients who had baseline LNSC [ULN in the 600 and 900 lg groups were -13.4 nmol/L (–52.6 %; n = 19) and -11.8 nmol/L (–56.1 %; n = 14), respectively. LNSC normalized at months 6 and 12 in 25/67 (37.3 %) and 13/67 (19.4 %) patients, respectively; 10/25 and 8/13 patients also had normalized UFC, and 7/25 and 4/13 had partial UFC control (UFC [ULN and C50 % decrease from baseline). There was a moderate correlation (r = 0.55) on the log scale between individual patient LNSC and UFC values when all time points were pooled. Pasireotide decreased LNSC levels during 12 months of treatment. Salivary cortisol may be a simple, convenient biomarker for assessing treatment response in patients with Cushing’s disease.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2016. This article is published with open access at Springerlink.com |
Keywords: | Pasireotide; Cushing’s disease; Salivary cortisol; Urinary free cortisol |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Human Metabolism (Sheffield) The University of Sheffield > Sheffield Teaching Hospitals |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 06 Jul 2016 09:33 |
Last Modified: | 24 Nov 2016 16:53 |
Published Version: | http://dx.doi.org/10.1007/s12020-016-0978-6 |
Status: | Published |
Publisher: | Humana Press |
Refereed: | Yes |
Identification Number: | 10.1007/s12020-016-0978-6 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:101612 |