@article{0cb1e209563a488d8297b95fe971f0f8,
title = "Use of late-night salivary cortisol to monitor response to medical treatment in Cushing{\textquoteright}s disease",
abstract = "Objective: Monitoring of patients with Cushing{\textquoteright}s disease on cortisol-lowering drugs is usually performed with urinary free cortisol (UFC). Late-night salivary cortisol (LNSC) has an established role in screening for hypercortisolism and can help to detect the loss of cortisol circadian rhythm. Less evidence exists regarding the usefulness of LNSC in monitoring pharmacological response in Cushing{\textquoteright}s disease. Design: Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing{\textquoteright}s disease (clinicaltrials.gov: NCT01374906). Methods: Mean LNSC (mLNSC) was calculated from two samples, collected on the same days as the first two of three 24-h urine samples (used to calculate mean UFC [mUFC]). Clinical signs of hypercortisolism were evaluated over time. Results: At baseline, 137 patients had evaluable mLNSC measurements; 91.2% had mLNSC exceeding the upper limit of normal (ULN; 3.2 nmol/L). Of patients with evaluable assessments at month 12 (n = 92), 17.4% had both mLNSC ≤ULN and mUFC ≤ULN; 22.8% had mLNSC ≤ULN, and 45.7% had mUFC ≤ULN. There was high variability in LNSC (intra-patient coefficient of variation (CV): 49.4%) and UFC (intra-patient CV: 39.2%). mLNSC levels decreased over 12 months of treatment and paralleled changes in mUFC. Moderate correlation was seen between mLNSC and mUFC (Spearman{\textquoteright}s correlation: ρ = 0.50 [all time points pooled]). Greater improvements in systolic/diastolic blood pressure and weight were seen in patients with both mLNSC ≤ULN and mUFC ≤ULN. Conclusion: mUFC and mLNSC are complementary measurements for monitoring treatment response in Cushing{\textquoteright}s disease, with better clinical outcomes seen for patients in whom both mUFC and mLNSC are controlled.",
author = "John Newell-Price and Rosario Pivonello and Antoine Tabarin and Maria Fleseriu and Przemys{\l}aw Witek and Gadelha, {M{\^o}nica R.} and Stephan Petersenn and Libuse Tauchmanova and Shoba Ravichandran and Pritam Gupta and Andr{\'e} Lacroix and Biller, {Beverly M.K.}",
note = "Funding Information: This study was sponsored by Novartis Pharma AG. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation. Funding Information: of Sheffield) from Novartis, 阀psen, HRA Pharma and ONO Pharma. R P has received grants and personal fees from Novartis, Pfizer, HRA Pharma, Viropharma, Shire and 阀psen, personal fees from Ferring and 阀talfarmaco, and grants from Corcept Therapeutics, Cortendo AB and IBSA. A T has received research support and scientific consultancy fees from Novartis and HRA Pharma. M F has received research support (paid to Oregon Health & Science University) from Novartis, Millendo Therapeutics and Strongbridge Biopharma and scientific consultancy fees from Novartis and Strongbridge Biopharma. P W has received travel grants from Novartis and Ipsen Poland and consulting fees from 阀psen, Novartis and Pfizer. P W is the principal investigator in clinical trials sponsored by Novartis, Ipsen, Novo Nordisk and Strongbridge Biopharma. M G has been the principal investigator in clinical trials for Novartis and Ipsen and received consultancy fees from Novartis and speaker fees from Novartis, 阀psen and Pfizer. S P has served as a lecturer for 阀psen, Novartis and Pfizer and as an advisory board member for Ipsen and Novartis. L T, S R and P G are employees of Novartis. A L has received funding as an investigator or consultant from Novartis, Cortendo, Strongbridge Biopharma and GLWL Research, 阀nc. B M K B has been the principal investigator for research grants (paid to Massachusetts General Hospital) from Novartis, Millendo and Strongbridge Biopharma and has received occasional consulting honoraria from Novartis and Strongbridge Biopharma. Andr{\'e} Lacroix is on the editorial board of EJE. Andr{\'e} Lacroix was not involved in the review or editorial process for this paper, on which he/she is listed as an author. Publisher Copyright: {\textcopyright} 2020 The authors Published by Bioscientifica Ltd. Printed in Great Britain.",
year = "2020",
doi = "10.1530/EJE-19-0695",
language = "English (US)",
volume = "182",
pages = "207--217",
journal = "European Journal of Endocrinology",
issn = "0804-4643",
publisher = "BioScientifica Ltd.",
number = "2",
}