Late-night salivary cortisol may be valuable for assessing treatment response in patients with Cushing’s disease

12-month, Phase III pasireotide study

James W. Findling, Maria Fleseriu, John Newell-Price, Stephan Petersenn, Rosario Pivonello, Albert Kandra, Alberto M. Pedroncelli, Beverly M K Biller

Research output: Contribution to journalArticle

8 Citations (Scopus)

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 μg 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 μg (n = 40) and 900 μg (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 μg 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 ≥50 % 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.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalEndocrine
DOIs
StateAccepted/In press - May 21 2016

Fingerprint

Pituitary ACTH Hypersecretion
Hydrocortisone
Therapeutics
pasireotide
Cushing Syndrome
Physiologic Monitoring

Keywords

  • Cushing’s disease
  • Pasireotide
  • Salivary cortisol
  • Urinary free cortisol

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Late-night salivary cortisol may be valuable for assessing treatment response in patients with Cushing’s disease : 12-month, Phase III pasireotide study. / Findling, James W.; Fleseriu, Maria; Newell-Price, John; Petersenn, Stephan; Pivonello, Rosario; Kandra, Albert; Pedroncelli, Alberto M.; Biller, Beverly M K.

In: Endocrine, 21.05.2016, p. 1-8.

Research output: Contribution to journalArticle

Findling, James W. ; Fleseriu, Maria ; Newell-Price, John ; Petersenn, Stephan ; Pivonello, Rosario ; Kandra, Albert ; Pedroncelli, Alberto M. ; Biller, Beverly M K. / Late-night salivary cortisol may be valuable for assessing treatment response in patients with Cushing’s disease : 12-month, Phase III pasireotide study. In: Endocrine. 2016 ; pp. 1-8.
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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 μg 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 μg (n = 40) and 900 μg (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 μg 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 ≥50 {\%} 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.",
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