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Study · Non-randomized trial · n = 67 · 2016

8 results

Late-night salivary cortisol may be valuable for assessing treatment response in patients with Cushing's disease: 12-month, Phase III pasireotide study.

Findling JW, Fleseriu M, Newell-Price J, Petersenn S, Pivonello R, Kandra A, Pedroncelli AM, Biller BM

Endocrine21 May 2016Cited by 24 (Europe PMC)

PMID27209465 (opens in a new tab)PMCIDPMC5083774 (opens in a new tab)DOI10.1007/s12020-016-0978-6 (opens in a new tab)PepBankPUB-27209465
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Summary

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.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In Cushing's disease patients with elevated baseline LNSC receiving pasireotide, LNSC normalized in 25/67 (37.3%) at month 6.

    In plain wordsIn Cushing's disease patients with elevated baseline saliva cortisol receiving pasireotide, 37.3% had normal saliva cortisol at month 6.

    Peptide
    Pasireotide
    Outcome
    Not applicableLNSC normalization at month 6
    Study

    n = 67

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    600 or 900 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Patients with normalized LNSC
    37.3%
    month 6, 25 of 67 patients with baseline LNSC > ULN
    Patients with normalized LNSC
    25 patients
    month 6, of 67

    Source sentences

    Summary
    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).
    3 context sentences
    Summary · context
    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.
    Summary · context
    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.
    Summary · context
    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.
  2. 02HumanNon-randomized trialEfficacy outcome

    In Cushing's disease patients with elevated baseline LNSC receiving pasireotide, LNSC normalized in 13/67 (19.4%) at month 12.

    In plain wordsIn Cushing's disease patients with elevated baseline saliva cortisol receiving pasireotide, 19.4% had normal saliva cortisol at month 12.

    Peptide
    Pasireotide
    Outcome
    Not applicableLNSC normalization at month 12
    Study

    n = 67

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    600 or 900 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Patients with normalized LNSC
    19.4%
    month 12, 13 of 67 patients with baseline LNSC > ULN
    Patients with normalized LNSC
    13 patients
    month 12, of 67

    Source sentences

    Summary
    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).
    3 context sentences
    Summary · context
    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.
    Summary · context
    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.
    Summary · context
    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.
  3. 03HumanNon-randomized trialEfficacy outcome

    In pasireotide-treated Cushing's disease patients with normalized LNSC at month 6, 10/25 also had normalized UFC.

    In plain wordsIn pasireotide-treated Cushing's disease patients with normal saliva cortisol at month 6, 10/25 also had normal urinary cortisol.

    Peptide
    Pasireotide
    Outcome
    Not applicableUFC normalization among LNSC responders at month 6
    Study

    n = 25

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    600 or 900 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Patients with normalized UFC among those with normalized LNSC
    10 patients
    month 6; of 25 with normalized LNSC

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    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.
  4. 04HumanNon-randomized trialEfficacy outcome

    In pasireotide-treated Cushing's disease patients with normalized LNSC at month 6, 7/25 had UFC above normal but at least 50% below baseline.

    In plain wordsIn pasireotide-treated patients with normal saliva cortisol at month 6, 7/25 had urinary cortisol above normal but at least 50% below baseline.

    Peptide
    Pasireotide
    Outcome
    Not applicablePartial UFC control among LNSC responders at month 6
    Study

    n = 25

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    600 or 900 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Patients with partial UFC control among those with normalized LNSC
    7 patients
    month 6; of 25 with normalized LNSC; UFC > ULN and >=50% decrease from baseline

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    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.
  5. 05HumanNon-randomized trialEfficacy outcome

    In Cushing's disease patients with elevated baseline LNSC, pasireotide 600 μg reduced median LNSC by 13.4 nmol/L (52.6%) at month 12.

    In plain wordsIn Cushing's disease patients with elevated baseline saliva cortisol, pasireotide 600 μg reduced median saliva cortisol by 52.6% at month 12.

    Peptide
    Pasireotide
    Outcome
    DecreaseLNSC change with 600 μg
    Study

    n = 19

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    600 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Median change in late-night salivary cortisol
    −13.4 nmol/L
    600 μg group, baseline LNSC > ULN, month 12
    Median percent change in late-night salivary cortisol
    −52.6%
    600 μg group, baseline LNSC > ULN, month 12

    Source sentences

    Summary
    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.
    3 context sentences
    Summary · context
    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.
    Summary · context
    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.
    Summary · context
    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.
  6. 06HumanNon-randomized trialEfficacy outcome

    In Cushing's disease patients with elevated baseline LNSC, pasireotide 900 μg reduced median LNSC by 11.8 nmol/L (56.1%) at month 12.

    In plain wordsIn Cushing's disease patients with elevated baseline saliva cortisol, pasireotide 900 μg reduced median saliva cortisol by 56.1% at month 12.

    Peptide
    Pasireotide
    Outcome
    DecreaseLNSC change with 900 μg
    Study

    n = 14

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    900 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Median change in late-night salivary cortisol
    −11.8 nmol/L
    900 μg group, baseline LNSC > ULN, month 12
    Median percent change in late-night salivary cortisol
    −56.1%
    900 μg group, baseline LNSC > ULN, month 12

    Source sentences

    Summary
    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.
    3 context sentences
    Summary · context
    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.
    Summary · context
    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.
    Summary · context
    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.
  7. 07HumanNon-randomized trialEfficacy outcome

    In pasireotide-treated Cushing's disease patients with normalized LNSC at month 12, 8/13 also had normalized UFC.

    In plain wordsIn pasireotide-treated Cushing's disease patients with normal saliva cortisol at month 12, 8/13 also had normal urinary cortisol.

    Peptide
    Pasireotide
    Outcome
    Not applicableUFC normalization among LNSC responders at month 12
    Study

    n = 13

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    600 or 900 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Patients with normalized UFC among those with normalized LNSC
    8 patients
    month 12; of 13 with normalized LNSC

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    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.
  8. 08HumanNon-randomized trialEfficacy outcome

    In pasireotide-treated Cushing's disease patients with normalized LNSC at month 12, 4/13 had UFC above normal but at least 50% below baseline.

    In plain wordsIn pasireotide-treated patients with normal saliva cortisol at month 12, 4/13 had urinary cortisol above normal but at least 50% below baseline.

    Peptide
    Pasireotide
    Outcome
    Not applicablePartial UFC control among LNSC responders at month 12
    Study

    n = 13

    Analysis
    Exploratory
    Outcome group
    Cortisol Control · Endocrine and hormones
    Studied dose
    600 or 900 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Patients with partial UFC control among those with normalized LNSC
    4 patients
    month 12; of 13 with normalized LNSC; UFC > ULN and >=50% decrease from baseline

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

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