Use of late-night salivary cortisol to monitor response to medical treatment in Cushing's disease.

Newell-Price J, Pivonello R, Tabarin A, Fleseriu M, Witek P, Gadelha MR, Petersenn S, Tauchmanova L, Ravichandran S, Gupta P, Lacroix A, Biller BMK

European journal of endocrinology1 Feb 2020Cited by 54 (Europe PMC)

PMID31804965PMCIDPMC7003692DOI10.1530/eje-19-0695PepBankPUB-31804965

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Summary

ObjectiveMonitoring of patients with Cushing'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's disease.DesignExploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing's disease (clinicaltrials.gov: NCT01374906).MethodsMean 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.ResultsAt 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'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.ConclusionmUFC and mLNSC are complementary measurements for monitoring treatment response in Cushing's disease, with better clinical outcomes seen for patients in whom both mUFC and mLNSC are controlled.

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

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialEfficacy outcome
Among evaluable pasireotide-treated Cushing's disease patients at month 12, 17.4% had both mean late-night salivary and urinary free cortisol ≤ULN.
In plain wordsAt month 12, 17.4% of evaluable pasireotide-treated Cushing's disease patients had both salivary and urinary cortisol within normal limits.
Peptide
Pasireotide
Outcome
Not applicableJoint salivary and urinary cortisol control at month 12
Study
n = 92
Analysis
Exploratory
Outcome group
Disease control · Endocrine and hormones
Studied dose
Dose not stated
Measurements
Both mLNSC and mUFC ≤ULN
17.4%
month 12, evaluable patients (n = 92)
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing's disease (clinicaltrials.gov: NCT01374906).
Summary · context
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]).
Show in the study text Report a problemFND-3180496501
02HumanNon-randomized trialEfficacy outcome
Among evaluable pasireotide-treated Cushing's disease patients at month 12, 22.8% had mean late-night salivary cortisol ≤ULN.
In plain wordsAt month 12, 22.8% of evaluable pasireotide-treated Cushing's disease patients had late-night salivary cortisol within normal limits.
Peptide
Pasireotide
Outcome
Not applicableSalivary cortisol control at month 12
Study
n = 92
Analysis
Exploratory
Outcome group
Disease control · Endocrine and hormones
Studied dose
Dose not stated
Measurements
mLNSC ≤ULN
22.8%
month 12, evaluable patients (n = 92)
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing's disease (clinicaltrials.gov: NCT01374906).
Summary · context
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]).
Show in the study text Report a problemFND-3180496502
03HumanNon-randomized trialEfficacy outcome
Among evaluable pasireotide-treated Cushing's disease patients at month 12, 45.7% had mean urinary free cortisol ≤ULN.
In plain wordsAt month 12, 45.7% of evaluable pasireotide-treated Cushing's disease patients had urinary cortisol within normal limits.
Peptide
Pasireotide
Outcome
Not applicableUrinary cortisol control at month 12
Study
n = 92
Analysis
Exploratory
Outcome group
Disease control · Endocrine and hormones
Studied dose
Dose not stated
Measurements
mUFC ≤ULN
45.7%
month 12, evaluable patients (n = 92)
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing's disease (clinicaltrials.gov: NCT01374906).
Summary · context
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]).
Show in the study text Report a problemFND-3180496503
04HumanNon-randomized trialEfficacy outcome
In Cushing's disease, mean late-night salivary cortisol decreased over 12 months of pasireotide treatment, paralleling urinary free cortisol changes.
In plain wordsIn Cushing's disease, late-night salivary cortisol decreased over 12 months of pasireotide treatment.
Peptide
Pasireotide
Outcome
DecreaseSalivary cortisol change
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Disease control · Endocrine and hormones
Studied dose
Dose not stated · 12 monthsAs given in this study (human).
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing's disease (clinicaltrials.gov: NCT01374906).
Summary · context
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]).
Show in the study text Report a problemFND-3180496504
05HumanObservational studyEfficacy outcome
In pasireotide-treated Cushing's disease patients, joint salivary and urinary cortisol control was linked to greater systolic/diastolic blood pressure and weight improvements.
In plain wordsIn pasireotide-treated Cushing's disease patients, joint cortisol control was linked to greater blood pressure and weight improvements than without joint control.
Peptide
Pasireotide
Outcome
Direction not reportedBlood pressure and weight improvements by cortisol control
Study
n: not reported in source
Comparator
Patients without joint mLNSC and mUFC control
Analysis
Exploratory
Outcome group
Disease control · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Greater improvements in systolic/diastolic blood pressure and weight were seen in patients with both mLNSC ≤ULN and mUFC ≤ULN.
2 context sentences(design, population, supporting numbers)
Summary · context
Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing's disease (clinicaltrials.gov: NCT01374906).
Summary · context
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]).
Show in the study text Report a problemFND-3180496508

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Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01374906

Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

Novartis Pharmaceuticalsn = 1504 Nov 2011 to 21 Dec 2016

Cushing's Disease

Trial page ClinicalTrials.govUpdated 22 May 2018

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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