Evidence map›Paper›PMID 31804965›Full record

Trial reportEuropean journal of endocrinology2020

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

John Newell-Price, Rosario Pivonello, Antoine Tabarin, Maria Fleseriu, Przemysław Witek, Mônica R Gadelha, Stephan Petersenn, Libuse Tauchmanova, Shoba Ravichandran, Pritam Gupta and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in European journal of endocrinology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01374906 (A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease), which is not on this map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
4.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01374906 phase3completednot on this map

A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2016Enrolled150ConditionsCushing's DiseaseArmspasireotide LAR, SOM230 LAR 30 mg, SOM230 LAR 10 mg
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 60 citations in OpenAlex.

  1. Trial
  2. Randomized Trial of Osilodrostat for the Treatment of Cushing Disease.The Journal of clinical endocrinology and metabolism · 2022
    Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Cardiometabolic complications after Cushing's disease remission.Journal of endocrinological investigation · 2025
    Observational
  10. Review
  11. Article
  12. Medical Treatment of Cushing's Syndrome.Endocrinology and metabolism (Seoul, Korea) · 2025
    Review
  13. Cushing syndrome.Nature reviews. Disease primers · 2025
    Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 11 institutions in 9 countries.

John Newell-PriceThe Medical School, University of Sheffield, Sheffield, UK.
Rosario PivonelloUniversità Federico II di Napoli, Naples, Italy.
Antoine TabarinDepartment of Endocrinology, CHU of Bordeaux, Bordeaux, France.
Maria FleseriuNorthwest Pituitary Center, Oregon Health & Science University, Portland, Oregon, USA.
Przemysław WitekDepartment of Endocrinology, Military Institute of Medicine and Department of Internal Medicine, Endocrinology and Diabetes, Medical University of Warsaw, Warsaw, Poland.
Mônica R GadelhaHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Stephan PetersennENDOC Center for Endocrine Tumors, Hamburg, Germany.
Libuse TauchmanovaNovartis Pharma AG, Basel, Switzerland.
Shoba RavichandranNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Pritam GuptaNovartis Healthcare Private Limited, Hyderabad, India.
André LacroixCentre Hospitalier de l'Université de Montréal, Montreal, Canada.
Beverly M K BillerNeuroendocrine Clinical Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
Centre Hospitalier de l’Université de Montréal · CACentre Hospitalier Universitaire de Bordeaux · FRMassachusetts General Hospital · USMedical University of Warsaw · PLNovartis (India) · INNovartis (Switzerland) · CHNovartis (United States) · USOregon Health & Science University · USUniversidade Federal do Rio de Janeiro · BRUniversity of Naples Federico II · ITUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Circadian RhythmACTH-Secreting Pituitary AdenomaAdultFemaleHormonesHumansHydrocortisoneMaleMiddle AgedPituitary ACTH HypersecretionPituitary NeoplasmsSalivaSomatostatinTreatment OutcomeHormonesHydrocortisonepasireotideSomatostatin

Identifiers

PMID31804965
PMCPMC7003692
OpenAlexW2992631679

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.