Evidence map›Paper›PMID 27209465›Full record

Trial reportEndocrine2016

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

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Endocrine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Approach to the Patient Treated with Steroidogenesis Inhibitors.The Journal of clinical endocrinology and metabolism · 2021
    Article
  11. Review
  12. Cushing's Disease.Journal of clinical medicine · 2019
    Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Pituitary-Directed Therapies for Cushing's Disease.Frontiers in endocrinology · 2018
    Review
  18. Article
  19. Update on medical treatment for Cushing's disease.Clinical diabetes and endocrinology · 2016
    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

8 authors.

James W FindlingDivision of Endocrinology, Metabolism, and Clinical Nutrition, Medical College of Wisconsin, W129 N7055 Northfield Drive Suite A-203, Menomonee Falls, Milwaukee, WI, 53051, USA. jfindling@mcw.edu.
Maria FleseriuDepartments of Medicine and Neurological Surgery, Northwest Pituitary Center, Oregon Health & Science University, Portland, OR, USA.
John Newell-PriceThe Medical School, University of Sheffield, Sheffield, UK.
Stephan PetersennENDOC Center for Endocrine Tumors, Hamburg, Germany.
Rosario PivonelloDipartimento di Medicina Clinica e Chirurgia, Endocrinologia e Metabolismo, Università Federico II di Napoli, Naples, Italy.
Albert KandraNovartis Pharma AG, Basel, Switzerland.
Alberto M PedroncelliNovartis Pharma AG, Basel, Switzerland.
Beverly M K BillerNeuroendocrine Clinical Center, Massachusetts General Hospital, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdultBiomarkersCircadian RhythmDouble-Blind MethodFemaleHumansHydrocortisoneHypothalamo-Hypophyseal SystemMalePituitary ACTH HypersecretionPituitary-Adrenal SystemSalivaSomatostatinTreatment OutcomeBiomarkersHydrocortisonepasireotideSomatostatinCushing’s diseasePasireotideSalivary cortisolUrinary free cortisol

Identifiers

PMID27209465
PMCPMC5083774

What OpenQuestion holds

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Registered trials

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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.