Evidence map›Paper›PMID 39610378›Full record

ArticleJournal of the Endocrine Society2024

Improved Clinical Outcomes During Long-term Osilodrostat Treatment of Cushing Disease With Normalization of Late-night Salivary Cortisol and Urinary Free Cortisol.

John Newell-Price, Maria Fleseriu, Rosario Pivonello, Richard A Feelders, Mônica R Gadelha, André Lacroix, Przemysław Witek, Anthony P Heaney, Andrea Piacentini, Alberto M Pedroncelli and 1 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Journal of the Endocrine Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT02180217 phase3completednot on this map

Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2019Enrolled137ConditionsCushings DiseaseArmsosilodrostat, LCI699 matching placebo
NCT02697734 phase3completednot on this map

A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2020Enrolled73ConditionsCushing's DiseaseArmsosilodrostat, osilodrostat Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Observational
  6. Real-World Osilodrostat Effectiveness and Safety in Nonpituitary Cushing Syndrome.The Journal of clinical endocrinology and metabolism · 2026
    Observational
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
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

11 authors.

John Newell-PriceThe School of Medicine and Population Health, University of Sheffield, Sheffield S10 2RX, UK.ORCID https://orcid.org/0000-0002-0835-5493
Maria FleseriuPituitary Center, Departments of Medicine and Neurological Surgery, Oregon Health & Science University, Portland, OR 97239, USA.ORCID https://orcid.org/0000-0001-9284-6289
Rosario PivonelloDipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università Federico II di Napoli, 80138 Naples, Italy.ORCID https://orcid.org/0000-0002-9632-1348
Richard A FeeldersDepartment of Internal Medicine, Endocrine Section, Erasmus Medical Center, 3015 GD Rotterdam, Netherlands.ORCID https://orcid.org/0000-0003-2319-391X
Mônica R GadelhaNeuroendocrinology Research Center, Endocrinology Section, Medical School and Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro 21941-617, Brazil.
André LacroixDepartment of Medicine, Centre hospitalier de l'Université de Montréal, Montreal, QC H2X 0A9, Canada.ORCID https://orcid.org/0000-0003-4137-3025
Przemysław WitekDepartment of Internal Medicine, Endocrinology and Diabetes, Medical University of Warsaw, 02-091 Warsaw, Poland.
Anthony P HeaneyDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA.
Andrea PiacentiniRecordati SpA, 20148 Milan, Italy.
Alberto M PedroncelliRecordati AG, 4057 Basel, Switzerland.
Beverly M K BillerNeuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital, Boston, MA 02114, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To assess whether simultaneous normalization of late-night salivary cortisol (LNSC) and mean urinary free cortisol (mUFC) in patients with Cushing disease treated with osilodrostat is associated with better clinical outcomes than control of mUFC or LNSC alone. Methods: Pooled data from two phase III osilodrostat studies (LINC 3 and LINC 4) were analyzed. Both comprised a 48-week core phase and an optional open-label extension. Changes in cardiovascular/metabolic-related parameters, physical manifestations of hypercortisolism, and quality of life (QoL) were evaluated across the following patient subgroups: both LNSC and mUFC controlled, only mUFC controlled, only LNSC controlled, and neither controlled. Results: Of 160 patients included in the analysis, 85.0% had both LNSC and mUFC uncontrolled at baseline. At week 72, 48.6% of patients had both LNSC and mUFC controlled; these patients generally exhibited greater improvements in cardiovascular/metabolic-related parameters than those with only mUFC controlled or both LNSC and mUFC uncontrolled: systolic/diastolic blood pressure, -7.4%/-4.9%, -6.0%/-5.5%, and 2.3%/0.8%, respectively; fasting plasma glucose, -5.0%, -4.8%, and 1.9%; glycated hemoglobin, -5.1%, -4.8%, and -1.3%. Weight, waist circumference, and body mass index improved with control of LNSC and/or mUFC; physical manifestations of hypercortisolism generally improved regardless of LNSC/mUFC control. Patients with both LNSC and mUFC controlled or only mUFC controlled had the greatest improvement from baseline to week 72 in QoL. Conclusion: In osilodrostat-treated patients with Cushing disease, normalization of LNSC and mUFC led to improvements in long-term outcomes, indicating that treatment should aim for normalization of both parameters for optimal patient outcomes. Clinical trial identifiers: NCT02180217 (LINC 3); NCT02697734 (LINC 4).

Indexed as

cortisol normalizationCushing diseasehypercortisolismlong-term treatmentosilodrostat

Identifiers

PMID39610378
PMCPMC11604051

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.