Evidence map›Paper›PMID 31465533›Full record

Trial reportClinical endocrinology2019

Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study.

Maria Fleseriu, Stephan Petersenn, Beverly M K Biller, Pinar Kadioglu, Christophe De Block, Guy T'Sjoen, Marie-Christine Vantyghem, Libuse Tauchmanova, Judi Wojna, Michael Roughton and 2 more

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

Trial report in Clinical endocrinology, 2019. 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 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Cardiometabolic complications after Cushing's disease remission.Journal of endocrinological investigation · 2025
    Observational
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Advances in pharmacological treatment of CushingZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. 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

12 authors at 10 institutions in 7 countries.

Maria FleseriuNorthwest Pituitary Center, Oregon Health & Science University, Portland, OR, USA.ORCID 0000-0001-9284-6289
Stephan PetersennENDOC Center for Endocrine Tumors, Hamburg, Germany.
Beverly M K BillerMassachussetts General Hospital, Boston, MA, USA.
Pinar KadiogluPituitary Center, Istanbul University, Istanbul, Turkey.ORCID 0000-0002-8329-140X
Christophe De BlockDepartment of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, Antwerp, Belgium.
Guy T'SjoenDepartment of Endocrinology and Center for Sexology and Gender, Ghent University Hospital, Ghent, Belgium.
Marie-Christine VantyghemEndocrinology, Diabetology and Metabolism, CHU Lille, Lille, France.
Libuse TauchmanovaNovartis Pharma AG, Basel, Switzerland.
Judi WojnaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Michael RoughtonNovartis Pharma AG, Basel, Switzerland.
André LacroixCentre hospitalier de l'Université de Montréal, Montreal, QC, Canada.
John Newell-PriceUniversity of Sheffield, Sheffield, UK.
Novartis (Switzerland) · CHAntwerp University Hospital · BECentre Hospitalier de l’Université de Montréal · CACentre Hospitalier Universitaire de Lille · FRGhent University Hospital · BEIstanbul University · TRMassachusetts General Hospital · USNovartis (United States) · USOregon Health & Science University · USUniversity of Sheffield · GB

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
NCATS NIH HHS UL1 TR002369
6 · The paper itself

Abstract

objectivesMany patients with Cushing's disease (CD) require chronic pharmacotherapy to control their hypercortisolism. We evaluated the efficacy and safety of long-acting pasireotide during a long-term extension study in patients with CD.

designOpen-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906). PATIENTS: Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.

resultsEighty-one of 150 (54.0%) enrolled patients entered the extension. Median overall exposure to pasireotide at study end was 23.9 months; 39/81 (48.1%) patients completed the extension (received ≥ 12 months' treatment during the extension and could transit to a separate pasireotide safety study). mUFC was ≤ULN in 42/81 (51.9%), 13/81 (16.0%) and 43/81 (53.1%) patients at extension baseline, month (M) 36 and last assessment. Median mUFC remained within normal limits. Median late-night salivary cortisol was 2.6 × ULN at core baseline and 1.3 × ULN at M36. Clinical improvements were sustained over time. Forty-two (51.9%) patients discontinued during the extension: 25 (30.9%) before M24 and 17 (21.0%) after M24. Hyperglycaemia-related AEs occurred in 39.5% of patients. Mean fasting glucose (FPG) and glycated haemoglobin (HbA

conclusionsLong-acting pasireotide provided sustained biochemical and clinical improvements, with no new safety signals emerging, supporting its use as an effective long-term therapy for CD.

Indexed as

Adrenocorticotropic HormoneCushing SyndromeDouble-Blind MethodFastingFemaleHumansHydrocortisoneMalePituitary ACTH HypersecretionSomatostatinTimeTreatment OutcomeAdrenocorticotropic HormoneHydrocortisonepasireotideSomatostatinCushing's diseaseCushing syndromeextensionhypercortisolismpasireotidePhase IIIpituitary

Identifiers

PMID31465533
PMCPMC6899900
OpenAlexW2970084329

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.