Evidence map›Paper›PMID 32385851›Full record

Trial reportJournal of endocrinological investigation2020

Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study.

A Lacroix, M D Bronstein, J Schopohl, T Delibasi, R Salvatori, Y Li, A Barkan, N Suzaki, L Tauchmanova, C-E Ortmann and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of endocrinological investigation, 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 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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

13 authors at 11 institutions in 9 countries.

A LacroixCentre hospitalier de l'Université de Montréal, 3840 Saint-Urbain, Montreal, H2W1T8, Canada. andre.lacroix@umontreal.ca.ORCID http://orcid.org/0000-0003-4137-3025
M D BronsteinUniversity of São Paulo Medical School, São Paulo, Brazil.
J SchopohlMedizinische Klinik und Poliklinik IV, Ludwig-Maximilians-Universität München, Munich, Germany.
T DelibasiHacettepe University, Ankara, Turkey.
R SalvatoriDivision of Endocrinology, Diabetes and Metabolism, and Pituitary Center, Johns Hopkins University, Baltimore, MD, USA.
Y LiDepartment of Endocrinology and Metabolism, Huashan Hospital, Fudan University, Shanghai, China.
A BarkanUniversity of Michigan, Ann Arbor, MI, USA.
N SuzakiNagoya Medical Center, National Hospital Organization, Nagoya, Japan.
L TauchmanovaNovartis Pharma AG, Basel, Switzerland.
C-E OrtmannNovartis Pharma AG, Basel, Switzerland.
S RavichandranNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
S PetersennENDOC Center for Endocrine Tumors, Hamburg, Germany.
R PivonelloUniversità Federico II di Napoli, Naples, Italy.
Novartis (Switzerland) · CHCentre Hospitalier de l’Université de Montréal · CAFudan University · CNHacettepe University · TRJohns Hopkins University · USLudwig-Maximilians-Universität München · DENational Hospital Organization · JPNovartis (United States) · USUniversidade de São Paulo · BRUniversity of Michigan · USUniversity of Naples Federico II · IT

Funding

Novartis Pharma AG -
6 · The paper itself

Abstract

purposeCushing's disease (CD) is associated with significant clinical burden, increased mortality risk, and impaired health-related quality of life (HRQoL). This analysis explored the effect of long-acting pasireotide on clinical signs of hypercortisolism and HRQoL in a large subset of patients with CD.

methodsIn this phase III study (clinicaltrials.gov: NCT01374906), 150 adults with CD and a mean urinary free cortisol (mUFC) level between 1.5 and 5.0 times the upper limit of normal (ULN) started long-acting pasireotide 10 or 30 mg every 28 days with dose increases/decreases permitted based on mUFC levels/tolerability (minimum/maximum dose: 5/40 mg). Changes in clinical signs of hypercortisolism and HRQoL were assessed over 12 months of treatment and were stratified by degree of mUFC control for each patient.

resultsPatients with controlled mUFC at month 12 (n = 45) had the greatest improvements from baseline in mean systolic (- 8.4 mmHg [95% CI - 13.9, - 2.9]) and diastolic blood pressure (- 6.0 mmHg [- 10.0, - 2.0]). Mean BMI, weight, and waist circumference improved irrespective of mUFC control. Significant improvements in CushingQoL total score of 5.9-8.3 points were found at month 12 compared with baseline, irrespective of mUFC control; changes were driven by improvements in physical problem score, with smaller improvements in psychosocial score.

conclusionsLong-acting pasireotide provided significant improvements in clinical signs and HRQoL over 12 months of treatment, which, in some cases, occurred regardless of mUFC control. Long-acting pasireotide represents an effective treatment option and provides clinical benefit in patients with CD. CLINICAL TRIAL REGISTRATION NUMBER: NCT01374906.

Indexed as

Quality of LifeAdultAgedBlood PressureCushing SyndromeDelayed-Action PreparationsFemaleHumansHydrocortisoneMaleMiddle AgedPituitary ACTH HypersecretionSomatostatinTreatment OutcomeDelayed-Action PreparationsHydrocortisonepasireotideSomatostatinCushing’s diseaseHealth-related quality of lifeHypercortisolismPasireotide

Identifiers

PMID32385851
OpenAlexW3022616057

What OpenQuestion holds

Textmetadata
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.