Evidence map›Paper›PMID 23529827›Full record

Trial reportPituitary2014

Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-ended, multicenter, Phase II extension study.

Stephan Petersenn, Andrew J Farrall, Christophe De Block, Christophe Block, Shlomo Melmed, Jochen Schopohl, Philippe Caron, Ross Cuneo, David Kleinberg, Annamaria Colao and 5 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Pituitary, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00171730 (Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT00171730 phase2completednot on this map

Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients

TypeinterventionalSponsorNovartis PharmaceuticalsRan2004 to 2013Enrolled30ConditionsAcromegalyArmsPasireotide
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Pituitary adenoma imaging as a determinant of acromegaly diagnosis and outcomes.The Journal of clinical endocrinology and metabolism · 2026
    Review
  6. Article
  7. Article
  8. Review
  9. Pasireotide-a novel somatostatin receptor ligand after 20 years of use.Reviews in endocrine & metabolic disorders · 2022
    Review
  10. Article
  11. Review
  12. Review
  13. Radiotherapy and pasireotide treatment of a growth hormone producing pituitary tumor in a diabetic dog.The Canadian veterinary journal = La revue veterinaire canadienne · 2018
    Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

  • Erratum issued
    Block, Christophe [corrected to De Block, Christophe]
5 · Who and what money

Authors and funding

15 authors at 11 institutions in 8 countries.

Stephan PetersennENDOC Center for Endocrine Tumors, Altonaer Str. 59, 20357, Hamburg, Germany, stephan.petersenn@endoc-med.de.
Andrew J Farrall
Christophe De Block
Christophe Block
Shlomo Melmed
Jochen Schopohl
Philippe Caron
Ross Cuneo
David Kleinberg
Annamaria Colao
Matthieu Ruffin
Karina Hermosillo Reséndiz
Gareth Hughes
Ke Hu
Ariel Barkan
Novartis (France) · FRNovartis (Switzerland) · CHAntwerp University Hospital · BECedars-Sinai Medical Center · USHôpital Larrey · FRLMU Klinikum · DENew York University · USPrincess Alexandra Hospital · AUUniversity of Michigan · USUniversity of Naples Federico II · ITWestern General Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pasireotide has a broader somatostatin receptor binding profile than other somatostatin analogues. A 16-week, Phase II trial showed that pasireotide may be an effective treatment for acromegaly. An extension to this trial assessed the long-term efficacy and safety of pasireotide. This study was an open-label, single-arm, open-ended extension study (primary efficacy and safety evaluated at month 6). Patients could enter the extension if they achieved biochemical control (GH ≤ 2.5 μg/L and normal IGF-1) or showed clinically relevant improvements during the core study. Thirty of the 60 patients who received pasireotide (200-900 μg bid) in the core study entered the extension. At extension month 6, of the 26 evaluable patients, six were biochemically controlled, of whom five had achieved control during the core study. Normal IGF-1 was achieved by 13/26 patients and GH ≤ 2.5 μg/L by 12/26 at month 6. Nine patients received pasireotide for ≥24 months in the extension; three who were biochemically controlled at month 24 had achieved control during the core study. Of 29 patients with MRI data, nine had significant (≥20%) tumor volume reduction during the core study; an additional eight had significant reduction during the extension. The most common adverse events were transient gastrointestinal disturbances; hyperglycemia-related events occurred in 14 patients. Twenty patients had fasting plasma glucose shifted to a higher category during the extension. However, last available glucose measurements were normal for 17 patients. Pasireotide has the potential to be an effective, long-term medical treatment for acromegaly, providing sustained biochemical control and significant reductions in tumor volume.

Indexed as

AcromegalyAdenomaAdolescentAdultAgedAged, 80 and overFemaleGrowth HormoneGrowth Hormone-Secreting Pituitary AdenomaHumansInjections, SubcutaneousInsulin-Like Growth Factor IMagnetic Resonance ImagingMaleMiddle AgedPituitary NeoplasmsGrowth HormoneInsulin-Like Growth Factor IpasireotideSomatostatin

Identifiers

PMID23529827
PMCPMC3942632
OpenAlexW2120889045

What OpenQuestion holds

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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 OpenQuestion graph.