Evidence map›Paper›PMID 27039081›Full record

Trial reportBMC endocrine disorders2016

Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study.

Marcello D Bronstein, Maria Fleseriu, Sebastian Neggers, Annamaria Colao, Michael Sheppard, Feng Gu, Chiung-Chyi Shen, Mônica Gadelha, Andrew J Farrall, Karina Hermosillo Reséndiz and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC endocrine disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00600886 (A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly), which is not on this map. Cited by 46 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 5 pooled it
–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.

NCT00600886 phase3completednot on this map

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

TypeinterventionalSponsorNovartis PharmaceuticalsRan2008 to 2016Enrolled358ConditionsAcromegalyArmsPasireotide, Octreotide
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Can acromegaly be controlled in all cases?Journal of neuroendocrinology · 2026
    Review
  9. The acromegaly patient experience: burden of treatment and quality of life.The Journal of clinical endocrinology and metabolism · 2026
    Review
  10. Review
  11. Article
  12. Article
  13. Real-life data of Pasireotide LAR in acromegaly: a long-term follow-up.Journal of endocrinological investigation · 2024
    Observational
  14. Article
  15. Review
  16. Article
  17. Review
  18. Pituitary Tumorigenesis-Implications for Management.Medicina (Kaunas, Lithuania) · 2023
    Review
  19. Article
  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

14 authors.

Marcello D BronsteinNeuroendocrine Unit, Division of Endocrinology and Metabolism, University of São Paulo Medical School, São Paulo, Brazil.
Maria FleseriuDepartment of Medicine and Neurological Surgery, Northwest Pituitary Center, Oregon Health & Science University, Portland, OR, USA.
Sebastian NeggersDepartment of Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.
Annamaria ColaoDipartimento di Medicina Clinica e Chirurgia, Università Federico II di Napoli, Naples, Italy.
Michael SheppardCentre for Endocrinology, Diabetes and Metabolism, University of Birmingham, Edgbaston, Birmingham, UK.
Feng GuDepartment of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Beijing, China.
Chiung-Chyi ShenDepartment of Minimally Invasive Skull Neurosurgery, Neurological Institute, Taichung Veterans General Hospital, Taichung, Taiwan.
Mônica GadelhaEndocrine Unit, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Andrew J FarrallBrain Research Imaging Centre, University of Edinburgh, Edinburgh, UK.
Karina Hermosillo ReséndizClinical Development, Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA.
Matthieu RuffinClinical Development, Oncology Business Unit, Novartis Pharma AG, Basel, Switzerland.
YinMiao ChenClinical Development, Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA.
Pamela FredaDepartment of Medicine, Columbia University College of Physicians & Surgeons, William Black Medical Res. Building, Room 9-905, 650 W. 168th Street, New York, NY, 10032, USA. puf1@columbia.edu.
Pasireotide C2305 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues. A large, multicenter, randomized, Phase III core study demonstrated that pasireotide LAR had significantly superior efficacy over octreotide LAR. This analysis explores the efficacy and safety of switching therapeutic arms in inadequately controlled patients during a 12-month crossover extension.

methodsPatients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38). One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.

resultsTwelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure); 27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively; 44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively. Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28); 54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension. The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events.

conclusionsPasireotide LAR is a promising treatment option for patients with acromegaly inadequately controlled with the first-generation somatostatin analogue octreotide LAR.

trial registrationclinicaltrials.gov, NCT00600886 . Registered 14 January 2008.

Indexed as

Drug SubstitutionAcromegalyAdenomaAdultAgedAged, 80 and overBiomarkers, TumorCross-Over StudiesFemaleGrowth Hormone-Secreting Pituitary AdenomaHuman Growth HormoneHumansInsulin-Like Growth Factor IMaleMiddle AgedOctreotideBiomarkers, TumorHuman Growth HormoneInsulin-Like Growth Factor IOctreotidepasireotideSomatostatinAcromegalyCrossoverExtensionOctreotidePasireotide

Identifiers

PMID27039081
PMCPMC4818908

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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.