Evidence map›Paper›PMID 24423324›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2014

Pasireotide versus octreotide in acromegaly: a head-to-head superiority study.

A Colao, M D Bronstein, P Freda, F Gu, C-C Shen, M Gadelha, M Fleseriu, A J van der Lely, A J Farrall, K Hermosillo Reséndiz and 4 more

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 186 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
186citing papers in PubMed, 9 pooled it
29.4field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

186 citing papers in PubMed, 9 syntheses or guidelines pooled it, 390 citations in OpenAlex.

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126 more citing papers are in PubMed but not listed here.

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 at 10 institutions in 8 countries.

A ColaoDipartimento di Medicina Clinica e Chirurgia (A.C.), Università Federico II di Napoli, 80131 Naples, Italy; Neuroendocrine Unit (M.D.B.), Division of Endocrinology and Metabolism, University of São Paulo Medical School, 3858-Jardim Paulista, São Paulo, Brazil; Department of Medicine (P.F.), Columbia University College of Physicians and Surgeons, New York, New York 10032; Department of Endocrinology (F.G.), Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China; Department of Neurosurgery (C.-C.S.), Taichung Veterans General Hospital, Taichung 40705, Taiwan; Department of Physical Therapy (C.-C.S.), Hungkuang University, Taichung 43302, Taiwan; Department of Medicine and Tri-Service General Hospital (C.-C.S.), National Defense Medical Center, Taipei 11490, Taiwan; Endocrine Unit (M.G.), Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, 22421020, Brazil; Department of Medicine and Neurological Surgery (M.F.), Northwest Pituitary Center, Oregon Health and Science University, Portland, Oregon 97239; Department of Medicine (A.J.v.d.L.), Erasmus University Medical Center, 3000 CA Rotterdam, The Netherlands; Brain Research Imaging Centre (A.J.F.), University of Edinburgh, Edinburgh EH4 2XU, United Kingdom; Clinical Development (K.H.R., Y.C.), Novartis Pharmaceuticals Corporation, Florham Park, New Jersey 07932; Clinical Development (M.R.), Oncology Business Unit, Novartis Pharma AG, CH-4057 Basel, Switzerland; and Centre for Endocrinology, Diabetes, and Metabolism (M.S.), University of Birmingham, Edgbaston, Birmingham, B152TT.
M D Bronstein
P Freda
F Gu
C-C Shen
M Gadelha
M Fleseriu
A J van der Lely
A J Farrall
K Hermosillo Reséndiz
M Ruffin
Y Chen
M Sheppard
Pasireotide C2305 Study Group
Columbia University · USErasmus MC · NLHungkuang University · TWNovartis (Switzerland) · CHOregon Health & Science University · USPeking Union Medical College Hospital · CNUniversidade de São Paulo · BRUniversidade Federal do Rio de Janeiro · BRUniversity of Edinburgh · GBUniversity of Naples Federico II · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextBiochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control.

objectiveOur objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly. DESIGN AND

settingWe conducted a prospective, randomized, double-blind study at 84 sites in 27 countries. PATIENTS: A total of 358 patients with medically naive acromegaly (GH >5 μg/L or GH nadir ≥1 μg/L after an oral glucose tolerance test (OGTT) and IGF-1 above the upper limit of normal) were enrolled. Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging.

interventionsPatients received pasireotide LAR 40 mg/28 days (n = 176) or octreotide LAR 20 mg/28 days (n = 182) for 12 months. At months 3 and 7, titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, if GH ≥2.5μg/L and/or IGF-1 was above the upper limit of normal.

main outcome measureThe main outcome measure was the proportion of patients in each treatment arm with biochemical control (GH <2.5 μg/L and normal IGF-1) at month 12.

resultsBiochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients (31.3% vs 19.2%; P = .007; 35.8% vs 20.9% when including patients with IGF-1 below the lower normal limit). In pasireotide LAR and octreotide LAR patients, respectively, 38.6% and 23.6% (P = .002) achieved normal IGF-1, and 48.3% and 51.6% achieved GH <2.5 μg/L. 31.0% of pasireotide LAR and 22.2% of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase. Hyperglycemia-related adverse events were more common with pasireotide LAR (57.3% vs 21.7%).

conclusionsPasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly.

Indexed as

AcromegalyAdenomaAdolescentAdultAgedAged, 80 and overAntineoplastic Agents, HormonalFemaleGrowth Hormone-Secreting Pituitary AdenomaHumansMaleMiddle AgedOctreotideSomatostatinTherapeutic EquivalencyYoung AdultAntineoplastic Agents, HormonalOctreotidepasireotideSomatostatin

Identifiers

PMID24423324
PMCPMC3965714
OpenAlexW1996943463

What OpenQuestion holds

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Registered trials

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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.