Evidence map›Paper›PMID 19639415›Full record

Trial reportPituitary2010

Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension.

Shlomo Melmed, David Cook, Jochen Schopohl, Miklos I Goth, Karen S L Lam, Josef Marek

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pituitary, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00234572 (Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel), which is not on this map. Cited by 51 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 3 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.

NCT00234572 phase2 / phase3completednot on this map

Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

TypeinterventionalSponsorIpsenRan2000 to 2003Enrolled108ConditionsAcromegalyArmsLanreotide (Autogel formulation)
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  13. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study.The Journal of clinical endocrinology and metabolism · 2014
    Trial
  14. Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026
    Review
  15. Article
  16. Article
  17. The p300 Inhibitor A-485 Exerts Antitumor Activity in Growth Hormone Pituitary Adenoma.The Journal of clinical endocrinology and metabolism · 2022
    Article
  18. Article
  19. Article
  20. 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

6 authors.

Shlomo MelmedDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Shlomo.melmed@cshs.org
David Cook
Jochen Schopohl
Miklos I Goth
Karen S L Lam
Josef Marek

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly. The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored according to biochemical response. Serum samples were assessed for growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, at weeks 4, 13, 14, 15, 16, 32 and 52. 108 patients were enrolled and 99 completed 52 weeks' treatment. Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001). After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1. The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively. In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control (combined criterion). Treatment was well tolerated by all patients. In conclusion, Lan-Autogel was effective in controlling GH and IGF-1 hypersecretion in patients with acromegaly and showed a rapid onset of action.

Indexed as

AcromegalyAdultAgedAge FactorsAntineoplastic AgentsDrug-Related Side Effects and Adverse ReactionsFemaleHuman Growth HormoneHumansInsulin-Like Growth Factor IMaleMiddle AgedPeptides, CyclicSex FactorsSomatostatinAntineoplastic AgentsHuman Growth HormoneInsulin-Like Growth Factor IlanreotidePeptides, CyclicSomatostatin

Identifiers

PMID19639415
PMCPMC2807598

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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.