Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial.

Lucas T, Astorga R

Clinical endocrinology1 Sept 2006Cited by 40 (Europe PMC)

PMID16918950PMCIDPMC1618957DOI10.1111/j.1365-2265.2006.02595.xPepBankPUB-16918950

Summary

Objective and designDepot somatostatin analogues are well accepted as either adjuvant or primary therapy for acromegaly, and their long dosage intervals facilitate adherence to treatment. Our objective was to evaluate whether lanreotide Autogel 120 mg, every 4-8 weeks, was as effective in controlling acromegaly as lanreotide microparticles 30 mg, every 1-2 weeks. PATIENTS DESIGN AND MEASUREMENTS: Patients who had used lanreotide microparticles 30 mg, >or= 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial. Three to five injections of lanreotide Autogel 120 mg were administered. Lanreotide Autogel 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively. GH and insulin-like growth factor (IGF)-1 levels were assessed one dosing interval after the final injections.ResultsNinety-eight patients were enrolled and 93 completed. Steady-state GH concentrations demonstrated similar efficacy between the formulations (upper 95% confidence interval of the quotient, 77.7%). Mean (SE) GH levels were lower with lanreotide Autogel than with lanreotide microparticles (3.8 (0.5) vs 4.3 (0.5) ng/ml; P < 0.001). GH levels < 2.5 ng/ml were observed in 54% and 46% of patients; 40% and 35% having GH < 2.5 ng/ml and normalized IGF-1 with lanreotide Autogel and microparticles, respectively. Symptoms were controlled better with lanreotide Autogel and treatment was well accepted.ConclusionsLanreotide Autogel 120 mg every 4-8 weeks, is at least as effective and as well tolerated in acromegaly as lanreotide microparticles 30 mg injected every 7-14 days.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialEfficacy outcome
In acromegaly patients, lanreotide formulations showed similar steady-state GH efficacy, with an upper 95% confidence interval of the quotient of 77.7%.
In plain wordsIn acromegaly patients, Autogel and microparticle lanreotide showed similar steady-state GH efficacy.
Peptide
Lanreotide
Outcome
Not applicableSteady-state GH efficacy
Study
n = 93
Comparator
lanreotide microparticles 30 mg every 7, 10 or 14 days
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4, 6 or 8 weeksAs given in this study (human).
Measurements
upper 95% confidence interval of the quotient, steady-state GH
77.7%
lanreotide Autogel versus lanreotide microparticles
Source sentences
Summary
Steady-state GH concentrations demonstrated similar efficacy between the formulations (upper 95% confidence interval of the quotient, 77.7%).
2 context sentences(design, population, supporting numbers)
Summary · context
PATIENTS DESIGN AND MEASUREMENTS: Patients who had used lanreotide microparticles 30 mg, >or= 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial.
Summary · context
Lanreotide Autogel 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively.
Show in the study text Report a problemFND-1691895001
02HumanNon-randomized trialEfficacy outcome
In acromegaly patients, mean (SE) GH was lower with lanreotide Autogel than microparticles: 3.8 (0.5) versus 4.3 (0.5) ng/ml (P < 0.001).
In plain wordsIn acromegaly patients, GH was lower with lanreotide Autogel than with lanreotide microparticles.
Peptide
Lanreotide
Outcome
DecreaseMean GH
Study
n = 93
Comparator
lanreotide microparticles 30 mg every 7, 10 or 14 days
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4, 6 or 8 weeksAs given in this study (human).
Measurements
mean GH
3.8 ng/ml
lanreotide Autogel; SE 0.5
mean GH
4.3 ng/ml
lanreotide microparticles; SE 0.5
Source sentences
Summary
Mean (SE) GH levels were lower with lanreotide Autogel than with lanreotide microparticles (3.8 (0.5) vs 4.3 (0.5) ng/ml; P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
PATIENTS DESIGN AND MEASUREMENTS: Patients who had used lanreotide microparticles 30 mg, >or= 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial.
Summary · context
Lanreotide Autogel 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively.
Show in the study text Report a problemFND-1691895002
03HumanNon-randomized trialEfficacy outcome
In acromegaly patients, GH < 2.5 ng/ml occurred in 54% with lanreotide Autogel and 46% with microparticles; the abstract gives no significance test for this.
In plain wordsIn acromegaly patients, GH below 2.5 ng/ml was seen in 54% on lanreotide Autogel and 46% on microparticles. No significance test was reported.
Peptide
Lanreotide
Outcome
IncreaseGH below threshold
Study
n = 93
Comparator
lanreotide microparticles 30 mg every 7, 10 or 14 days
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4, 6 or 8 weeksAs given in this study (human).
Measurements
patients with GH < 2.5 ng/ml
54%
lanreotide Autogel
patients with GH < 2.5 ng/ml
46%
lanreotide microparticles
Source sentences
Summary
GH levels < 2.5 ng/ml were observed in 54% and 46% of patients; 40% and 35% having GH < 2.5 ng/ml and normalized IGF-1 with lanreotide Autogel and microparticles, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
PATIENTS DESIGN AND MEASUREMENTS: Patients who had used lanreotide microparticles 30 mg, >or= 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial.
Summary · context
Lanreotide Autogel 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively.
Show in the study text Report a problemFND-1691895003
04HumanNon-randomized trialEfficacy outcome
In acromegaly patients, GH < 2.5 ng/ml with normalized IGF-1 occurred in 40% with lanreotide Autogel and 35% with microparticles; the abstract gives no significance test for this.
In plain wordsGH below 2.5 ng/ml with normal IGF-1 occurred in 40% on lanreotide Autogel versus 35% on microparticles. No significance test was reported.
Peptide
Lanreotide
Outcome
IncreaseCombined biochemical control
Study
n = 93
Comparator
lanreotide microparticles 30 mg every 7, 10 or 14 days
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
120 mg every 4, 6 or 8 weeksAs given in this study (human).
Measurements
patients with GH < 2.5 ng/ml and normalized IGF-1
40%
lanreotide Autogel
patients with GH < 2.5 ng/ml and normalized IGF-1
35%
lanreotide microparticles
Source sentences
Summary
GH levels < 2.5 ng/ml were observed in 54% and 46% of patients; 40% and 35% having GH < 2.5 ng/ml and normalized IGF-1 with lanreotide Autogel and microparticles, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
PATIENTS DESIGN AND MEASUREMENTS: Patients who had used lanreotide microparticles 30 mg, >or= 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial.
Summary · context
Lanreotide Autogel 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively.
Show in the study text Report a problemFND-1691895004
05HumanNon-randomized trialEfficacy outcome
In acromegaly patients, symptoms were controlled better with lanreotide Autogel than with microparticles.
In plain wordsIn acromegaly patients, lanreotide Autogel controlled symptoms better than lanreotide microparticles.
Peptide
Lanreotide
Outcome
IncreaseSymptom control
Study
n = 93
Comparator
lanreotide microparticles 30 mg every 7, 10 or 14 days
Outcome group
Symptom control · Endocrine and hormones
Studied dose
120 mg every 4, 6 or 8 weeksAs given in this study (human).
Source sentences
Summary
Symptoms were controlled better with lanreotide Autogel and treatment was well accepted.
2 context sentences(design, population, supporting numbers)
Summary · context
PATIENTS DESIGN AND MEASUREMENTS: Patients who had used lanreotide microparticles 30 mg, >or= 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial.
Summary · context
Lanreotide Autogel 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively.
Show in the study text Report a problemFND-1691895005

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT00627796

Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly

Federico II Universityn = 27Jan 2003 to Dec 2007

Acromegaly

Trial page ClinicalTrials.govUpdated 3 Mar 2008

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

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