Efficacy, safety, and pharmacokinetics of sustained-release lanreotide (lanreotide Autogel) in Japanese patients with acromegaly or pituitary gigantism.

Shimatsu A, Teramoto A, Hizuka N, Kitai K, Ramis J, Chihara K

Endocrine journal19 Jan 2013Cited by 18 (Europe PMC)

PMID23337477DOI10.1507/endocrj.ej12-0417PepBankPUB-23337477

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

01HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients, 41% achieved GH below 2.5 ng/mL four weeks after the first lanreotide injection.
In plain wordsIn Japanese acromegaly or gigantism patients, 41% reached the growth hormone target four weeks after the first lanreotide injection.
Peptide
Lanreotide
Outcome
Not applicableGH target at four weeks
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90, or 120 mg · 4 weeksAs given in this study (human).
Measurements
Patients with serum GH below 2.5 ng/mL at 4 weeks
41%
after first lanreotide Autogel injection
Source sentences
Summary
Four weeks after the first injection, 41% of patients achieved serum GH level of <2.5 ng/mL and insulin-like growth factor-I (IGF-I) level was normalized in 31%.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747701
02HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients, 31% normalized IGF-I four weeks after the first lanreotide injection.
In plain wordsIn Japanese acromegaly or gigantism patients, 31% reached normal IGF-I four weeks after the first lanreotide injection.
Peptide
Lanreotide
Outcome
Not applicableIGF-I normalization at four weeks
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90, or 120 mg · 4 weeksAs given in this study (human).
Measurements
Patients with normalized IGF-I at 4 weeks
31%
after first lanreotide Autogel injection
Source sentences
Summary
Four weeks after the first injection, 41% of patients achieved serum GH level of <2.5 ng/mL and insulin-like growth factor-I (IGF-I) level was normalized in 31%.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747702
03HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients, 53% reached the GH target at Week 24 with lanreotide.
In plain wordsIn Japanese acromegaly or gigantism patients, 53% reached the growth hormone target at Week 24 with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableGH target at Week 24
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90, or 120 mg · 24 weeksAs given in this study (human).
Measurements
Patients with serum GH below 2.5 ng/mL at Week 24
53%
lanreotide Autogel
Source sentences
Summary
Values at Week 24 were 53% for GH and 44% for IGF-I.
4 context sentences(design, population, supporting numbers)
Summary · context
Four weeks after the first injection, 41% of patients achieved serum GH level of <2.5 ng/mL and insulin-like growth factor-I (IGF-I) level was normalized in 31%.
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747703
04HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients, 44% normalized IGF-I at Week 24 with lanreotide.
In plain wordsIn Japanese acromegaly or gigantism patients, 44% reached normal IGF-I at Week 24 with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableIGF-I normalization at Week 24
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90, or 120 mg · 24 weeksAs given in this study (human).
Measurements
Patients with normalized IGF-I at Week 24
44%
lanreotide Autogel
Source sentences
Summary
Values at Week 24 were 53% for GH and 44% for IGF-I.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747704
05HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients given lanreotide Autogel 60, 90 or 120 mg, dose-dependent decreases in serum GH were observed.
In plain wordsIn Japanese acromegaly or gigantism patients, growth hormone decreased more with higher lanreotide doses.
Peptide
Lanreotide
Outcome
DecreaseDose-dependent GH decrease
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90, or 120 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
Dose-dependent decreases in serum GH and IGF-I levels were observed with dose-related changes in pharmacokinetic parameters.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747705
06HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients given lanreotide Autogel 60, 90 or 120 mg, dose-dependent decreases in serum IGF-I were observed.
In plain wordsIn Japanese acromegaly or gigantism patients, IGF-I decreased more with higher lanreotide doses.
Peptide
Lanreotide
Outcome
DecreaseDose-dependent IGF-I decrease
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90, or 120 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
Dose-dependent decreases in serum GH and IGF-I levels were observed with dose-related changes in pharmacokinetic parameters.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747706
07HumanNon-randomized trialPharmacokinetics
In Japanese acromegaly or pituitary gigantism patients, lanreotide pharmacokinetic parameters changed with dose.
In plain wordsIn Japanese acromegaly or gigantism patients, lanreotide pharmacokinetic measurements changed with dose.
Peptide
Lanreotide
Outcome
Direction not reportedDose-related pharmacokinetic changes
Study
n = 32
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
60, 90, or 120 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
Dose-dependent decreases in serum GH and IGF-I levels were observed with dose-related changes in pharmacokinetic parameters.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747707
08HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients, 47% had GH below 2.5 ng/mL at Week 52 with lanreotide.
In plain wordsIn Japanese acromegaly or gigantism patients, 47% reached the growth hormone target at Week 52 with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableGH target at Week 52
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
90 mg initially, adjusted to clinical response · 52 weeksAs given in this study (human).
Measurements
Patients with serum GH below 2.5 ng/mL at Week 52
47%
lanreotide Autogel long-term study
Source sentences
Summary
At Week 52, 47% of patients had serum GH levels of <2.5 ng/mL and 53% had normalized IGF-I level.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747708
09HumanNon-randomized trialEfficacy outcome
In Japanese acromegaly or pituitary gigantism patients, 53% normalized IGF-I at Week 52 with lanreotide.
In plain wordsIn Japanese acromegaly or gigantism patients, 53% reached normal IGF-I at Week 52 with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableIGF-I normalization at Week 52
Study
n = 32
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
90 mg initially, adjusted to clinical response · 52 weeksAs given in this study (human).
Measurements
Patients with normalized IGF-I
53%
Week 52, long-term study
Source sentences
Summary
At Week 52, 47% of patients had serum GH levels of <2.5 ng/mL and 53% had normalized IGF-I level.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747709
10HumanNon-randomized trialEfficacy outcome
In both Japanese studies, acromegaly symptoms improved during lanreotide treatment.
In plain wordsIn both Japanese studies, acromegaly symptoms improved during lanreotide treatment.
Peptide
Lanreotide
Outcome
Direction not reportedAcromegaly symptoms
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated
Source sentences
Summary
In both studies, acromegaly symptoms improved and treatment was generally well tolerated although gastrointestinal symptoms and injection site induration were reported.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747710
11HumanNon-randomized trialSafety outcome
In both Japanese studies, gastrointestinal symptoms occurred during lanreotide treatment.
In plain wordsIn both Japanese studies, patients reported digestive symptoms during lanreotide treatment.
Peptide
Lanreotide
Outcome
Not applicableGastrointestinal symptoms
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
In both studies, acromegaly symptoms improved and treatment was generally well tolerated although gastrointestinal symptoms and injection site induration were reported.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747711
12HumanNon-randomized trialSafety outcome
In both Japanese studies, injection site induration occurred during lanreotide treatment.
In plain wordsIn both Japanese studies, patients reported hardening at the injection site during lanreotide treatment.
Peptide
Lanreotide
Outcome
Not applicableInjection site induration
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
Dose not stated
Source sentences
Summary
In both studies, acromegaly symptoms improved and treatment was generally well tolerated although gastrointestinal symptoms and injection site induration were reported.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747712
13HumanNon-randomized trialSafety outcome
In both Japanese studies, lanreotide was generally well tolerated.
In plain wordsIn both Japanese studies, patients generally tolerated lanreotide well.
Peptide
Lanreotide
Outcome
Not applicableTolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
In both studies, acromegaly symptoms improved and treatment was generally well tolerated although gastrointestinal symptoms and injection site induration were reported.
3 context sentences(design, population, supporting numbers)
Summary · context
In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks.
Summary · context
In an open-label, long-term study, 32 patients (30 with acromegaly, 2 with pituitary gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections.
Summary · context
Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32.
Report a problemFND-2333747713

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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

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Efficacy, safety, and pharmacokinetics of sustained-release lanreotide (lanreotide Autogel) in Japanese patients with acromegaly or pituitary gigantism.

Summary

Results from this study13

Version history

Subjects

Publication types

MeSH terms