High-dose intramuscular octreotide in patients with acromegaly inadequately controlled on conventional somatostatin analogue therapy: a randomised controlled trial.

Giustina A, Bonadonna S, Bugari G, Colao A, Cozzi R, Cannavo S, de Marinis L, Degli Uberti E, Bogazzi F, Mazziotti G, Minuto F, Montini M, Ghigo E

European journal of endocrinology22 May 2009Cited by 91 (Europe PMC)

PMID19465485DOI10.1530/eje-09-0372PepBankPUB-19465485

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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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In uncontrolled acromegaly, week 24 IGF1 reduction occurred in 10/11 high-dose versus 8/15 high-frequency octreotide patients (P<0.05).
In plain wordsIn uncontrolled acromegaly, more patients had IGF1 reductions with high-dose than high-frequency octreotide.
Peptide
Octreotide
Outcome
IncreaseIGF1 reduction responders
Study
n = 26
Comparator
Octreotide 30 mg/21 days
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60 mg/28 days · intramuscular · 24 weeksAs given in this study (human).
Measurements
Patients with week 24 IGF1 reduction
10 patients
high-dose group, of 11
Patients with week 24 IGF1 reduction
8 patients
high-frequency group, of 15
P value
< 0.05 P
high-dose versus high-frequency
Source sentences
Summary
Significantly, more patients (10 out of 11) achieved week 24 IGF1 reduction in the high-dose than the high-frequency group (8 out of 15; P<0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy.
Summary · context
Patients with > or =50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 days) octreotide i.m. injection.
Report a problemFND-1946548501
02HumanRandomized controlled trialEfficacy outcome
In uncontrolled acromegaly, IGF1 normalized only with high-dose octreotide (4/11; P=0.02).
In plain wordsIn uncontrolled acromegaly, IGF1 normalized only with high-dose octreotide.
Peptide
Octreotide
Outcome
IncreaseIGF1 normalization
Study
n = 26
Comparator
High-frequency octreotide
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60 mg/28 days · intramuscular · 24 weeksAs given in this study (human).
Measurements
Patients with IGF1 normalisation
4 patients
high-dose group, of 11
P value
0.02 P
high-dose regimen
Source sentences
Summary
Normalisation of IGF1 occurred only with the high-dose regimen (4/11; P=0.02).
2 context sentences(design, population, supporting numbers)
Summary · context
A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy.
Summary · context
Patients with > or =50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 days) octreotide i.m. injection.
Report a problemFND-1946548503
03HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, safety parameters were similar between octreotide regimens except HbA1c.
In plain wordsIn uncontrolled acromegaly, safety results were similar between octreotide regimens except HbA1c.
Peptide
Octreotide
Outcome
Direction not reportedSafety parameters
Study
n: not reported in source
Comparator
High-dose versus high-frequency octreotide
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intramuscular · 24 weeksAs given in this study (human).
Source sentences
Summary
Safety parameters were similar between treatment groups, apart from a slight decrease in HbA1c in the high-dose group only.
2 context sentences(design, population, supporting numbers)
Summary · context
A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy.
Summary · context
Patients with > or =50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 days) octreotide i.m. injection.
Report a problemFND-1946548507
04HumanNon-randomized trialEfficacy outcome
In uncontrolled acromegaly, high-dose octreotide reduced IGF1 at week 24 versus baseline (P=0.02).
In plain wordsIn uncontrolled acromegaly, high-dose octreotide reduced IGF1 from baseline.
Peptide
Octreotide
Outcome
DecreaseIGF1 change
Study
n = 11
Comparator
Baseline
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60 mg/28 days · intramuscular · 24 weeksAs given in this study (human).
Measurements
P value
0.02 P
week 24 IGF1 versus baseline, high-dose group
Source sentences
Summary
In the high-dose group only, week-24 IGF1 values were significantly reduced (P=0.02) versus baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy.
Summary · context
Patients with > or =50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 days) octreotide i.m. injection.
Report a problemFND-1946548502
05HumanNon-randomized trialSafety outcome
In uncontrolled acromegaly, 14 octreotide-treated patients experienced adverse events.
In plain wordsIn uncontrolled acromegaly, 14 octreotide-treated patients had adverse events.
Peptide
Octreotide
Outcome
Not applicableAdverse events
Study
n: not reported in source
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intramuscular · 24 weeksAs given in this study (human).
Measurements
Patients experiencing adverse events
14 patients
trial population
Source sentences
Summary
Out of 14 patients experiencing adverse events, 5 reported drug-related gastrointestinal effects.
2 context sentences(design, population, supporting numbers)
Summary · context
A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy.
Summary · context
Patients with > or =50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 days) octreotide i.m. injection.
Report a problemFND-1946548504
06HumanNon-randomized trialSafety outcome
In uncontrolled acromegaly, 5 of 14 patients with adverse events reported drug-related gastrointestinal effects during octreotide treatment.
In plain wordsIn uncontrolled acromegaly, five octreotide-treated patients reported drug-related digestive effects.
Peptide
Octreotide
Outcome
Not applicableDrug-related gastrointestinal effects
Study
n: not reported in source
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · intramuscular · 24 weeksAs given in this study (human).
Measurements
Patients with drug-related gastrointestinal effects
5 patients
of 14 patients with adverse events
Source sentences
Summary
Out of 14 patients experiencing adverse events, 5 reported drug-related gastrointestinal effects.
2 context sentences(design, population, supporting numbers)
Summary · context
A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy.
Summary · context
Patients with > or =50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 days) octreotide i.m. injection.
Report a problemFND-1946548505
07HumanNon-randomized trialSafety outcome
In uncontrolled acromegaly, HbA1c decreased slightly only in the high-dose octreotide group.
In plain wordsIn uncontrolled acromegaly, HbA1c decreased slightly only with high-dose octreotide.
Peptide
Octreotide
Outcome
DecreaseHbA1c
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
60 mg/28 days · intramuscular · 24 weeksAs given in this study (human).
Source sentences
Summary
Safety parameters were similar between treatment groups, apart from a slight decrease in HbA1c in the high-dose group only.
2 context sentences(design, population, supporting numbers)
Summary · context
A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy.
Summary · context
Patients with > or =50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 days) octreotide i.m. injection.
Report a problemFND-1946548508

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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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