Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial.

Gadelha MR, Bronstein MD, Brue T, Coculescu M, Fleseriu M, Guitelman M, Pronin V, Raverot G, Shimon I, Lievre KK, Fleck J, Aout M, Pedroncelli AM, Colao A

The lancet. Diabetes & endocrinology24 Sept 2014Cited by 278 (Europe PMC)

PMID25260838DOI10.1016/s2213-8587(14)70169-xPepBankPUB-25260838

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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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In uncontrolled acromegaly, biochemical control occurred in ten (15%) with pasireotide 40 mg versus none with active control (difference 15.4%, 95% CI 7.6-26.5, p=0.0006).
In plain wordsIn uncontrolled acromegaly, 15% achieved biochemical control with pasireotide 40 mg versus none with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseBiochemical control
Study
n = 133
Comparator
Continued octreotide or lanreotide (pooled active control)
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Patients achieving biochemical control
10 patients
pasireotide 40 mg
Patients achieving biochemical control
15%
pasireotide 40 mg
Absolute difference from control
15.4%
pasireotide 40 mg vs active control
95% CI of difference
7.6 to 26.5%
pasireotide 40 mg vs active control
P value
0.0006 p-value
pasireotide 40 mg vs active control
Source sentences
Summary
At 24 weeks, ten (15%) patients in the pasireotide 40 mg group and 13 (20%) patients in the pasireotide 60 mg group achieved biochemical control, compared with no patients in the active control group (absolute difference from control group 15·4%, 95% CI 7·6-26·5, p=0·0006 for pasireotide 40 mg group…
3 context sentences(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Summary · context
Efficacy analyses were based on intention to treat.
Summary · context
Between Dec 17, 2010, and Aug 6, 2012, 198 patients were enrolled and randomly assigned to pasireotide 40 mg (n=65), pasireotide 60 mg (n=65), or active control (n=68) groups.
Report a problemFND-2526083801
02HumanRandomized controlled trialEfficacy outcome
In uncontrolled acromegaly, biochemical control occurred in 13 (20%) with pasireotide 60 mg versus none with active control (difference 20.0%, 95% CI 11.1-31.8, p<0.0001).
In plain wordsIn uncontrolled acromegaly, 20% achieved biochemical control with pasireotide 60 mg versus none with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseBiochemical control
Study
n = 133
Comparator
Continued octreotide or lanreotide (pooled active control)
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Patients achieving biochemical control
13 patients
pasireotide 60 mg
Patients achieving biochemical control
20%
pasireotide 60 mg
Absolute difference from control
20%
pasireotide 60 mg vs active control
95% CI of difference
11.1 to 31.8%
pasireotide 60 mg vs active control
P value
< 0.0001 p-value
pasireotide 60 mg vs active control
Source sentences
Summary
At 24 weeks, ten (15%) patients in the pasireotide 40 mg group and 13 (20%) patients in the pasireotide 60 mg group achieved biochemical control, compared with no patients in the active control group (absolute difference from control group 15·4%, 95% CI 7·6-26·5, p=0·0006 for pasireotide 40 mg group…
3 context sentences(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Summary · context
Efficacy analyses were based on intention to treat.
Summary · context
Between Dec 17, 2010, and Aug 6, 2012, 198 patients were enrolled and randomly assigned to pasireotide 40 mg (n=65), pasireotide 60 mg (n=65), or active control (n=68) groups.
Report a problemFND-2526083802
03HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, hyperglycaemia occurred in 21 (33%) with pasireotide 40 mg versus nine (14%) with active control.
In plain wordsIn uncontrolled acromegaly, high blood sugar occurred in 33% with pasireotide 40 mg versus 14% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseHyperglycaemia
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Adverse events · Endocrine and hormones
Studied dose
40 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Hyperglycaemia
21 patients
pasireotide 40 mg
Hyperglycaemia
33%
pasireotide 40 mg
Hyperglycaemia
9 patients
active control
Hyperglycaemia
14%
active control
Source sentences
Summary
The most common adverse events were hyperglycaemia (21 [33%] for treatment with 40 mg pasireotide, 19 [31%] with 60 mg pasireotide, and nine [14%] with active control), diabetes (13 [21%], 16 [26%], and five [8%]), and diarrhoea (ten [16%], 12 [19%], and three [5%]); most were grade 1 or 2 in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083803
04HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, hyperglycaemia occurred in 19 (31%) with pasireotide 60 mg versus nine (14%) with active control.
In plain wordsIn uncontrolled acromegaly, high blood sugar occurred in 31% with pasireotide 60 mg versus 14% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseHyperglycaemia
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Adverse events · Endocrine and hormones
Studied dose
60 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Hyperglycaemia
19 patients
pasireotide 60 mg
Hyperglycaemia
31%
pasireotide 60 mg
Hyperglycaemia
9 patients
active control
Hyperglycaemia
14%
active control
Source sentences
Summary
The most common adverse events were hyperglycaemia (21 [33%] for treatment with 40 mg pasireotide, 19 [31%] with 60 mg pasireotide, and nine [14%] with active control), diabetes (13 [21%], 16 [26%], and five [8%]), and diarrhoea (ten [16%], 12 [19%], and three [5%]); most were grade 1 or 2 in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083804
05HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, diabetes occurred in 13 (21%) with pasireotide 40 mg versus five (8%) with active control.
In plain wordsIn uncontrolled acromegaly, diabetes occurred in 21% with pasireotide 40 mg versus 8% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseDiabetes
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Adverse events · Endocrine and hormones
Studied dose
40 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Diabetes
13 patients
pasireotide 40 mg
Diabetes
21%
pasireotide 40 mg
Diabetes
5 patients
active control
Diabetes
8%
active control
Source sentences
Summary
The most common adverse events were hyperglycaemia (21 [33%] for treatment with 40 mg pasireotide, 19 [31%] with 60 mg pasireotide, and nine [14%] with active control), diabetes (13 [21%], 16 [26%], and five [8%]), and diarrhoea (ten [16%], 12 [19%], and three [5%]); most were grade 1 or 2 in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083805
06HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, diabetes occurred in 16 (26%) with pasireotide 60 mg versus five (8%) with active control.
In plain wordsIn uncontrolled acromegaly, diabetes occurred in 26% with pasireotide 60 mg versus 8% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseDiabetes
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Adverse events · Endocrine and hormones
Studied dose
60 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Diabetes
16 patients
pasireotide 60 mg
Diabetes
26%
pasireotide 60 mg
Diabetes
5 patients
active control
Diabetes
8%
active control
Source sentences
Summary
The most common adverse events were hyperglycaemia (21 [33%] for treatment with 40 mg pasireotide, 19 [31%] with 60 mg pasireotide, and nine [14%] with active control), diabetes (13 [21%], 16 [26%], and five [8%]), and diarrhoea (ten [16%], 12 [19%], and three [5%]); most were grade 1 or 2 in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083806
07HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, diarrhoea occurred in ten (16%) with pasireotide 40 mg versus three (5%) with active control.
In plain wordsIn uncontrolled acromegaly, diarrhea occurred in 16% with pasireotide 40 mg versus 5% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseDiarrhoea
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
40 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Diarrhoea
10 patients
pasireotide 40 mg
Diarrhoea
16%
pasireotide 40 mg
Diarrhoea
3 patients
active control
Diarrhoea
5%
active control
Source sentences
Summary
The most common adverse events were hyperglycaemia (21 [33%] for treatment with 40 mg pasireotide, 19 [31%] with 60 mg pasireotide, and nine [14%] with active control), diabetes (13 [21%], 16 [26%], and five [8%]), and diarrhoea (ten [16%], 12 [19%], and three [5%]); most were grade 1 or 2 in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083807
08HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, diarrhoea occurred in 12 (19%) with pasireotide 60 mg versus three (5%) with active control.
In plain wordsIn uncontrolled acromegaly, diarrhea occurred in 19% with pasireotide 60 mg versus 5% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseDiarrhoea
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
60 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Diarrhoea
12 patients
pasireotide 60 mg
Diarrhoea
19%
pasireotide 60 mg
Diarrhoea
3 patients
active control
Diarrhoea
5%
active control
Source sentences
Summary
The most common adverse events were hyperglycaemia (21 [33%] for treatment with 40 mg pasireotide, 19 [31%] with 60 mg pasireotide, and nine [14%] with active control), diabetes (13 [21%], 16 [26%], and five [8%]), and diarrhoea (ten [16%], 12 [19%], and three [5%]); most were grade 1 or 2 in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083808
09HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, serious adverse events occurred in six (10%) with pasireotide 40 mg versus three (5%) with active control.
In plain wordsIn uncontrolled acromegaly, serious adverse events occurred in 10% with pasireotide 40 mg versus 5% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
IncreaseSerious adverse events
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Adverse events · Whole body
Studied dose
40 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Serious adverse events
6 patients
pasireotide 40 mg
Serious adverse events
10%
pasireotide 40 mg
Serious adverse events
3 patients
active control
Serious adverse events
5%
active control
Source sentences
Summary
Serious adverse events were reported in six (10%) patients in the pasireotide 40 mg group, two (3%) in the pasireotide 60 mg group, and three (5%) in the active control group.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083809
10HumanRandomized controlled trialSafety outcome
In uncontrolled acromegaly, serious adverse events occurred in two (3%) with pasireotide 60 mg versus three (5%) with active control.
In plain wordsIn uncontrolled acromegaly, serious adverse events occurred in 3% with pasireotide 60 mg versus 5% with continued octreotide or lanreotide.
Peptide
Pasireotide
Outcome
DecreaseSerious adverse events
Study
n: not reported in source
Comparator
Continued octreotide or lanreotide (pooled active control)
Outcome group
Adverse events · Whole body
Studied dose
60 mg every 28 days · 24 weeksAs given in this study (human).
Measurements
Serious adverse events
2 patients
pasireotide 60 mg
Serious adverse events
3%
pasireotide 60 mg
Serious adverse events
3 patients
active control
Serious adverse events
5%
active control
Source sentences
Summary
Serious adverse events were reported in six (10%) patients in the pasireotide 40 mg group, two (3%) in the pasireotide 60 mg group, and three (5%) in the active control group.
1 context sentence(design, population, supporting numbers)
Summary · context
We randomly assigned patients in a 1:1:1 ratio with an interactive voice-web response system to receive 40 mg pasireotide long-acting release once every 28 days for 24 weeks, 60 mg pasireotide long-acting release once every 28 days for 24 weeks, or continued treatment with octreotide or lanreotide (active control).
Report a problemFND-2526083810

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01137682

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Novartis Pharmaceuticalsn = 19819 Jul 2010 to 28 Feb 2017

Acromegaly

Trial page ClinicalTrials.govUpdated 5 Apr 2018

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 4Current
28 Oct 2026, 02:03 UTC
Study results updated
Versions 2 to 3
27 Oct 2026, 16:36 UTC
The same notice was added 2 times, first on 27 Oct 2026, 16:36 UTC. The status did not change between them.
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC