Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study.

Colao A, Bronstein MD, Brue T, De Marinis L, Fleseriu M, Guitelman M, Raverot G, Shimon I, Fleck J, Gupta P, Pedroncelli AM, Gadelha MR

European journal of endocrinology1 Jun 2020Cited by 54 (Europe PMC)

PMID32217809PMCIDPMC7222286DOI10.1530/eje-19-0762PepBankPUB-32217809

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Summary

ObjectiveIn the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start. More patients achieved biochemical control with long-acting pasireotide versus continued treatment with octreotide/lanreotide (active control) at month 6. The current work assessed the extent of comorbidities at baseline and outcomes during a long-term extension.Design/methodsPatients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled. Uncontrolled patients on active control were switched to pasireotide 40 mg, with the dose increased at week 16 of the extension if still uncontrolled (crossover group). Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).ResultsAlmost half (49.5%; 98/198) of patients had ≥3 comorbidities at core baseline. During the extension, 173 patients received pasireotide. Pasireotide effectively and consistently reduced GH and IGF-I levels for up to 5.8 years' treatment; 37.0% of patients achieved GH <1.0 µg/L and normal IGF-I at some point during the core or extension. Improvements were observed in key symptoms. The long-term safety profile was similar to that in the core study; 23/173 patients discontinued treatment because of adverse events.ConclusionsIn this patient population with a high burden of comorbid illness, pasireotide was well tolerated and efficacious, providing prolonged maintenance of biochemical control and improving symptoms.

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

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanNon-randomized trialSafety outcome
In patients with acromegaly, 23/173 discontinued pasireotide because of adverse events.
In plain wordsIn patients with acromegaly, 23/173 stopped pasireotide because of adverse events.
Peptide
Pasireotide
Outcome
Not applicableDiscontinuation due to adverse events
Study
n = 173
Outcome group
Adverse events · Endocrine and hormones
Studied dose
40 or 60 mg · Up to 304 weeksAs given in this study (human).
Measurements
Patients discontinuing treatment because of adverse events
23 patients
of 173 patients in the extension
Source sentences
Summary
The long-term safety profile was similar to that in the core study; 23/173 patients discontinued treatment because of adverse events.
3 context sentences(design, population, supporting numbers)
Summary · context
In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start.
Summary · context
Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled.
Summary · context
Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
Show in the study text Report a problemFND-3221780905
02HumanNon-randomized trialSafety outcome
In patients with acromegaly, the long-term pasireotide safety profile was similar to that in the core study.
In plain wordsIn patients with acromegaly, pasireotide's long-term safety profile was similar to its profile in the core study.
Peptide
Pasireotide
Outcome
Direction not reportedLong-term safety profile
Study
n = 173
Comparator
Core study safety profile
Outcome group
Adverse events · Endocrine and hormones
Studied dose
40 or 60 mg · Up to 304 weeksAs given in this study (human).
Source sentences
Summary
The long-term safety profile was similar to that in the core study; 23/173 patients discontinued treatment because of adverse events.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled.
Summary · context
Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
Show in the study text Report a problemFND-3221780906
03HumanNon-randomized trialEfficacy outcome
In patients with uncontrolled acromegaly, pasireotide reduced GH levels for up to 5.8 years.
In plain wordsIn patients with acromegaly, pasireotide reduced growth hormone levels for up to 5.8 years.
Peptide
Pasireotide
Outcome
DecreaseGH levels
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 or 60 mg · Up to 304 weeksAs given in this study (human).
Source sentences
Summary
Pasireotide effectively and consistently reduced GH and IGF-I levels for up to 5.8 years' treatment; 37.0% of patients achieved GH <1.0 µg/L and normal IGF-I at some point during the core or extension.
3 context sentences(design, population, supporting numbers)
Summary · context
In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start.
Summary · context
Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled.
Summary · context
Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
Show in the study text Report a problemFND-3221780901
04HumanNon-randomized trialEfficacy outcome
In patients with uncontrolled acromegaly, pasireotide reduced IGF-I levels for up to 5.8 years.
In plain wordsIn patients with acromegaly, pasireotide reduced IGF-I levels for up to 5.8 years.
Peptide
Pasireotide
Outcome
DecreaseIGF-I levels
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 or 60 mg · Up to 304 weeksAs given in this study (human).
Source sentences
Summary
Pasireotide effectively and consistently reduced GH and IGF-I levels for up to 5.8 years' treatment; 37.0% of patients achieved GH <1.0 µg/L and normal IGF-I at some point during the core or extension.
3 context sentences(design, population, supporting numbers)
Summary · context
In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start.
Summary · context
Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled.
Summary · context
Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
Show in the study text Report a problemFND-3221780902
05HumanNon-randomized trialEfficacy outcome
In patients with acromegaly, 37.0% achieved GH below 1.0 µg/L and normal IGF-I at some point during the core or extension of pasireotide treatment.
In plain words37.0% of patients with acromegaly reached the study's hormone targets at some point during pasireotide treatment.
Peptide
Pasireotide
Outcome
Not applicableGH <1.0 µg/L with normal IGF-I
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 or 60 mg · Up to 304 weeksAs given in this study (human).
Measurements
Patients achieving GH <1.0 µg/L and normal IGF-I
37%
at some point during core or extension
Source sentences
Summary
Pasireotide effectively and consistently reduced GH and IGF-I levels for up to 5.8 years' treatment; 37.0% of patients achieved GH <1.0 µg/L and normal IGF-I at some point during the core or extension.
3 context sentences(design, population, supporting numbers)
Summary · context
In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start.
Summary · context
Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled.
Summary · context
Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
Show in the study text Report a problemFND-3221780903
06HumanNon-randomized trialEfficacy outcome
In patients with acromegaly, key symptoms improved during pasireotide treatment.
In plain wordsIn patients with acromegaly, key symptoms improved during pasireotide treatment.
Peptide
Pasireotide
Outcome
Direction not reportedKey symptoms
Study
n: not reported in source
Outcome group
Overall treatment effect · Endocrine and hormones
Studied dose
40 or 60 mg · Up to 304 weeksAs given in this study (human).
Source sentences
Summary
Improvements were observed in key symptoms.
3 context sentences(design, population, supporting numbers)
Summary · context
In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start.
Summary · context
Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled.
Summary · context
Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
Show in the study text Report a problemFND-3221780904

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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 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:36 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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