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Study · Non-randomized trial · n = 81 · 2016

14 results

Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study.

Bronstein MD, Fleseriu M, Neggers S, Colao A, Sheppard M, Gu F, Shen CC, Gadelha M, Farrall AJ, Hermosillo Reséndiz K, Ruffin M, Chen Y, Freda P

BMC endocrine disorders2 Apr 2016Cited by 62 (Europe PMC)

PMID27039081 (opens in a new tab)PMCIDPMC4818908 (opens in a new tab)DOI10.1186/s12902-016-0096-8 (opens in a new tab)PepBankPUB-27039081
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Summary

BackgroundMany patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues. A large, multicenter, randomized, Phase III core study demonstrated that pasireotide LAR had significantly superior efficacy over octreotide LAR. This analysis explores the efficacy and safety of switching therapeutic arms in inadequately controlled patients during a 12-month crossover extension.MethodsPatients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38). One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.ResultsTwelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure); 27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively; 44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively. Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28); 54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension. The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events.ConclusionsPasireotide LAR is a promising treatment option for patients with acromegaly inadequately controlled with the first-generation somatostatin analogue octreotide LAR.Trial registrationclinicaltrials.gov, NCT00600886 . Registered 14 January 2008.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 17.3% achieved GH below 2.5 μg/L and normal IGF-1 after switching to pasireotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 17.3% achieved biochemical control after switching to pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    Not applicableBiochemical control
    Study

    n = 81

    Analysis
    Primary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/28 days, with optional escalation to 60 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Biochemical control
    17.3%
    pasireotide

    Source sentences

    Summary
    Twelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure);
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  2. 02HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 0% achieved GH below 2.5 μg/L and normal IGF-1 after switching to octreotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 0% achieved biochemical control after switching to octreotide LAR.

    Peptide
    Octreotide
    Outcome
    Not applicableBiochemical control
    Study

    n = 38

    Analysis
    Primary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    20 mg/28 days, with optional escalation to 30 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Biochemical control
    0%
    octreotide

    Source sentences

    Summary
    Twelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure);
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  3. 03HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 27.2% achieved normal IGF-1 after switching to pasireotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 27.2% achieved normal IGF-1 after switching to pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    Not applicableNormal IGF-1
    Study

    n = 81

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/28 days, with optional escalation to 60 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Normal IGF-1
    27.2%
    pasireotide

    Source sentences

    Summary
    27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively;
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  4. 04HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 44.4% achieved GH below 2.5 μg/L after switching to pasireotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 44.4% achieved low GH after switching to pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    Not applicableGH below threshold
    Study

    n = 81

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/28 days, with optional escalation to 60 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    GH below threshold
    44.4%
    pasireotide

    Source sentences

    Summary
    44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  5. 05HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 5.3% achieved normal IGF-1 after switching to octreotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 5.3% achieved normal IGF-1 after switching to octreotide LAR.

    Peptide
    Octreotide
    Outcome
    Not applicableNormal IGF-1
    Study

    n = 38

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    20 mg/28 days, with optional escalation to 30 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Normal IGF-1
    5.3%
    octreotide

    Source sentences

    Summary
    27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively;
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  6. 06HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 23.7% achieved GH below 2.5 μg/L after switching to octreotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 23.7% achieved low GH after switching to octreotide LAR.

    Peptide
    Octreotide
    Outcome
    Not applicableGH below threshold
    Study

    n = 38

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    20 mg/28 days, with optional escalation to 30 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    GH below threshold
    23.7%
    octreotide

    Source sentences

    Summary
    44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  7. 07HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, tumor volume decreased a further 25% (SD 25) after switching to pasireotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, tumor volume decreased further from the core-study endpoint after switching to pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    DecreaseTumor volume change
    Study

    n: not reported in source

    Comparator
    end of core study
    Outcome group
    Tumor growth · Cancer
    Studied dose
    40 mg/28 days, with optional escalation to 60 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Tumor volume decrease
    25%
    pasireotide
    SD
    25%
    pasireotide

    Source sentences

    Summary
    Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28);
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  8. 08HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, tumor volume decreased a further 18% (SD 28) after switching to octreotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, tumor volume decreased further from the core-study endpoint after switching to octreotide LAR.

    Peptide
    Octreotide
    Outcome
    DecreaseTumor volume change
    Study

    n: not reported in source

    Comparator
    end of core study
    Outcome group
    Tumor growth · Cancer
    Studied dose
    20 mg/28 days, with optional escalation to 30 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Tumor volume decrease
    18%
    octreotide
    SD
    28%
    octreotide

    Source sentences

    Summary
    Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28);
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  9. 09HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 54.3% achieved at least 20% tumor-volume reduction during the extension after switching to pasireotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 54.3% achieved at least 20% tumor shrinkage after switching to pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    Not applicableTumor volume reduction responder
    Study

    n: not reported in source

    Outcome group
    Tumor growth · Cancer
    Studied dose
    40 mg/28 days, with optional escalation to 60 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Tumor-volume responders
    54.3%
    pasireotide

    Source sentences

    Summary
    54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  10. 10HumanNon-randomized trialEfficacy outcome

    In inadequately controlled acromegaly, 42.3% achieved at least 20% tumor-volume reduction during the extension after switching to octreotide LAR.

    In plain wordsIn patients with inadequately controlled acromegaly, 42.3% achieved at least 20% tumor shrinkage after switching to octreotide LAR.

    Peptide
    Octreotide
    Outcome
    Not applicableTumor volume reduction responder
    Study

    n: not reported in source

    Outcome group
    Tumor growth · Cancer
    Studied dose
    20 mg/28 days, with optional escalation to 30 mg/28 days · 12 monthsAs given in this study (human).

    Measurements

    Tumor-volume responders
    42.3%
    octreotide

    Source sentences

    Summary
    54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  11. 11HumanNon-randomized trialSafety outcome

    In acromegaly crossover patients, pasireotide and octreotide LAR had similar safety profiles except for hyperglycemia-related event frequency and degree.

    In plain wordsIn patients with acromegaly, pasireotide and octreotide LAR had similar safety profiles except for hyperglycemia-related events.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedSafety profile
    Study

    n: not reported in source

    Comparator
    octreotide LAR
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  12. 12HumanNon-randomized trialSafety outcome

    In acromegaly crossover patients, octreotide and pasireotide LAR had similar safety profiles except for hyperglycemia-related event frequency and degree.

    In plain wordsIn patients with acromegaly, octreotide and pasireotide LAR had similar safety profiles except for hyperglycemia-related events.

    Peptide
    Octreotide
    Outcome
    Direction not reportedSafety profile
    Study

    n: not reported in source

    Comparator
    pasireotide LAR
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  13. 13HumanNon-randomized trialSafety outcome

    In acromegaly crossover patients, hyperglycemia-related event frequency and degree differed between pasireotide and octreotide LAR, without a stated direction.

    In plain wordsIn patients with acromegaly, hyperglycemia-related events differed between pasireotide and octreotide LAR, but the abstract did not state the direction.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedHyperglycemia-related adverse events
    Study

    n: not reported in source

    Comparator
    octreotide LAR
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.
  14. 14HumanNon-randomized trialSafety outcome

    In acromegaly crossover patients, hyperglycemia-related event frequency and degree differed between octreotide and pasireotide LAR, without a stated direction.

    In plain wordsIn patients with acromegaly, hyperglycemia-related events differed between octreotide and pasireotide LAR, but the abstract did not state the direction.

    Peptide
    Octreotide
    Outcome
    Direction not reportedHyperglycemia-related adverse events
    Study

    n: not reported in source

    Comparator
    pasireotide LAR
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events.
    2 context sentences
    Summary · context
    Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38).
    Summary · context
    One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20.

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 postedNCT00600886

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Novartis Pharmaceuticalsn = 35811 Feb 2008 to 11 Mar 2016

Acromegaly

Trial pageClinicalTrials.govUpdated 2 Jul 2017

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.

  1. Version 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:36 UTC

    Study data updated · source update from Europe PMC

  3. 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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