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Study · Randomized controlled trial · n = 56 · 2009

5 results

A randomized, controlled, multicentre trial comparing pegvisomant alone with combination therapy of pegvisomant and long-acting octreotide in patients with acromegaly.

Trainer PJ, Ezzat S, D'Souza GA, Layton G, Strasburger CJ

Clinical endocrinology2 May 2009Cited by 95 (Europe PMC)

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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In acromegaly suboptimally controlled on octreotide LAR, the number of adverse events did not differ between pegvisomant plus octreotide LAR and pegvisomant monotherapy.

    In plain wordsIn acromegaly, adverse event numbers did not differ between pegvisomant plus octreotide and pegvisomant alone.

    Peptide
    Octreotide
    Outcome
    No significant changeAdverse event number
    Study

    n = 56

    Comparator
    pegvisomant monotherapy
    Analysis
    Primary
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated · 40 weeksAs given in this study (human).

    Source sentences

    Summary
    PM and P-LAR were well tolerated and there were no differences in the number of AEs.
    1 context sentence
    Summary · context
    This was an open-label, multicentre, randomized, 40-week outpatient study.
  2. 02HumanRandomized controlled trialSafety outcome

    In acromegaly, pegvisomant-octreotide tended toward more clinically significant transaminase increases than pegvisomant alone, especially with high-dose octreotide.

    In plain wordsIn acromegaly, pegvisomant-octreotide tended toward more liver enzyme increases than pegvisomant alone, especially with high-dose octreotide.

    Peptide
    Octreotide
    Outcome
    IncreaseHepatic transaminase increases
    Study

    n = 56

    Comparator
    pegvisomant monotherapy
    Analysis
    Primary
    Outcome group
    Adverse events · Liver
    Studied dose
    Dose not stated · 40 weeksAs given in this study (human).

    Source sentences

    Summary
    Patients receiving P-LAR tended to be more likely to have clinically significant increases in hepatic transaminase levels, especially those receiving high-dose LAR.
    1 context sentence
    Summary · context
    This was an open-label, multicentre, randomized, 40-week outpatient study.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In acromegaly, IGF-I normalization was similar with pegvisomant-octreotide (62%) and pegvisomant alone (56%).

    In plain wordsIn acromegaly, IGF-I normalization was similar with pegvisomant-octreotide and pegvisomant alone, despite a numerically higher combination rate.

    Peptide
    Octreotide
    Outcome
    IncreaseIGF-I normalization
    Study

    n = 56

    Comparator
    pegvisomant monotherapy
    Analysis
    Secondary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Dose not stated · 40 weeksAs given in this study (human).

    Measurements

    IGF-I normalization
    56%
    pegvisomant monotherapy
    IGF-I normalization
    62%
    pegvisomant plus octreotide LAR

    Source sentences

    Summary
    Normalization of IGF-I was similar with both regimens (56% and 62% of patients for PM and P-LAR respectively).
    1 context sentence
    Summary · context
    This was an open-label, multicentre, randomized, 40-week outpatient study.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In acromegaly, fasting glucose fell less with pegvisomant-octreotide than pegvisomant alone, which had a -0.8 mmol/l difference (95% CI -1.16, -0.53).

    In plain wordsIn acromegaly, fasting glucose fell less with pegvisomant-octreotide than pegvisomant alone.

    Peptide
    Octreotide
    Outcome
    IncreaseFasting glucose level change
    Study

    n = 56

    Comparator
    pegvisomant monotherapy
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 40 weeksAs given in this study (human).

    Measurements

    Difference in fasting glucose reduction (PM minus P-LAR)
    −0.8 mmol/l
    pegvisomant monotherapy versus pegvisomant plus octreotide LAR
    95% CI of difference in fasting glucose reduction
    −1.16 to −0.53 mmol/l
    pegvisomant monotherapy versus pegvisomant plus octreotide LAR

    Source sentences

    Summary
    Reductions in fasting glucose levels were greater with PM than with P-LAR (-0.8 mmol/l; 95% confidence interval -1.16, -0.53 mmol/l).
    1 context sentence
    Summary · context
    This was an open-label, multicentre, randomized, 40-week outpatient study.
  5. 05HumanNon-randomized trialEfficacy outcome

    In suboptimally controlled acromegaly, pegvisomant monotherapy normalized IGF-I in 56% of patients.

    In plain wordsIn suboptimally controlled acromegaly, pegvisomant alone normalized IGF-I in 56% of patients.

    Outcome
    Not applicableIGF-I normalization with monotherapy
    Study

    n = 27

    Analysis
    Secondary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    10 mg once daily initially, adjusted in 5-mg increments every 8 weeks · 40 weeksAs given in this study (human).

    Measurements

    IGF-I normalization
    56%
    pegvisomant monotherapy arm

    Source sentences

    Summary
    Normalization of IGF-I was similar with both regimens (56% and 62% of patients for PM and P-LAR respectively).
    1 context sentence
    Summary · context
    This was an open-label, multicentre, randomized, 40-week outpatient study.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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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