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Study · Randomized controlled trial · n = 48 · 2002

7 results

Cardiovascular risk factors in acromegaly before and after normalization of serum IGF-I levels with the GH antagonist pegvisomant.

Sesmilo G, Fairfield WP, Katznelson L, Pulaski K, Freda PU, Bonert V, Dimaraki E, Stavrou S, Vance ML, Hayden D, Klibanski A

The Journal of clinical endocrinology and metabolism1 Apr 2002Cited by 83 (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 study7

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In acromegaly patients, pegvisomant showed no significant placebo differences in IL-6, homocysteine, glucose, insulin, triglyceride, total cholesterol, LDL cholesterol or HDL cholesterol.

    In plain wordsIn acromegaly patients, pegvisomant did not significantly change the listed inflammatory and metabolic markers compared with placebo.

    Outcome
    No significant changeOther inflammatory and metabolic markers
    Study

    n = 48

    Comparator
    Placebo
    Outcome group
    Cardiovascular Risk Markers · Cardiovascular
    Studied dose
    10, 15 or 20 mg daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no significant differences in IL-6, homocysteine, glucose, insulin, triglyceride, total cholesterol, LDL cholesterol and HDL cholesterol levels.
    2 context sentences
    Summary · context
    After baseline evaluation, patients with acromegaly were randomized to placebo (n = 14), 10 mg (n = 12), 15 mg (n = 10), or 20 mg (n = 12) daily pegvisomant for 12 wk.
    Summary · context
    The study consisted of 3 parts: a cross-sectional study, a prospective randomized 12-wk placebo-controlled study, and a longitudinal open-label study of up to 18 months of pegvisomant treatment.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with acromegaly, CRP increased with pegvisomant 20 mg compared with placebo (13.7 +/- 3.6 versus 0.5 +/- 3.3 mg/liter, P = 0.010).

    In plain wordsIn patients with acromegaly, pegvisomant 20 mg increased CRP more than placebo.

    Outcome
    IncreaseCRP versus placebo
    Study

    n = 26

    Comparator
    Placebo
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    20 mg daily · 12 weeksAs given in this study (human).

    Measurements

    CRP
    13.7 mg/liter
    pegvisomant 20 mg
    CRP
    0.5 mg/liter
    placebo

    Source sentences

    Summary
    In the placebo-controlled study, CRP increased in patients treated with 20 mg pegvisomant, compared with placebo (mean +/- SEM, 13.7 +/- 3.6 vs. 0.5 +/- 3.3 mg/liter; P = 0.010).
    2 context sentences
    Summary · context
    After baseline evaluation, patients with acromegaly were randomized to placebo (n = 14), 10 mg (n = 12), 15 mg (n = 10), or 20 mg (n = 12) daily pegvisomant for 12 wk.
    Summary · context
    The study consisted of 3 parts: a cross-sectional study, a prospective randomized 12-wk placebo-controlled study, and a longitudinal open-label study of up to 18 months of pegvisomant treatment.
  3. 03HumanNon-randomized trialEfficacy outcome

    In acromegaly patients during open-label pegvisomant treatment, CRP increased by 2.0 +/- 0.5 mg/liter (P = 0.0002).

    In plain wordsIn acromegaly patients, CRP increased compared with baseline during open-label pegvisomant treatment.

    Outcome
    IncreaseLongitudinal CRP change
    Study

    n: not reported in source

    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    At least 10 mg daily, adjusted to normalize IGF-I · Median 15.6 monthsAs given in this study (human).

    Measurements

    CRP change
    2 mg/liter
    longitudinal study

    Source sentences

    Summary
    In the longitudinal open-label study (median duration, 15.6 months), CRP increased by 2.0 +/- 0.5 mg/liter (P = 0.0002).
    2 context sentences
    Summary · context
    Subsequently, all patients received at least 10 mg pegvisomant daily for up to 18 months, with dose adjustments to achieve a normal IGF-I level.
    Summary · context
    The study consisted of 3 parts: a cross-sectional study, a prospective randomized 12-wk placebo-controlled study, and a longitudinal open-label study of up to 18 months of pegvisomant treatment.
  4. 04HumanNon-randomized trialEfficacy outcome

    In acromegaly patients during open-label pegvisomant treatment, total cholesterol increased by 0.22 +/- 0.11 mM (P = 0.050).

    In plain wordsIn acromegaly patients, total cholesterol increased compared with baseline during open-label pegvisomant treatment.

    Outcome
    IncreaseLongitudinal total cholesterol change
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    At least 10 mg daily, adjusted to normalize IGF-I · Median 15.6 monthsAs given in this study (human).

    Measurements

    Total cholesterol change
    0.22 mM
    longitudinal study

    Source sentences

    Summary
    Total cholesterol and triglycerides increased (0.22 +/- 0.11 mM, P = 0.050; and 0.25 +/- 0.09 mM, P = 0.007, respectively), whereas lipoprotein(a) decreased (-70 +/- 33 mg/liter, P = 0.039).
    3 context sentences
    Summary · context
    In the longitudinal open-label study (median duration, 15.6 months), CRP increased by 2.0 +/- 0.5 mg/liter (P = 0.0002).
    Summary · context
    Subsequently, all patients received at least 10 mg pegvisomant daily for up to 18 months, with dose adjustments to achieve a normal IGF-I level.
    Summary · context
    The study consisted of 3 parts: a cross-sectional study, a prospective randomized 12-wk placebo-controlled study, and a longitudinal open-label study of up to 18 months of pegvisomant treatment.
  5. 05HumanNon-randomized trialEfficacy outcome

    In acromegaly patients during open-label pegvisomant treatment, triglycerides increased by 0.25 +/- 0.09 mM (P = 0.007).

    In plain wordsIn acromegaly patients, triglycerides increased compared with baseline during open-label pegvisomant treatment.

    Outcome
    IncreaseLongitudinal triglyceride change
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    At least 10 mg daily, adjusted to normalize IGF-I · Median 15.6 monthsAs given in this study (human).

    Measurements

    Triglyceride change
    0.25 mM
    longitudinal study

    Source sentences

    Summary
    Total cholesterol and triglycerides increased (0.22 +/- 0.11 mM, P = 0.050; and 0.25 +/- 0.09 mM, P = 0.007, respectively), whereas lipoprotein(a) decreased (-70 +/- 33 mg/liter, P = 0.039).
    3 context sentences
    Summary · context
    In the longitudinal open-label study (median duration, 15.6 months), CRP increased by 2.0 +/- 0.5 mg/liter (P = 0.0002).
    Summary · context
    Subsequently, all patients received at least 10 mg pegvisomant daily for up to 18 months, with dose adjustments to achieve a normal IGF-I level.
    Summary · context
    The study consisted of 3 parts: a cross-sectional study, a prospective randomized 12-wk placebo-controlled study, and a longitudinal open-label study of up to 18 months of pegvisomant treatment.
  6. 06HumanNon-randomized trialEfficacy outcome

    In acromegaly patients during open-label pegvisomant treatment, lipoprotein(a) decreased by 70 +/- 33 mg/liter (P = 0.039).

    In plain wordsIn acromegaly patients, lipoprotein(a) decreased compared with baseline during open-label pegvisomant treatment.

    Outcome
    DecreaseLongitudinal lipoprotein(a) change
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    At least 10 mg daily, adjusted to normalize IGF-I · Median 15.6 monthsAs given in this study (human).

    Measurements

    Lipoprotein(a) change
    −70 mg/liter
    longitudinal study

    Source sentences

    Summary
    Total cholesterol and triglycerides increased (0.22 +/- 0.11 mM, P = 0.050; and 0.25 +/- 0.09 mM, P = 0.007, respectively), whereas lipoprotein(a) decreased (-70 +/- 33 mg/liter, P = 0.039).
    3 context sentences
    Summary · context
    In the longitudinal open-label study (median duration, 15.6 months), CRP increased by 2.0 +/- 0.5 mg/liter (P = 0.0002).
    Summary · context
    Subsequently, all patients received at least 10 mg pegvisomant daily for up to 18 months, with dose adjustments to achieve a normal IGF-I level.
    Summary · context
    The study consisted of 3 parts: a cross-sectional study, a prospective randomized 12-wk placebo-controlled study, and a longitudinal open-label study of up to 18 months of pegvisomant treatment.
  7. 07HumanNon-randomized trialEfficacy outcome

    In acromegaly patients during open-label pegvisomant treatment, glucose, insulin, homocysteine, HDL cholesterol and IL-6 did not change.

    In plain wordsIn acromegaly patients, the listed metabolic and inflammatory markers did not change from baseline during open-label pegvisomant treatment.

    Outcome
    No significant changeOther longitudinal metabolic and inflammatory markers
    Study

    n: not reported in source

    Outcome group
    Cardiovascular Risk Markers · Cardiovascular
    Studied dose
    At least 10 mg daily, adjusted to normalize IGF-I · Median 15.6 monthsAs given in this study (human).

    Source sentences

    Summary
    Glucose, insulin, homocysteine, HDL cholesterol, and IL-6 did not change.
    3 context sentences
    Summary · context
    In the longitudinal open-label study (median duration, 15.6 months), CRP increased by 2.0 +/- 0.5 mg/liter (P = 0.0002).
    Summary · context
    Subsequently, all patients received at least 10 mg pegvisomant daily for up to 18 months, with dose adjustments to achieve a normal IGF-I level.
    Summary · context
    The study consisted of 3 parts: a cross-sectional study, a prospective randomized 12-wk placebo-controlled study, and a longitudinal open-label study of up to 18 months of pegvisomant treatment.

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 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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