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Study · Non-randomized trial · n = 29 · 2009

6 results

Treatment of pituitary-dependent Cushing's disease with the multireceptor ligand somatostatin analog pasireotide (SOM230): a multicenter, phase II trial.

Boscaro M, Ludlam WH, Atkinson B, Glusman JE, Petersenn S, Reincke M, Snyder P, Tabarin A, Biller BM, Findling J, Melmed S, Darby CH and 6 more

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Hu K, Wang Y, Freda PU, Grossman AB, Frohman LA, Bertherat J

The Journal of clinical endocrinology and metabolism28 Oct 2008Cited by 183 (Europe PMC)

PMID18957506 (opens in a new tab)DOI10.1210/jc.2008-1008 (opens in a new tab)PepBankPUB-18957506
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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 study6

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

  1. 01HumanNon-randomized trialEfficacy outcome

    In patients with Cushing's disease, five of 29 (17%) achieved normal UFC after 15 days of pasireotide.

    In plain wordsIn patients with Cushing's disease, 17% achieved normal urinary cortisol after 15 days of pasireotide.

    Peptide
    Pasireotide
    Outcome
    DecreaseUFC normalization
    Study

    n = 29

    Analysis
    Primary
    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    600 microg twice daily · subcutaneous · 15 daysAs given in this study (human).

    Measurements

    Patients with normal UFC (responders)
    5 patients
    primary efficacy analysis, n=29
    Patients with normal UFC (responders)
    17%
    primary efficacy analysis, n=29

    Source sentences

    Summary
    Of the 29 patients in the primary efficacy analysis, 22 (76%) showed a reduction in UFC levels, of whom five (17%) had normal UFC levels (responders), after 15 d of treatment with pasireotide.
    3 context sentences
    Summary · context
    We conducted a phase II, proof-of-concept, open-label, single-arm, 15-d multicenter study.
    Summary · context
    Thirty-nine patients with either de novo Cushing's disease who were candidates for pituitary surgery or with persistent or recurrent Cushing's disease after surgery without having received prior pituitary irradiation.
    Summary · context
    Patients self-administered sc pasireotide 600 microg twice daily for 15 d.
  2. 02HumanNon-randomized trialEfficacy outcome

    In patients with Cushing's disease, 22 of 29 (76%) had reduced UFC after 15 days of pasireotide.

    In plain wordsIn patients with Cushing's disease, 76% had reduced urinary cortisol after 15 days of pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    DecreaseUFC reduction responders
    Study

    n = 29

    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    600 microg twice daily · subcutaneous · 15 daysAs given in this study (human).

    Measurements

    Patients with reduced UFC
    22 patients
    primary efficacy analysis, n=29
    Patients with reduced UFC
    76%
    primary efficacy analysis, n=29

    Source sentences

    Summary
    Of the 29 patients in the primary efficacy analysis, 22 (76%) showed a reduction in UFC levels, of whom five (17%) had normal UFC levels (responders), after 15 d of treatment with pasireotide.
    3 context sentences
    Summary · context
    We conducted a phase II, proof-of-concept, open-label, single-arm, 15-d multicenter study.
    Summary · context
    Thirty-nine patients with either de novo Cushing's disease who were candidates for pituitary surgery or with persistent or recurrent Cushing's disease after surgery without having received prior pituitary irradiation.
    Summary · context
    Patients self-administered sc pasireotide 600 microg twice daily for 15 d.
  3. 03HumanNon-randomized trialEfficacy outcome

    In patients with Cushing's disease, serum cortisol decreased during pasireotide treatment.

    In plain wordsIn patients with Cushing's disease, blood cortisol decreased during pasireotide treatment compared with baseline.

    Peptide
    Pasireotide
    Outcome
    DecreaseSerum cortisol
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    600 microg twice daily · subcutaneous · 15 daysAs given in this study (human).

    Source sentences

    Summary
    Serum cortisol levels and plasma ACTH levels were also reduced.
    3 context sentences
    Summary · context
    We conducted a phase II, proof-of-concept, open-label, single-arm, 15-d multicenter study.
    Summary · context
    Thirty-nine patients with either de novo Cushing's disease who were candidates for pituitary surgery or with persistent or recurrent Cushing's disease after surgery without having received prior pituitary irradiation.
    Summary · context
    Patients self-administered sc pasireotide 600 microg twice daily for 15 d.
  4. 04HumanNon-randomized trialEfficacy outcome

    In patients with Cushing's disease, plasma ACTH decreased during pasireotide treatment.

    In plain wordsIn patients with Cushing's disease, blood ACTH decreased during pasireotide treatment compared with baseline.

    Peptide
    Pasireotide
    Outcome
    DecreasePlasma ACTH
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    600 microg twice daily · subcutaneous · 15 daysAs given in this study (human).

    Source sentences

    Summary
    Serum cortisol levels and plasma ACTH levels were also reduced.
    3 context sentences
    Summary · context
    We conducted a phase II, proof-of-concept, open-label, single-arm, 15-d multicenter study.
    Summary · context
    Thirty-nine patients with either de novo Cushing's disease who were candidates for pituitary surgery or with persistent or recurrent Cushing's disease after surgery without having received prior pituitary irradiation.
    Summary · context
    Patients self-administered sc pasireotide 600 microg twice daily for 15 d.
  5. 05HumanNon-randomized trialPharmacokinetics

    In patients with Cushing's disease, pasireotide steady-state plasma concentrations were achieved within 5 days.

    In plain wordsIn patients with Cushing's disease, pasireotide blood concentrations stabilized within five days.

    Peptide
    Pasireotide
    Outcome
    Not applicableTime to steady state
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    600 microg twice daily · subcutaneous · 15 daysAs given in this study (human).

    Measurements

    Time to steady-state plasma concentration
    ≤ 5 days
    pasireotide 600 microg twice daily

    Source sentences

    Summary
    Steady-state plasma concentrations of pasireotide were achieved within 5 d of treatment.
    3 context sentences
    Summary · context
    We conducted a phase II, proof-of-concept, open-label, single-arm, 15-d multicenter study.
    Summary · context
    Thirty-nine patients with either de novo Cushing's disease who were candidates for pituitary surgery or with persistent or recurrent Cushing's disease after surgery without having received prior pituitary irradiation.
    Summary · context
    Patients self-administered sc pasireotide 600 microg twice daily for 15 d.
  6. 06HumanObservational studyPharmacokinetics

    In patients with Cushing's disease, responders appeared to have higher pasireotide exposure than nonresponders.

    In plain wordsIn patients with Cushing's disease, response appeared linked to higher pasireotide exposure than in nonresponders.

    Peptide
    Pasireotide
    Outcome
    IncreaseExposure by response status
    Study

    n: not reported in source

    Comparator
    nonresponders
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    600 microg twice daily · subcutaneous · 15 daysAs given in this study (human).

    Source sentences

    Summary
    Responders appeared to have higher pasireotide exposure than nonresponders.
    3 context sentences
    Summary · context
    We conducted a phase II, proof-of-concept, open-label, single-arm, 15-d multicenter study.
    Summary · context
    Thirty-nine patients with either de novo Cushing's disease who were candidates for pituitary surgery or with persistent or recurrent Cushing's disease after surgery without having received prior pituitary irradiation.
    Summary · context
    Patients self-administered sc pasireotide 600 microg twice daily for 15 d.

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 stopped early · source ClinicalTrials.gov (opens in a new tab)

WithdrawnPhase 2NCT03053284

Pasireotide in Hyperinsulinemic Hypoglycemia

Montefiore Medical Centern = 0est. Apr 2017 to est. Apr 2018

Congenital Hyperinsulinism · Insulinoma · Hyperinsulinism

Trial pageClinicalTrials.govUpdated 14 May 2021

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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