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Study · Non-randomized trial · n = 81 · 2019

11 results

Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study.

Fleseriu M, Petersenn S, Biller BMK, Kadioglu P, De Block C, T'Sjoen G, Vantyghem MC, Tauchmanova L, Wojna J, Roughton M, Lacroix A, Newell-Price J

Clinical endocrinology1 Oct 2019Cited by 30 (Europe PMC)

PMID31465533 (opens in a new tab)PMCIDPMC6899900 (opens in a new tab)DOI10.1111/cen.14081 (opens in a new tab)PepBankPUB-31465533
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanNon-randomized trialOther

    In Cushing's disease patients receiving pasireotide, 39/81 (48.1%) completed the extension, with median overall exposure of 23.9 months.

    In plain wordsIn Cushing's disease patients, 39 of 81 completed the pasireotide extension.

    Peptide
    Pasireotide
    Outcome
    Not applicableExtension completion
    Study

    n = 81

    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    Dose not stated · Median overall exposure 23.9 months at study endAs given in this study (human).

    Measurements

    Median overall exposure to pasireotide
    23.9 months
    at study end
    Patients who completed the extension
    39 patients
    of 81
    Proportion who completed the extension
    48.1%
    of 81 patients

    Source sentences

    Summary
    Median overall exposure to pasireotide at study end was 23.9 months; 39/81 (48.1%) patients completed the extension (received ≥ 12 months' treatment during the extension and could transit to a separate pasireotide safety study).
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  2. 02HumanNon-randomized trialEfficacy outcome

    In the pasireotide extension for Cushing's disease, mUFC was normal in 13/81 (16.0%) at month 36 versus 42/81 (51.9%) at extension baseline.

    In plain wordsDuring pasireotide treatment, normal urinary cortisol occurred in 13/81 patients at month 36 versus 42/81 at extension baseline.

    Peptide
    Pasireotide
    Outcome
    DecreasemUFC normalization at month 36
    Study

    n = 81

    Comparator
    Extension baseline
    Outcome group
    Endocrine Control · Endocrine and hormones
    Studied dose
    Dose not stated

    Measurements

    Patients with mUFC at or below ULN
    13 patients
    month 36, of 81
    Proportion with mUFC at or below ULN
    16%
    month 36
    Patients with mUFC at or below ULN
    42 patients
    extension baseline, of 81
    Proportion with mUFC at or below ULN
    51.9%
    extension baseline

    Source sentences

    Summary
    mUFC was ≤ULN in 42/81 (51.9%), 13/81 (16.0%) and 43/81 (53.1%) patients at extension baseline, month (M) 36 and last assessment.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  3. 03HumanNon-randomized trialEfficacy outcome

    In the pasireotide extension for Cushing's disease, mUFC was normal in 43/81 (53.1%) at last assessment.

    In plain wordsIn Cushing's disease patients, 43 of 81 had normal urinary cortisol at the last pasireotide assessment.

    Peptide
    Pasireotide
    Outcome
    Not applicablemUFC normalization at last assessment
    Study

    n = 81

    Outcome group
    Endocrine Control · Endocrine and hormones
    Studied dose
    Dose not stated

    Measurements

    Patients with mUFC at or below ULN
    43 patients
    last assessment, of 81
    Proportion with mUFC at or below ULN
    53.1%
    last assessment

    Source sentences

    Summary
    mUFC was ≤ULN in 42/81 (51.9%), 13/81 (16.0%) and 43/81 (53.1%) patients at extension baseline, month (M) 36 and last assessment.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  4. 04HumanNon-randomized trialEfficacy outcome

    In Cushing's disease patients receiving pasireotide, median mUFC remained within normal limits during the extension.

    In plain wordsIn Cushing's disease patients, median urinary cortisol stayed normal during the pasireotide extension.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedMedian mUFC
    Study

    n = 81

    Outcome group
    Endocrine Control · Endocrine and hormones
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Median mUFC remained within normal limits.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  5. 05HumanNon-randomized trialEfficacy outcome

    In Cushing's disease patients receiving pasireotide, clinical improvements persisted over time.

    In plain wordsIn Cushing's disease patients, clinical improvements persisted during pasireotide treatment.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedClinical improvements
    Study

    n = 81

    Outcome group
    Clinical Signs · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Clinical improvements were sustained over time.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  6. 06HumanNon-randomized trialOther

    In the pasireotide extension, 42 patients (51.9%) discontinued: 25 (30.9%) before month 24 and 17 (21.0%) after month 24.

    In plain wordsIn the pasireotide extension, 42 patients discontinued treatment.

    Peptide
    Pasireotide
    Outcome
    Not applicableDiscontinuation
    Study

    n = 81

    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    Dose not stated

    Measurements

    Patients who discontinued during the extension
    42 patients
    of 81
    Proportion who discontinued during the extension
    51.9%
    of 81 patients
    Patients who discontinued before month 24
    25 patients
    extension
    Proportion who discontinued before month 24
    30.9%
    extension
    Patients who discontinued after month 24
    17 patients
    extension
    Proportion who discontinued after month 24
    21%
    extension

    Source sentences

    Summary
    Forty-two (51.9%) patients discontinued during the extension: 25 (30.9%) before M24 and 17 (21.0%) after M24.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  7. 07HumanNon-randomized trialSafety outcome

    In Cushing's disease patients receiving pasireotide, hyperglycaemia-related adverse events occurred in 39.5% during the extension.

    In plain wordsIn the pasireotide extension, 39.5% of patients experienced adverse events related to high blood sugar.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycaemia-related adverse events
    Study

    n = 81

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Patients with hyperglycaemia-related adverse events
    39.5%
    extension

    Source sentences

    Summary
    Hyperglycaemia-related AEs occurred in 39.5% of patients.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  8. 08HumanNon-randomized trialSafety outcome

    In Cushing's disease patients receiving pasireotide, mean fasting glucose remained stable during the extension, with antidiabetic treatment initiated or escalated in some patients.

    In plain wordsDuring the pasireotide extension, fasting glucose stayed stable, with diabetes treatment started or increased in some patients.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedFasting glucose
    Study

    n = 81

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean fasting glucose (FPG) and glycated haemoglobin (HbA1c ) were stable during the extension, with antidiabetic medication initiated/escalated in some patients.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  9. 09HumanNon-randomized trialSafety outcome

    In Cushing's disease patients receiving pasireotide, mean glycated haemoglobin remained stable during the extension, with antidiabetic treatment initiated or escalated in some patients.

    In plain wordsDuring the pasireotide extension, average long-term blood sugar stayed stable, with diabetes treatment started or increased in some patients.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedHbA1c
    Study

    n = 81

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean fasting glucose (FPG) and glycated haemoglobin (HbA1c ) were stable during the extension, with antidiabetic medication initiated/escalated in some patients.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  10. 10HumanNon-randomized trialEfficacy outcome

    In Cushing's disease patients receiving pasireotide, median late-night salivary cortisol decreased from 2.6 × ULN at core baseline to 1.3 × ULN at month 36.

    In plain wordsIn Cushing's disease patients, late-night salivary cortisol decreased from baseline during pasireotide follow-up.

    Peptide
    Pasireotide
    Outcome
    DecreaseLate-night salivary cortisol
    Study

    n: not reported in source

    Outcome group
    Endocrine Control · Endocrine and hormones
    Studied dose
    Dose not stated

    Measurements

    Median late-night salivary cortisol
    2.6 × ULN
    core baseline
    Median late-night salivary cortisol
    1.3 × ULN
    month 36

    Source sentences

    Summary
    Median late-night salivary cortisol was 2.6 × ULN at core baseline and 1.3 × ULN at M36.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
  11. 11HumanNon-randomized trialSafety outcome

    In the pasireotide extension, diabetes classification increased from 66 (81.5%) at extension baseline to 71 (88.9%) at last assessment.

    In plain wordsDuring the pasireotide extension, more patients met diabetes criteria at the last assessment than at the start of the extension.

    Peptide
    Pasireotide
    Outcome
    IncreaseDiabetes classification
    Study

    n: not reported in source

    Comparator
    Extension baseline
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Patients classified as having diabetes
    66 patients
    extension baseline
    Proportion classified as having diabetes
    81.5%
    extension baseline
    Patients classified as having diabetes
    71 patients
    last assessment
    Proportion classified as having diabetes
    88.9%
    last assessment

    Source sentences

    Summary
    Sixty-six (81.5%) and 71 (88.9%) patients were classified as having diabetes (HbA1c  ≥ 6.5%, FPG ≥ 7.0 mmol/L, antidiabetic medication use, or history of diabetes) at extension baseline and last assessment.
    2 context sentences
    Summary · context
    Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
    Summary · context
    Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.

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 postedNCT01374906

Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

Novartis Pharmaceuticalsn = 1504 Nov 2011 to 21 Dec 2016

Cushing's Disease

Trial pageClinicalTrials.govUpdated 22 May 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.

  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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