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Study · Non-randomized trial · n = 33 · 2017

16 results

Efficacy and safety of long-acting pasireotide in Japanese patients with acromegaly or pituitary gigantism: results from a multicenter, open-label, randomized, phase 2 study.

Tahara S, Murakami M, Kaneko T, Shimatsu A

Endocrine journal8 Jul 2017Cited by 24 (Europe PMC)

PMID28592706 (opens in a new tab)DOI10.1507/endocrj.ej16-0624 (opens in a new tab)PepBankPUB-28592706
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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 study16

16 results from studies that gave the peptide. 16 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In Japanese patients with acromegaly or pituitary gigantism, pasireotide produced biochemical control in 18.2% at month 3 (6/33, 90% CI 8.2%-32.8%).

    In plain wordsIn Japanese patients with acromegaly or pituitary gigantism, 18.2% achieved biochemical control at month 3 with pasireotide.

    Peptide
    Pasireotide
    Outcome
    Not applicableBiochemical control at month 3
    Study

    n = 33

    Analysis
    Primary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Biochemical control at month 3
    18.2%
    all 33 patients, pooled dose arms
    Patients with biochemical control at month 3
    6 patients
    of 33
    90% CI, biochemical control at month 3
    8.2 to 32.8%
    all patients

    Source sentences

    Summary
    At month 3, 18.2% of patients (6/33; 90% confidence interval: 8.2%, 32.8%)
    3 context sentences
    Summary · context
    Primary end point was the proportion of all patients who achieved biochemical control (mean growth hormone [GH] levels<2.5μg/L and normalized insulin-like growth factor-1 [IGF-1]) at month 3.
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  2. 02HumanNon-randomized trialEfficacy outcome

    In Japanese patients receiving pasireotide, including one patient with low IGF-1 increased the month 3 control proportion to 21.2% (7/33).

    In plain wordsIn Japanese patients receiving pasireotide, the control proportion was 21.2% when a patient with low IGF-1 was included.

    Peptide
    Pasireotide
    Outcome
    Not applicableControl including low IGF-1
    Study

    n = 33

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Control including a patient with low IGF-1, month 3
    21.2%
    all 33 patients, pooled dose arms
    Patients with control including low IGF-1, month 3
    7 patients
    of 33

    Source sentences

    Summary
    At month 3, 18.2% of patients (6/33; 90% confidence interval: 8.2%, 32.8%) had biochemical control (21.2% [7/33] when including a patient with mean GH<2.5μg/L and IGF-1< lower limit of normal).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  3. 03HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, three discontinued for adverse events: diabetes mellitus, hyperglycemia, and abnormal liver function, one each.

    In plain wordsIn Japanese patients receiving pasireotide, three stopped treatment for adverse events, with one each for diabetes, high glucose, and abnormal liver function.

    Peptide
    Pasireotide
    Outcome
    Not applicableAdverse event discontinuations
    Study

    n = 33

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients discontinuing treatment due to adverse events
    3 patients
    diabetes mellitus, hyperglycemia, liver function abnormality, n=1 each

    Source sentences

    Summary
    Twenty-nine patients completed the 12-month core phase, 1 withdrew consent, and 3 discontinued treatment due to adverse events (AEs; diabetes mellitus, hyperglycemia, liver function abnormality, n=1 each).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  4. 04HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, one discontinued treatment because of diabetes mellitus.

    In plain wordsIn Japanese patients receiving pasireotide, one stopped treatment because of diabetes.

    Peptide
    Pasireotide
    Outcome
    Not applicableDiscontinuation for diabetes mellitus
    Study

    n = 33

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients discontinuing treatment due to diabetes mellitus
    1 patients
    adverse event discontinuation

    Source sentences

    Summary
    Twenty-nine patients completed the 12-month core phase, 1 withdrew consent, and 3 discontinued treatment due to adverse events (AEs; diabetes mellitus, hyperglycemia, liver function abnormality, n=1 each).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  5. 05HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, one discontinued treatment because of hyperglycemia.

    In plain wordsIn Japanese patients receiving pasireotide, one stopped treatment because of high blood glucose.

    Peptide
    Pasireotide
    Outcome
    Not applicableDiscontinuation for hyperglycemia
    Study

    n = 33

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients discontinuing treatment due to hyperglycemia
    1 patients
    adverse event discontinuation

    Source sentences

    Summary
    Twenty-nine patients completed the 12-month core phase, 1 withdrew consent, and 3 discontinued treatment due to adverse events (AEs; diabetes mellitus, hyperglycemia, liver function abnormality, n=1 each).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  6. 06HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, one discontinued treatment because of abnormal liver function.

    In plain wordsIn Japanese patients receiving pasireotide, one stopped treatment because of abnormal liver function.

    Peptide
    Pasireotide
    Outcome
    Not applicableDiscontinuation for liver function abnormality
    Study

    n = 33

    Outcome group
    Adverse events · Liver
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients discontinuing treatment due to liver function abnormality
    1 patients
    adverse event discontinuation

    Source sentences

    Summary
    Twenty-nine patients completed the 12-month core phase, 1 withdrew consent, and 3 discontinued treatment due to adverse events (AEs; diabetes mellitus, hyperglycemia, liver function abnormality, n=1 each).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  7. 07HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, 32/33 (97%) experienced adverse events.

    In plain wordsIn Japanese patients receiving pasireotide, 97% experienced adverse events.

    Peptide
    Pasireotide
    Outcome
    Not applicableAny adverse event
    Study

    n = 33

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with any adverse event
    97%
    32/33 patients
    Patients with any adverse event
    32 patients
    of 33 patients

    Source sentences

    Summary
    Almost all patients (97%; 32/33) experienced AEs;
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  8. 08HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, nasopharyngitis occurred in 48.5%.

    In plain wordsIn Japanese patients receiving pasireotide, 48.5% developed nose and throat inflammation.

    Peptide
    Pasireotide
    Outcome
    Not applicableNasopharyngitis
    Study

    n = 33

    Outcome group
    Adverse events · Respiratory
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with nasopharyngitis
    48.5%
    most common adverse events

    Source sentences

    Summary
    Almost all patients (97%; 32/33) experienced AEs; the most common AEs were nasopharyngitis (48.5%), hyperglycemia (42.4%), diabetes mellitus (24.2%), constipation (18.2%), and hypoglycemia (15.2%).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  9. 09HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, hyperglycemia occurred in 42.4%.

    In plain wordsIn Japanese patients receiving pasireotide, 42.4% developed high blood glucose.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycemia
    Study

    n = 33

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with hyperglycemia
    42.4%
    most common adverse events

    Source sentences

    Summary
    Almost all patients (97%; 32/33) experienced AEs; the most common AEs were nasopharyngitis (48.5%), hyperglycemia (42.4%), diabetes mellitus (24.2%), constipation (18.2%), and hypoglycemia (15.2%).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  10. 10HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, diabetes mellitus occurred in 24.2%.

    In plain wordsIn Japanese patients receiving pasireotide, 24.2% developed diabetes.

    Peptide
    Pasireotide
    Outcome
    Not applicableDiabetes mellitus
    Study

    n = 33

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with diabetes mellitus
    24.2%
    most common adverse events

    Source sentences

    Summary
    Almost all patients (97%; 32/33) experienced AEs; the most common AEs were nasopharyngitis (48.5%), hyperglycemia (42.4%), diabetes mellitus (24.2%), constipation (18.2%), and hypoglycemia (15.2%).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  11. 11HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, constipation occurred in 18.2%.

    In plain wordsIn Japanese patients receiving pasireotide, 18.2% developed constipation.

    Peptide
    Pasireotide
    Outcome
    Not applicableConstipation
    Study

    n = 33

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with constipation
    18.2%
    most common adverse events

    Source sentences

    Summary
    Almost all patients (97%; 32/33) experienced AEs; the most common AEs were nasopharyngitis (48.5%), hyperglycemia (42.4%), diabetes mellitus (24.2%), constipation (18.2%), and hypoglycemia (15.2%).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  12. 12HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, hypoglycemia occurred in 15.2%.

    In plain wordsIn Japanese patients receiving pasireotide, 15.2% developed low blood glucose.

    Peptide
    Pasireotide
    Outcome
    Not applicableHypoglycemia
    Study

    n = 33

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with hypoglycemia
    15.2%
    most common adverse events

    Source sentences

    Summary
    Almost all patients (97%; 32/33) experienced AEs; the most common AEs were nasopharyngitis (48.5%), hyperglycemia (42.4%), diabetes mellitus (24.2%), constipation (18.2%), and hypoglycemia (15.2%).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  13. 13HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, seven experienced serious adverse events.

    In plain wordsIn Japanese patients receiving pasireotide, seven experienced serious adverse events.

    Peptide
    Pasireotide
    Outcome
    Not applicableSerious adverse events
    Study

    n = 33

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with serious adverse events
    7 patients
    serious adverse events

    Source sentences

    Summary
    Serious AEs were reported in 7 patients with the most common being hyperglycemia (n=2).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  14. 14HumanNon-randomized trialSafety outcome

    In Japanese patients receiving pasireotide, two experienced serious hyperglycemia.

    In plain wordsIn Japanese patients receiving pasireotide, two experienced serious high blood glucose.

    Peptide
    Pasireotide
    Outcome
    Not applicableSerious hyperglycemia
    Study

    n = 33

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Patients with serious hyperglycemia
    2 patients
    most common serious adverse event

    Source sentences

    Summary
    Serious AEs were reported in 7 patients with the most common being hyperglycemia (n=2).
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  15. 15HumanNon-randomized trialEfficacy outcome

    In Japanese patients, pasireotide-associated GH reductions at month 3 persisted to month 12, with a median baseline change of -74.71%.

    In plain wordsIn Japanese patients with acromegaly or pituitary gigantism, the median change in growth hormone from baseline to month 12 was -74.71%.

    Peptide
    Pasireotide
    Outcome
    DecreaseGH levels
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Median percent change in GH from baseline to month 12
    −74.71%
    long-acting pasireotide, pooled dose arms

    Source sentences

    Summary
    Reductions in the median GH and IGF-1 levels observed at month 3 were maintained up to month 12; the median percent change from baseline to month 12 in GH and IGF-1 levels were -74.71% and -59.33%, respectively.
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.
  16. 16HumanNon-randomized trialEfficacy outcome

    In Japanese patients, pasireotide-associated IGF-1 reductions at month 3 persisted to month 12, with a median baseline change of -59.33%.

    In plain wordsIn Japanese patients with acromegaly or pituitary gigantism, the median change in IGF-1 from baseline to month 12 was -59.33%.

    Peptide
    Pasireotide
    Outcome
    DecreaseIGF-1 levels
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    20 mg, 40 mg, or 60 mgAs given in this study (human).

    Measurements

    Median percent change in IGF-1 from baseline to month 12
    −59.33%
    long-acting pasireotide, pooled dose arms

    Source sentences

    Summary
    Reductions in the median GH and IGF-1 levels observed at month 3 were maintained up to month 12; the median percent change from baseline to month 12 in GH and IGF-1 levels were -74.71% and -59.33%, respectively.
    2 context sentences
    Summary · context
    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism.
    Summary · context
    Thirty-three patients (acromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg.

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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

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