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Study · Non-randomized trial · n = 43 · 2018

12 results

Safety and efficacy of pasireotide in dumping syndrome-results from a phase 2, multicentre study.

Tack J, Aberle J, Arts J, Laville M, Oppert JM, Bender G, Bhoyrul S, McLaughlin T, Yoshikawa T, Vella A, Zhou J, Passos VQ, O'Connell P, Van Beek AP, Van Beek AP

Alimentary pharmacology & therapeutics25 Apr 2018Cited by 25 (Europe PMC)

PMID29696671 (opens in a new tab)DOI10.1111/apt.14664 (opens in a new tab)PepBankPUB-29696671
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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 study12

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In dumping syndrome patients receiving pasireotide, 26/43 (60.5%, 95% CI 44.4%-75.0%) had no hypoglycaemia during OGTT at month 3.

    In plain wordsIn dumping syndrome patients receiving pasireotide, 26 of 43 had no low blood sugar during testing at month three.

    Peptide
    Pasireotide
    Outcome
    Not applicableAbsence of hypoglycaemia at month 3
    Study

    n = 43

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 3 monthsAs given in this study (human).

    Measurements

    Proportion of patients without hypoglycaemia at month 3
    60.5%
    primary endpoint, single arm
    Patients without hypoglycaemia at month 3
    26 patients
    of 43 enrolled
    95% CI, proportion without hypoglycaemia
    44.4 to 75%
    month 3

    Source sentences

    Summary
    The proportion of patients without hypoglycaemia at month 3 (primary endpoint) was 60.5% (26 of 43; 95% confidence interval, 44.4%-75.0%).
    3 context sentences
    Summary · context
    Primary endpoint was the proportion of patients without hypoglycaemia (plasma glucose <3.3 mmol/L [60 mg/dL] during an oral glucose tolerance test, OGTT) at the end of 3-month SC phase.
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  2. 02HumanNon-randomized trialEfficacy outcome

    In dumping syndrome patients receiving pasireotide, the proportion with an OGTT pulse increase ≥10 beats/min decreased from 60.5% to 18.6% at month 3.

    In plain wordsIn dumping syndrome patients, pulse increases during glucose testing became less frequent than baseline after three months of pasireotide.

    Peptide
    Pasireotide
    Outcome
    DecreasePulse rise during OGTT at month 3
    Study

    n = 43

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    Dose not stated · subcutaneous · 3 monthsAs given in this study (human).

    Measurements

    Patients with pulse rise of 10 beats/min or more during OGTT
    60.5%
    baseline
    Patients with pulse rise of 10 beats/min or more during OGTT
    18.6%
    month 3

    Source sentences

    Summary
    The proportion of patients with a rise in pulse rate of ≥10 beats/min during OGTT reduced from baseline (60.5%) to month 3 (18.6%) and month 12 (27.3%).
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  3. 03HumanNon-randomized trialSafety outcome

    In dumping syndrome patients receiving pasireotide, headache occurred in 34.9% over months 0-12.

    In plain wordsIn dumping syndrome patients receiving pasireotide, 34.9% experienced headache.

    Peptide
    Pasireotide
    Outcome
    Not applicableHeadache
    Study

    n = 43

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated · subcutaneous then intramuscularAs given in this study (human).

    Measurements

    Headache (adverse event)
    34.9 % of patients
    month 0-12, single arm

    Source sentences

    Summary
    Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34.9%)
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  4. 04HumanNon-randomized trialSafety outcome

    In dumping syndrome patients receiving pasireotide, diarrhoea occurred in 27.9% over months 0-12.

    In plain wordsIn dumping syndrome patients receiving pasireotide, 27.9% experienced diarrhoea.

    Peptide
    Pasireotide
    Outcome
    Not applicableDiarrhoea
    Study

    n = 43

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous then intramuscularAs given in this study (human).

    Measurements

    Diarrhoea (adverse event)
    27.9 % of patients
    month 0-12, single arm

    Source sentences

    Summary
    Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34.9%); diarrhoea, hypoglycaemia (27.9% each); fatigue, nausea (23.3% each); and abdominal pain (20.9%).
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  5. 05HumanNon-randomized trialSafety outcome

    In dumping syndrome patients receiving pasireotide, hypoglycaemia occurred in 27.9% over months 0-12.

    In plain wordsIn dumping syndrome patients receiving pasireotide, 27.9% experienced low blood sugar.

    Peptide
    Pasireotide
    Outcome
    Not applicableHypoglycaemia
    Study

    n = 43

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous then intramuscularAs given in this study (human).

    Measurements

    Hypoglycaemia (adverse event)
    27.9 % of patients
    month 0-12, single arm

    Source sentences

    Summary
    Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34.9%); diarrhoea, hypoglycaemia (27.9% each); fatigue, nausea (23.3% each); and abdominal pain (20.9%).
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  6. 06HumanNon-randomized trialSafety outcome

    In dumping syndrome patients receiving pasireotide, fatigue occurred in 23.3% over months 0-12.

    In plain wordsIn dumping syndrome patients receiving pasireotide, 23.3% experienced fatigue.

    Peptide
    Pasireotide
    Outcome
    Not applicableFatigue
    Study

    n = 43

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous then intramuscularAs given in this study (human).

    Measurements

    Fatigue (adverse event)
    23.3 % of patients
    month 0-12, single arm

    Source sentences

    Summary
    Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34.9%); diarrhoea, hypoglycaemia (27.9% each); fatigue, nausea (23.3% each); and abdominal pain (20.9%).
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  7. 07HumanNon-randomized trialSafety outcome

    In dumping syndrome patients receiving pasireotide, nausea occurred in 23.3% over months 0-12.

    In plain wordsIn dumping syndrome patients receiving pasireotide, 23.3% experienced nausea.

    Peptide
    Pasireotide
    Outcome
    Not applicableNausea
    Study

    n = 43

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous then intramuscularAs given in this study (human).

    Measurements

    Nausea (adverse event)
    23.3 % of patients
    month 0-12, single arm

    Source sentences

    Summary
    Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34.9%); diarrhoea, hypoglycaemia (27.9% each); fatigue, nausea (23.3% each); and abdominal pain (20.9%).
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  8. 08HumanNon-randomized trialSafety outcome

    In dumping syndrome patients receiving pasireotide, abdominal pain occurred in 20.9% over months 0-12.

    In plain wordsIn dumping syndrome patients receiving pasireotide, 20.9% experienced abdominal pain.

    Peptide
    Pasireotide
    Outcome
    Not applicableAbdominal pain
    Study

    n = 43

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous then intramuscularAs given in this study (human).

    Measurements

    Abdominal pain (adverse event)
    20.9 % of patients
    month 0-12, single arm

    Source sentences

    Summary
    Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34.9%); diarrhoea, hypoglycaemia (27.9% each); fatigue, nausea (23.3% each); and abdominal pain (20.9%).
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  9. 09HumanNon-randomized trialOther

    In the pasireotide study of late dumping syndrome, 33 of 43 enrolled patients completed the 3-month subcutaneous phase.

    In plain wordsIn the pasireotide study, 33 of 43 patients completed the three-month subcutaneous phase.

    Peptide
    Pasireotide
    Outcome
    Not applicableCompletion of the 3-month subcutaneous phase
    Study

    n = 43

    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    Dose not stated · subcutaneous · 3 monthsAs given in this study (human).

    Measurements

    Patients who completed the 3-month SC phase
    33 patients
    of 43 enrolled

    Source sentences

    Summary
    Forty-three patients with late dumping were enrolled; 33 completed the 3-month SC phase and 23 completed the 12-month study.
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  10. 10HumanNon-randomized trialOther

    In the pasireotide study of late dumping syndrome, 23 of 43 enrolled patients completed the 12-month study.

    In plain wordsIn the pasireotide study, 23 of 43 patients completed the 12-month study.

    Peptide
    Pasireotide
    Outcome
    Not applicableCompletion of the 12-month study
    Study

    n = 43

    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    Dose not stated · subcutaneous then intramuscular · 12-month studyAs given in this study (human).

    Measurements

    Patients who completed the 12-month study
    23 patients
    of 43 enrolled

    Source sentences

    Summary
    Forty-three patients with late dumping were enrolled; 33 completed the 3-month SC phase and 23 completed the 12-month study.
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  11. 11HumanNon-randomized trialEfficacy outcome

    In dumping syndrome patients receiving pasireotide, quality of life improved during the subcutaneous phase and the improvement was maintained in the intramuscular phase.

    In plain wordsIn dumping syndrome patients, quality of life improved during subcutaneous pasireotide treatment and stayed improved during intramuscular treatment.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedQuality of life during subcutaneous and intramuscular phases
    Study

    n: not reported in source

    Outcome group
    Quality of life · Whole body
    Studied dose
    Dose not stated · subcutaneous then intramuscular · 3-month SC phase, then 3-month IM phaseAs given in this study (human).

    Source sentences

    Summary
    Improvement in quality of life was observed during SC phase, which was maintained in the IM phase.
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.
  12. 12HumanNon-randomized trialEfficacy outcome

    In dumping syndrome patients receiving pasireotide, the proportion with an OGTT pulse increase ≥10 beats/min decreased from 60.5% to 27.3% at month 12.

    In plain wordsIn dumping syndrome patients, pulse increases during glucose testing were less frequent at month twelve than baseline during pasireotide treatment.

    Peptide
    Pasireotide
    Outcome
    DecreasePulse rise during OGTT at month 12
    Study

    n: not reported in source

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    Dose not stated

    Measurements

    Patients with pulse rise of 10 beats/min or more during OGTT
    60.5%
    baseline
    Patients with pulse rise of 10 beats/min or more during OGTT
    27.3%
    month 12

    Source sentences

    Summary
    The proportion of patients with a rise in pulse rate of ≥10 beats/min during OGTT reduced from baseline (60.5%) to month 3 (18.6%) and month 12 (27.3%).
    2 context sentences
    Summary · context
    To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.
    Summary · context
    A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase.

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

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