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Study · Non-randomized trial · 2020

9 results

Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials.

Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J

Therapeutic advances in gastroenterology20 Apr 2020Cited by 42 (Europe PMC)

PMID32341691 (opens in a new tab)PMCIDPMC7171995 (opens in a new tab)DOI10.1177/1756284820905766 (opens in a new tab)PepBankPUB-32341691
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In adults with SBS-IF receiving teduglutide, adverse events were mostly mild or moderate, as in other patient groups.

    In plain wordsIn adults with SBS-IF receiving teduglutide, adverse events were mostly mild or moderate, as in other groups.

    Peptide
    Teduglutide
    Outcome
    Direction not reportedAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In most patients, AEs were reported as mild or moderate in severity in all patient groups and occurred at comparable rates between patients who received teduglutide or placebo.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  2. 02HumanNon-randomized trialSafety outcome

    In adults with SBS-IF, adverse event rates were comparable between teduglutide and placebo.

    In plain wordsIn adults with SBS-IF, adverse event rates were similar with teduglutide and placebo.

    Peptide
    Teduglutide
    Outcome
    Direction not reportedAdverse event rates
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In most patients, AEs were reported as mild or moderate in severity in all patient groups and occurred at comparable rates between patients who received teduglutide or placebo.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  3. 03HumanNon-randomized trialSafety outcome

    In adults with SBS-IF receiving teduglutide, abdominal pain was more frequent early and declined over time.

    In plain wordsIn adults with SBS-IF receiving teduglutide, abdominal pain became less frequent over treatment time.

    Peptide
    Teduglutide
    Outcome
    DecreaseAbdominal pain over time
    Study

    n: not reported in source

    Comparator
    Earlier treatment
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Several common gastrointestinal AEs, including abdominal pain, nausea and abdominal distension, were reported more frequently earlier in the course of treatment, with their frequency declining over time.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with SBS-IF receiving teduglutide, nausea was more frequent early and declined over time.

    In plain wordsIn adults with SBS-IF receiving teduglutide, nausea became less frequent over treatment time.

    Peptide
    Teduglutide
    Outcome
    DecreaseNausea over time
    Study

    n: not reported in source

    Comparator
    Earlier treatment
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Several common gastrointestinal AEs, including abdominal pain, nausea and abdominal distension, were reported more frequently earlier in the course of treatment, with their frequency declining over time.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  5. 05HumanNon-randomized trialSafety outcome

    In adults with SBS-IF receiving teduglutide, abdominal distension was more frequent early and declined over time.

    In plain wordsIn adults with SBS-IF receiving teduglutide, abdominal swelling became less frequent over treatment time.

    Peptide
    Teduglutide
    Outcome
    DecreaseAbdominal distension over time
    Study

    n: not reported in source

    Comparator
    Earlier treatment
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Several common gastrointestinal AEs, including abdominal pain, nausea and abdominal distension, were reported more frequently earlier in the course of treatment, with their frequency declining over time.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  6. 06HumanObservational studySafety outcome

    In pooled data from four teduglutide trials in adults with SBS-IF, fewer gastrointestinal adverse events were reported in patients with vascular causes than in other subgroups.

    In plain wordsIn pooled teduglutide trial data from adults with SBS-IF, patients with vascular causes had fewer gut adverse events than other subgroups.

    Peptide
    Teduglutide
    Outcome
    DecreaseGastrointestinal adverse events by etiology
    Study

    n: not reported in source

    Comparator
    Other patient subgroups
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Fewer gastrointestinal AEs were reported in patients with vascular causes of SBS-IF and patients with most of their colon-in-continuity than in other patient subgroups.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  7. 07HumanObservational studySafety outcome

    In pooled data from four teduglutide trials in adults with SBS-IF, fewer gastrointestinal adverse events were reported in patients with most of their colon in continuity than in other subgroups.

    In plain wordsIn pooled teduglutide trial data from adults with SBS-IF, patients with most of the colon in continuity had fewer gut adverse events than other subgroups.

    Peptide
    Teduglutide
    Outcome
    DecreaseGastrointestinal adverse events by colon continuity
    Study

    n: not reported in source

    Comparator
    Other patient subgroups
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Fewer gastrointestinal AEs were reported in patients with vascular causes of SBS-IF and patients with most of their colon-in-continuity than in other patient subgroups.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  8. 08HumanObservational studySafety outcome

    Across adult SBS-IF subgroups, teduglutide significantly increased relative risk of abdominal distension versus placebo.

    In plain wordsIn adults with SBS-IF, teduglutide increased abdominal swelling risk versus placebo.

    Peptide
    Teduglutide
    Outcome
    IncreaseAbdominal distension risk
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Across the patient stratification subgroups, the predominant treatment-emergent AEs for which patients receiving teduglutide had a significantly increased relative risk were abdominal distension and gastrointestinal stoma complication compared with patients receiving placebo.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.
  9. 09HumanObservational studySafety outcome

    Across adult SBS-IF subgroups, teduglutide significantly increased relative risk of gastrointestinal stoma complications versus placebo.

    In plain wordsIn adults with SBS-IF, teduglutide increased gut stoma complication risk versus placebo.

    Peptide
    Teduglutide
    Outcome
    IncreaseGastrointestinal stoma complication risk
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Across the patient stratification subgroups, the predominant treatment-emergent AEs for which patients receiving teduglutide had a significantly increased relative risk were abdominal distension and gastrointestinal stoma complication compared with patients receiving placebo.
    2 context sentences
    Summary · context
    Safety data from four prospective clinical trials of teduglutide in patients with SBS-IF were assimilated.
    Summary · context
    AEs were evaluated in patient groups based on treatment received in each study and in populations stratified to create distinct subgroups based on aetiology, bowel anatomy and baseline PS volume requirements.

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 postedNCT00930644

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Shiren = 8821 Sept 2009 to 24 Jan 2013

Short Bowel Syndrome

Trial pageClinicalTrials.govUpdated 11 Jun 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, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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