Long-Term Teduglutide for the Treatment of Patients With Intestinal Failure Associated With Short Bowel Syndrome.

Schwartz LK, O'Keefe SJ, Fujioka K, Gabe SM, Lamprecht G, Pape UF, Li B, Youssef NN, Jeppesen PB

Clinical and translational gastroenterology4 Feb 2016Cited by 157 (Europe PMC)

PMID26844839PMCIDPMC4817413DOI10.1038/ctg.2015.69PepBankPUB-26844839

Read at source PubMedAsk about this study

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-ND. Results still quote short attributed sentences.

Results from this study11

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

01HumanNon-randomized trialSafety outcome
In patients with short bowel syndrome, 34% reported abdominal pain during the teduglutide extension study.
In plain wordsIn patients with short bowel syndrome, 34% reported abdominal pain during the teduglutide extension study.
Peptide
Teduglutide
Outcome
Not applicableAbdominal pain
Study
n = 88
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED)As given in this study (human).
Measurements
Patients with abdominal pain
34%
treatment-emergent adverse event, STEPS-2 extension
Source sentences
Summary
The most common treatment-emergent adverse events were abdominal pain (34%), catheter sepsis (28%), and decreased weight (25%).
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483901
02HumanNon-randomized trialSafety outcome
In patients with short bowel syndrome, 28% reported catheter sepsis during the teduglutide extension study.
In plain wordsIn patients with short bowel syndrome, 28% reported catheter sepsis during the teduglutide extension study.
Peptide
Teduglutide
Outcome
Not applicableCatheter sepsis
Study
n = 88
Outcome group
Adverse events · Infection
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED)As given in this study (human).
Measurements
Patients with catheter sepsis
28%
treatment-emergent adverse event, STEPS-2 extension
Source sentences
Summary
The most common treatment-emergent adverse events were abdominal pain (34%), catheter sepsis (28%), and decreased weight (25%).
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483902
03HumanNon-randomized trialSafety outcome
In patients with short bowel syndrome, 25% reported decreased weight during the teduglutide extension study.
In plain wordsIn patients with short bowel syndrome, 25% reported decreased weight during the teduglutide extension study.
Peptide
Teduglutide
Outcome
Not applicableDecreased weight adverse event
Study
n = 88
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED)As given in this study (human).
Measurements
Patients with decreased weight
25%
treatment-emergent adverse event, STEPS-2 extension
Source sentences
Summary
The most common treatment-emergent adverse events were abdominal pain (34%), catheter sepsis (28%), and decreased weight (25%).
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483903
04HumanNon-randomized trialEfficacy outcome
Among TED/TED completers with short bowel syndrome, 28/30 (93%) achieved a 20-100% reduction in weekly parenteral support from baseline.
In plain wordsAmong TED/TED completers with short bowel syndrome, 93% achieved the defined reduction in parenteral support from baseline.
Peptide
Teduglutide
Outcome
Not applicableClinical response in TED/TED completers
Study
n = 30
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 30 monthsAs given in this study (human).
Measurements
Clinical response rate, TED/TED completers
28 patients
of 30 completers
Clinical response rate, TED/TED completers
93%
28/30 completers
Source sentences
Summary
In patients who completed the study, clinical response was achieved in 28/30 (93%) TED/TED, 16/29 (55%) PBO/TED, and 4/6 (67%) NT/TED patients.
4 context sentences(design, population, supporting numbers)
Summary · context
Clinical response was defined as 20-100% reduction from baseline in weekly PS volume; baseline was considered the beginning of teduglutide treatment in the initial placebo-controlled study (TED/TED) or STEPS-2 (NT/TED and PBO/TED).
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483905
05HumanNon-randomized trialEfficacy outcome
Among PBO/TED completers with short bowel syndrome, 16/29 (55%) achieved a 20-100% reduction in weekly parenteral support from baseline.
In plain wordsAmong PBO/TED completers with short bowel syndrome, 55% achieved the defined reduction in parenteral support from baseline.
Peptide
Teduglutide
Outcome
Not applicableClinical response in PBO/TED completers
Study
n = 29
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 monthsAs given in this study (human).
Measurements
Clinical response rate, PBO/TED completers
16 patients
of 29 completers
Clinical response rate, PBO/TED completers
55%
16/29 completers
Source sentences
Summary
In patients who completed the study, clinical response was achieved in 28/30 (93%) TED/TED, 16/29 (55%) PBO/TED, and 4/6 (67%) NT/TED patients.
4 context sentences(design, population, supporting numbers)
Summary · context
Clinical response was defined as 20-100% reduction from baseline in weekly PS volume; baseline was considered the beginning of teduglutide treatment in the initial placebo-controlled study (TED/TED) or STEPS-2 (NT/TED and PBO/TED).
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483906
06HumanNon-randomized trialEfficacy outcome
Among NT/TED completers with short bowel syndrome, 4/6 (67%) achieved a 20-100% reduction in weekly parenteral support from baseline.
In plain wordsAmong NT/TED completers with short bowel syndrome, 67% achieved the defined reduction in parenteral support from baseline.
Peptide
Teduglutide
Outcome
Not applicableClinical response in NT/TED completers
Study
n = 6
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 monthsAs given in this study (human).
Measurements
Clinical response rate, NT/TED completers
4 patients
of 6 completers
Clinical response rate, NT/TED completers
67%
4/6 completers
Source sentences
Summary
In patients who completed the study, clinical response was achieved in 28/30 (93%) TED/TED, 16/29 (55%) PBO/TED, and 4/6 (67%) NT/TED patients.
4 context sentences(design, population, supporting numbers)
Summary · context
Clinical response was defined as 20-100% reduction from baseline in weekly PS volume; baseline was considered the beginning of teduglutide treatment in the initial placebo-controlled study (TED/TED) or STEPS-2 (NT/TED and PBO/TED).
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483907
07HumanNon-randomized trialEfficacy outcome
In patients with short bowel syndrome, mean weight, body mass index and serum albumin remained stable during teduglutide treatment.
In plain wordsIn patients with short bowel syndrome, weight, body mass index and serum albumin remained stable during teduglutide treatment.
Peptide
Teduglutide
Outcome
No significant changeWeight, body mass index and serum albumin stability
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED)As given in this study (human).
Source sentences
Summary
Mean weight, body mass index, and serum albumin remained stable.
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483904
08HumanNon-randomized trialEfficacy outcome
In TED/TED patients with short bowel syndrome, mean parenteral support volume fell by 7.6 l/week (66%) from baseline.
In plain wordsIn TED/TED patients with short bowel syndrome, mean parenteral support volume fell by 66% from baseline.
Peptide
Teduglutide
Outcome
DecreasePS volume reduction in TED/TED
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 30 monthsAs given in this study (human).
Measurements
Mean PS volume reduction from baseline
7.6 l/week
TED/TED group
Mean PS volume reduction from baseline
66%
TED/TED group
Source sentences
Summary
Mean PS volume reductions from baseline were 7.6 (66%), 3.1 (28%), and 4.0 (39%) l/week in the TED/TED, PBO/TED, and NT/TED groups, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483908
09HumanNon-randomized trialEfficacy outcome
In PBO/TED patients with short bowel syndrome, mean parenteral support volume fell by 3.1 l/week (28%) from baseline.
In plain wordsIn PBO/TED patients with short bowel syndrome, mean parenteral support volume fell by 28% from baseline.
Peptide
Teduglutide
Outcome
DecreasePS volume reduction in PBO/TED
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 monthsAs given in this study (human).
Measurements
Mean PS volume reduction from baseline
3.1 l/week
PBO/TED group
Mean PS volume reduction from baseline
28%
PBO/TED group
Source sentences
Summary
Mean PS volume reductions from baseline were 7.6 (66%), 3.1 (28%), and 4.0 (39%) l/week in the TED/TED, PBO/TED, and NT/TED groups, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483909
10HumanNon-randomized trialEfficacy outcome
In NT/TED patients with short bowel syndrome, mean parenteral support volume fell by 4.0 l/week (39%) from baseline.
In plain wordsIn NT/TED patients with short bowel syndrome, mean parenteral support volume fell by 39% from baseline.
Peptide
Teduglutide
Outcome
DecreasePS volume reduction in NT/TED
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 monthsAs given in this study (human).
Measurements
Mean PS volume reduction from baseline
4 l/week
NT/TED group
Mean PS volume reduction from baseline
39%
NT/TED group
Source sentences
Summary
Mean PS volume reductions from baseline were 7.6 (66%), 3.1 (28%), and 4.0 (39%) l/week in the TED/TED, PBO/TED, and NT/TED groups, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483910
11HumanNon-randomized trialEfficacy outcome
In the teduglutide extension study of short bowel syndrome, thirteen patients achieved full enteral autonomy.
In plain wordsIn the teduglutide extension study of short bowel syndrome, thirteen patients achieved full enteral autonomy.
Peptide
Teduglutide
Outcome
Not applicableFull enteral autonomy
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · subcutaneous · up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED)As given in this study (human).
Measurements
Patients achieving full enteral autonomy
13 patients
STEPS-2 extension
Source sentences
Summary
Thirteen patients achieved full enteral autonomy.
3 context sentences(design, population, supporting numbers)
Summary · context
STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
Summary · context
Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment.
Summary · context
Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED).
Report a problemFND-2684483911

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

PepBank is a research reference. Talk to a doctor before you use any peptide.