Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure.

O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association17 Jan 2013Cited by 122 (Europe PMC)

PMID23333663DOI10.1016/j.cgh.2012.12.029PepBankPUB-23333663

Publisher page PubMedAsk about this study

Jump to 11 results

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 study11

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

01HumanNon-randomized trialSafety outcome
In patients with short bowel intestinal failure receiving teduglutide, 35% reported headache.
In plain wordsIn patients with short bowel intestinal failure receiving teduglutide, 35% reported headache.
Peptide
Teduglutide
Outcome
Not applicableHeadache
Study
n = 52
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.05 or 0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients reporting headache
35%
headache, all teduglutide patients
Source sentences
Summary
The most common adverse events reported included headache (35%), nausea (31%), and abdominal pain (25%); 7 patients withdrew because of adverse events (gastrointestinal disorders in 4).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366301
02HumanNon-randomized trialSafety outcome
In patients with short bowel intestinal failure receiving teduglutide, 31% reported nausea.
In plain wordsIn patients with short bowel intestinal failure receiving teduglutide, 31% reported nausea.
Peptide
Teduglutide
Outcome
Not applicableNausea
Study
n = 52
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.05 or 0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients reporting nausea
31%
nausea, all teduglutide patients
Source sentences
Summary
The most common adverse events reported included headache (35%), nausea (31%), and abdominal pain (25%); 7 patients withdrew because of adverse events (gastrointestinal disorders in 4).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366302
03HumanNon-randomized trialSafety outcome
In patients with short bowel intestinal failure receiving teduglutide, 25% reported abdominal pain.
In plain wordsIn patients with short bowel intestinal failure receiving teduglutide, 25% reported abdominal pain.
Peptide
Teduglutide
Outcome
Not applicableAbdominal pain
Study
n = 52
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.05 or 0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients reporting abdominal pain
25%
abdominal pain, all teduglutide patients
Source sentences
Summary
The most common adverse events reported included headache (35%), nausea (31%), and abdominal pain (25%); 7 patients withdrew because of adverse events (gastrointestinal disorders in 4).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366303
04HumanNon-randomized trialSafety outcome
In patients with short bowel intestinal failure receiving teduglutide, 7 withdrew because of adverse events.
In plain wordsIn patients with short bowel intestinal failure receiving teduglutide, 7 withdrew because of adverse events.
Peptide
Teduglutide
Outcome
Not applicableWithdrawal due to adverse events
Study
n = 52
Outcome group
Adverse events · Whole body
Studied dose
0.05 or 0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients withdrawn because of adverse events
7 patients
all teduglutide patients
Source sentences
Summary
The most common adverse events reported included headache (35%), nausea (31%), and abdominal pain (25%); 7 patients withdrew because of adverse events (gastrointestinal disorders in 4).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366304
05HumanNon-randomized trialSafety outcome
In patients with short bowel intestinal failure receiving teduglutide, 4 withdrew because of gastrointestinal disorders.
In plain wordsIn patients with short bowel intestinal failure receiving teduglutide, 4 withdrew because of gastrointestinal disorders.
Peptide
Teduglutide
Outcome
Not applicableWithdrawal due to gastrointestinal disorders
Study
n = 52
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.05 or 0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients withdrawn because of gastrointestinal disorders
4 patients
subset of the 7 withdrawals due to adverse events
Source sentences
Summary
The most common adverse events reported included headache (35%), nausea (31%), and abdominal pain (25%); 7 patients withdrew because of adverse events (gastrointestinal disorders in 4).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366305
06HumanNon-randomized trialEfficacy outcome
In patients with short bowel intestinal failure receiving teduglutide, four achieved complete independence from parenteral nutrition.
In plain wordsIn patients with short bowel intestinal failure receiving teduglutide, four achieved complete independence from parenteral nutrition.
Peptide
Teduglutide
Outcome
Not applicableComplete independence from PN
Study
n = 52
Outcome group
Parenteral support · Gastrointestinal
Studied dose
0.05 or 0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients achieving complete independence from PN
4 patients
52 patients given teduglutide for 52 weeks
Source sentences
Summary
Four patients achieved complete independence from PN.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366311
07HumanNon-randomized trialEfficacy outcome
In patients with short bowel intestinal failure, both teduglutide dose groups had progressive reductions in parenteral nutrition.
In plain wordsIn patients with short bowel intestinal failure, both teduglutide dose groups had progressive reductions in parenteral nutrition.
Peptide
Teduglutide
Outcome
DecreaseProgressive PN reduction
Study
n: not reported in source
Outcome group
Parenteral support · Gastrointestinal
Studied dose
0.05 or 0.10 mg/kg/d · 52 weeksAs given in this study (human).
Source sentences
Summary
Both groups had progressive reduction in PN.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366306
08HumanNon-randomized trialEfficacy outcome
In patients with short bowel intestinal failure, 68% receiving teduglutide 0.05 mg/kg/d had a ≥20% reduction in weekly PN volume at week 52.
In plain wordsIn patients with short bowel intestinal failure, 68% on lower-dose teduglutide achieved at least a 20% reduction in PN volume from baseline.
Peptide
Teduglutide
Outcome
Not applicablePN volume responder proportion at lower dose
Study
n: not reported in source
Outcome group
Parenteral support · Gastrointestinal
Studied dose
0.05 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients with ≥20% reduction in weekly PN volume at week 52
68%
teduglutide 0.05 mg/kg/d
Source sentences
Summary
At week 52, 68% of the 0.05-mg/kg/d and 52% of the 0.10-mg/kg/d dose group had a ≥20% reduction in PN, with a reduction of 1 or more days of PN dependency in 68% and 37%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Report a problemFND-2333366307
09HumanNon-randomized trialEfficacy outcome
In patients with short bowel intestinal failure, 52% receiving teduglutide 0.10 mg/kg/d had a ≥20% reduction in weekly PN volume at week 52.
In plain wordsIn patients with short bowel intestinal failure, 52% on higher-dose teduglutide achieved at least a 20% reduction in PN volume from baseline.
Peptide
Teduglutide
Outcome
Not applicablePN volume responder proportion at higher dose
Study
n: not reported in source
Outcome group
Parenteral support · Gastrointestinal
Studied dose
0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients with ≥20% reduction in weekly PN volume at week 52
52%
teduglutide 0.10 mg/kg/d
Source sentences
Summary
At week 52, 68% of the 0.05-mg/kg/d and 52% of the 0.10-mg/kg/d dose group had a ≥20% reduction in PN, with a reduction of 1 or more days of PN dependency in 68% and 37%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Report a problemFND-2333366308
10HumanNon-randomized trialEfficacy outcome
In patients with short bowel intestinal failure, 68% receiving teduglutide 0.05 mg/kg/d reduced PN dependency by 1 or more days at week 52.
In plain wordsIn patients with short bowel intestinal failure, 68% on lower-dose teduglutide reduced PN dependency by at least one day.
Peptide
Teduglutide
Outcome
Not applicablePN dependency day reduction at lower dose
Study
n: not reported in source
Outcome group
Parenteral support · Gastrointestinal
Studied dose
0.05 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients with reduction of 1 or more days of PN dependency at week 52
68%
teduglutide 0.05 mg/kg/d
Source sentences
Summary
At week 52, 68% of the 0.05-mg/kg/d and 52% of the 0.10-mg/kg/d dose group had a ≥20% reduction in PN, with a reduction of 1 or more days of PN dependency in 68% and 37%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366309
11HumanNon-randomized trialEfficacy outcome
In patients with short bowel intestinal failure, 37% receiving teduglutide 0.10 mg/kg/d reduced PN dependency by 1 or more days at week 52.
In plain wordsIn patients with short bowel intestinal failure, 37% on higher-dose teduglutide reduced PN dependency by at least one day.
Peptide
Teduglutide
Outcome
Not applicablePN dependency day reduction at higher dose
Study
n: not reported in source
Outcome group
Parenteral support · Gastrointestinal
Studied dose
0.10 mg/kg/d · 52 weeksAs given in this study (human).
Measurements
Patients with reduction of 1 or more days of PN dependency at week 52
37%
teduglutide 0.10 mg/kg/d
Source sentences
Summary
At week 52, 68% of the 0.05-mg/kg/d and 52% of the 0.10-mg/kg/d dose group had a ≥20% reduction in PN, with a reduction of 1 or more days of PN dependency in 68% and 37%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide.
Summary · context
We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
Report a problemFND-2333366310

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 postedNCT00172185

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Shiren = 6510 Jan 2005 to 24 Jan 2008

Short Bowel Syndrome

Trial page ClinicalTrials.govUpdated 2 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.

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

MeSH terms

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