ArticleJPEN. Journal of parenteral and enteral nutrition2021
Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure: Pooled Analysis of 4 Clinical Studies.
Article in JPEN. Journal of parenteral and enteral nutrition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects Aged 1 Year Through 17 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support
A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age With Short Bowel Syndrome Who Are Dependent on Parenteral Support
A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed TED-C13-003
A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301
Who cites it
13 citing papers in PubMed, 33 citations in OpenAlex.
- Malnutrition enteropathy in Zambian and Zimbabwean children with severe acute malnutrition: A multi-arm randomized phase II trial.Nature communications · 2024Trial
- Efficacy and safety of teduglutide in children with short bowel syndrome: a narrative review.Pediatric surgery international · 2026Review
- [Use of teduglutide in short bowel syndrome in infants, children and adolescents: Position paper of the working group "Chronic intestinal failure" of the Society for Paediatric Gastroenterology and Nutrition (GPGE)].Zeitschrift fur Gastroenterologie · 2026Article
- Effectiveness and Safety of Teduglutide Treatment in Adult Patients with Short Bowel Syndrome: A Case Series and Review of Current Evidence.Journal of clinical medicine · 2026Article
- Drug-induced intestinal obstruction: insights from the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2026Article
- Three-year experience with GLP-2 analog in intestinal rehabilitation for pediatric-onset short bowel syndrome.Pediatric surgery international · 2025Article
- Predictors of response and enteral autonomy in children with short bowel syndrome treated with teduglutide: a real-life multicentre cohort study.EClinicalMedicine · 2025Article
- Observational
- The Development of the International Intestinal Failure Registry and an Overview of its Results.European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie · 2024Review
- The real-world analysis of adverse events with teduglutide: a pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2024Article
- Gastric Foveolar Hyperplastic Polyps in 2 Children With Short Bowel Syndrome on Long-Term Teduglutide.JPGN reports · 2023Article
- Real-world efficacy of long-term teduglutide use in pediatric patients with short bowel syndrome.Intestinal Failure (New York, N.Y.)Article
- Clinical outcomes of teduglutide therapy in children with short bowel syndrome-associated intestinal failure: A single-center experience.Intestinal Failure (New York, N.Y.)Article
Corrections and comments
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Authors and funding
17 authors at 14 institutions in 4 countries.
Funding
Abstract
backgroundThis analysis assessed combined safety data from 4 clinical studies of teduglutide in pediatric patients with short-bowel syndrome-associated intestinal failure (SBS-IF).
methodsSafety data from teduglutide-treated patients in 4 clinical trials were pooled. The completed 12-week and 24-week phase 3 core studies (NCT01952080/EudraCT 2013-004588-30 and NCT02682381/EudraCT 2015-002252-27) enrolled children aged 1-17 years with SBS-IF. Patients could elect to enroll in ongoing open-label extensions (NCT02949362/EudraCT 2016-000863-17 and NCT02954458/EudraCT 2016-000849-30). Interim data from ongoing studies were included.
resultsSafety data are reported for 89 pediatric patients treated with teduglutide for a median (range) of 51.7 (5.0-94.7) weeks. Adverse events (AEs) were reported in all patients; the most common were vomiting (51.7%), pyrexia (43.8%), upper respiratory tract infection (41.6%), and cough (33.7%). Thirty-five patients (39.3%) had AEs considered related to teduglutide treatment; abdominal pain and vomiting were most frequent (5.6% each). Three serious AEs in 3 patients (3.4%) were considered related to teduglutide treatment: ileus, d-lactic acidosis, and gastrointestinal obstruction due to hard stools. All 3 events resolved. One cecal polyp was detected, which was not biopsied or found on repeat colonoscopy. No cases of neoplasia occurred.
conclusionBased on integrated data from 4 clinical studies, including long-term follow-up for ≤161 weeks, teduglutide had a safety profile consistent with the individual core pediatric studies and as expected for pediatric patients with SBS-IF who never received teduglutide. The most frequent AEs reflected treatment with teduglutide, complications of the underlying disease, and typical childhood illnesses.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.