Trial reportSurgery today2023
Efficacy, safety, and pharmacokinetics of teduglutide in adult Japanese patients with short bowel syndrome and intestinal failure: two phase III studies with an extension.
Trial report in Surgery today, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 16 citations in OpenAlex.
- Teduglutide in pediatric patients under 10 kg with short bowel syndrome on parenteral support: An open-label study.Pediatrics international : official journal of the Japan Pediatric SocietyTrial
- Successful treatment with teduglutide in short bowel syndrome with intestinal failure secondary to small-bowel volvulus: a case report and literature review.International journal of surgery case reports · 2026Article
- A case report on the long-term use of teduglutide in a pediatric patient with short bowel syndrome.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 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
- Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance.Advances in therapy · 2026Article
- Real-world effectiveness and safety of teduglutide in adult and pediatric patients with short bowel syndrome in Argentina.World journal of gastrointestinal pharmacology and therapeutics · 2025Article
- Safety of Teduglutide for Managing Patients with Short Bowel Syndrome: A Systematic Review and Meta-analysis.Pakistan journal of medical sciences · 2025Review
- Cost-Effectiveness of Teduglutide for Pediatric Patients with Short Bowel Syndrome in Japan, Including Caregiver Burden.Advances in therapy · 2024Article
- Review
- Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
methodsPatients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307). Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
resultsThe parenteral support (PS) volume decreased by ≥ 20% for 9/18 patients at 24 weeks and in all 11 patients by data cut-off in SHP633-307. The mean (standard deviation) PS volume decreased from baseline at 24 weeks in TED-C14-004 (-30.1 ± 25.9%) and SHP633-306 (-25.6 ± 25.5%), and at data cut-off in SHP633-307 (-57.08 ± 28.49%). Teduglutide was absorbed quickly. The adverse events were consistent with the underlying disease and known adverse drug reactions. Anti-teduglutide antibody titers declined with long-term treatment.
conclusionsIn Japanese adults with SBS-IF, teduglutide treatment was associated with clinically meaningful reductions in PS requirements, similar to findings in prior international studies. No new safety concerns specific to the Japanese SBS-IF patient population were identified with short- or long-term teduglutide treatment. Anti-teduglutide antibody titers disappeared in most Japanese adults with long-term treatment. These results constitute the longest evaluation of teduglutide treatment within clinical trials reported to date.
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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.