Evidence map›Paper›PMID 31495952›Full record

ArticleJPEN. Journal of parenteral and enteral nutrition2020

Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study.

Samuel A Kocoshis, Russell J Merritt, Susan Hill, Susan Protheroe, Beth A Carter, Simon Horslen, Simin Hu, Stuart S Kaufman, David F Mercer, Mikko P Pakarinen and 3 more

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JPEN. Journal of parenteral and enteral nutrition, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04832087 (Pediatric Teduglutide Registry), which is not on this map. Cited by 55 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 pooled it
8.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04832087 completednot on this mapstarted 2021, after this paper: background citation

Pediatric Teduglutide Registry: Clinical Use of Teduglutide in Children With Intestinal Failure, a Multicenter Post-marketing Evaluation

Typeobservational_patient_registrySponsorBoston Children's HospitalRan2021 to 2023Enrolled142ConditionsShort Bowel SyndromeArmsTeduglutide
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 1 synthesis or guideline pooled it, 144 citations in OpenAlex.

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  7. 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 · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 13 institutions in 4 countries.

Samuel A KocoshisCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Russell J MerrittChildren's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Susan HillGreat Ormond Street Hospital for Children NHS Foundation Trust, London, UK.
Susan ProtheroeBirmingham Children's Hospital NHS Foundation Trust, Birmingham, UK.
Beth A CarterTexas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.
Simon HorslenSeattle Children's Hospital and University of Washington School of Medicine, Seattle, Washington, USA.
Simin HuShire Human Genetic Therapies, Inc, Lexington, Massachusetts, USA.
Stuart S KaufmanMedStar Georgetown University Hospital, Washington, District of Columbia, USA.
David F MercerUniversity of Nebraska Medical Center, Omaha, Nebraska, USA.
Mikko P PakarinenChildren's Hospital, Pediatric Research Center, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.
Robert S VenickMattel Children's Hospital UCLA, Department of Pediatrics, Los Angeles, California, USA.
Paul W WalesThe Hospital for Sick Children, Toronto, Ontario, Canada.
Andrew A GrimmShire Human Genetic Therapies, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0001-9915-8403
Baylor College of Medicine · USBirmingham Children's Hospital · GBCincinnati Children's Hospital Medical Center · USGeorgetown University · USGreat Ormond Street Hospital for Children NHS Foundation Trust · GBHospital for Sick Children · CAMattel Children's Hospital · USResearch Institute for Genetic and Human Therapy · USSeattle Children's Hospital · USTakeda (United States) · USUniversity of Helsinki · FIUniversity of Nebraska Medical Center · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the safety and efficacy of teduglutide in pediatric patients with short bowel syndrome-associated intestinal failure (SBS-IF).

methodsA 24-week, phase III trial with 2 randomized, double-blind teduglutide dose groups and a nonblinded standard of care (SOC) arm was used; patients received 0.025 mg/kg or 0.05 mg/kg teduglutide once daily. Safety end points included treatment-emergent adverse events (TEAEs) and growth parameters. The primary efficacy/pharmacodynamic end point was the number of patients who achieved a ≥20% reduction in parenteral support (PS) from baseline at week 24.

resultsAll 59 enrolled patients completed the study (0.025 mg/kg, n = 24; 0.05 mg/kg, n = 26; SOC, n = 9). Baseline demographics and disease characteristics were comparable among groups. TEAEs were reported by 98% and 100% of patients in the teduglutide and SOC groups, respectively. The most common TEAEs in the teduglutide-treated groups were pyrexia and vomiting. The primary end point was achieved by 13 (54.2%), 18 (69.2%), and 1 (11.1%) patients who received 0.025 mg/kg teduglutide, 0.05 mg/kg teduglutide, and SOC, respectively (P < 0.05 vs SOC). Both 0.025-mg/kg and 0.05-mg/kg teduglutide groups showed clinically significant reductions in PS volume (P < 0.05 vs SOC), PS calories, days per week and hours per day of PS infusions, and increases in enteral nutrition and plasma citrulline at week 24 compared with baseline. Two (8.3%, 0.025 mg/kg teduglutide) and 3 patients (11.5%, 0.05 mg/kg teduglutide) achieved enteral autonomy.

conclusionThe safety profile of teduglutide was similar to that reported previously in children and adults. Treatment with teduglutide was associated with significant reductions in PS for pediatric patients with SBS-IF over 24 weeks.

Indexed as

Short Bowel SyndromeAdultAgedChildChild, PreschoolDouble-Blind MethodFemaleGastrointestinal AgentsHumansMaleParenteral NutritionPeptidesGastrointestinal AgentsPeptidesteduglutidegastroenterologyparenteral nutritionpediatricsshort bowel syndrome

Identifiers

PMID31495952
PMCPMC7318247
OpenAlexW2972553335

What OpenQuestion holds

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LicenceCC BY-NC
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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.