Evidence map›Paper›PMID 27875291›Full record

Trial reportJPEN. Journal of parenteral and enteral nutrition2017

Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome.

Kishore R Iyer, Marek Kunecki, Joseph I Boullata, Ken Fujioka, Francisca Joly, Simon Gabe, Ulrich-Frank Pape, Stéphane M Schneider, María Nuria Virgili Casas, Thomas R Ziegler and 3 more

5 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JPEN. Journal of parenteral and enteral nutrition, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 3% 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.

NCT00081458 phase3completednot on this map

A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

TypeinterventionalSponsorShireRan2004 to 2007Enrolled84ConditionsShort Bowel SyndromeArmsPlacebo, Teduglutide 0.05 mg/kg/d, Teduglutide 0.1 mg/kg/d
NCT00172185 phase3completednot on this map

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

TypeinterventionalSponsorShireRan2005 to 2008Enrolled65ConditionsShort Bowel SyndromeArmsteduglutide 0.05 mg/kg/d, teduglutide 0.10 mg/kg/d
NCT00798967 phase3completednot on this map

A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

TypeinterventionalSponsorShireRan2008 to 2011Enrolled86ConditionsShort Bowel SyndromeArmsteduglutide, placebo
NCT00930644 phase3completednot on this map

A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

TypeinterventionalSponsorShireRan2009 to 2013Enrolled88ConditionsShort Bowel SyndromeArmsteduglutide
NCT01560403 phase3completednot on this map

A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

TypeinterventionalSponsorShireRan2012 to 2013Enrolled14ConditionsShort Bowel SyndromeArmsTeduglutide
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
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  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Teduglutide in short bowel syndrome patients: A way back to normal life?JPEN. Journal of parenteral and enteral nutrition · 2022
    Article
  17. Review
  18. Proglucagon-Derived Peptides as Therapeutics.Frontiers in endocrinology · 2021
    Review
  19. Article
  20. Review
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 12 institutions in 6 countries.

Kishore R Iyer1 Adult and Pediatric Intestinal Transplant & Rehabilitation Program, Mount Sinai Medical Center, New York, New York, USA.
Marek Kunecki2 Department of Clinical Nutrition, M. Pirogow Hospital, Lódz, Poland.
Joseph I Boullata3 Department of Biobehavioral and Health Sciences, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Ken Fujioka4 Department of Endocrinology, Scripps Clinic, La Jolla, California, USA.
Francisca Joly5 Gastroenterology, IBD, and Nutrition Support, Beaujon Hospital, Clichy, France, and Gastrointestinal and Metabolic Dysfunctions in Nutritional Pathologies, Inserm UMR 1149, Centre de Recherche sur l'Inflammation Paris Montmartre UFR de Médecine Paris Diderot, Paris, France.
Simon Gabe6 Lennard Jones Intestinal Failure Unit, St Mark's Hospital, Northwick Park, London, United Kingdom.
Ulrich-Frank Pape7 Department of Hepatology & Gastroenterology, Charité University Medicine, Berlin, Germany.
Stéphane M Schneider8 Gastroentérologie et Nutrition Clinique, Université de Nice Sophia-Antipolis, Nice, France.
María Nuria Virgili Casas9 Unit of Nutrition and Dietetics, Department of Endocrinology and Nutrition, Bellvitge University Hospital, Barcelona, Spain.
Thomas R Ziegler10 Department of Medicine, Division of Endocrinology, Metabolism and Lipids and Center for Clinical and Molecular Nutrition, Emory University School of Medicine, Atlanta, Georgia, USA.
Benjamin Li11 Department of Statistics, NPS Pharmaceuticals, Inc, Lexington, Massachusetts, USA.
Nader N Youssef12 Clinical Research and Development, NPS Pharmaceuticals, Inc, Lexington, Massachusetts, USA.
Palle B Jeppesen13 Department of Medical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
Amicus Therapeutics (United States) · USBellvitge University Hospital · ESCentre de Recherche sur l'Inflammation · FRCharité - Universitätsmedizin Berlin · DEDigestive Care (United States) · USEmory University · USMount Sinai Medical Center · USRigshospitalet · DKScripps Clinic · USSt Mark's Hospital · GBUniversité Côte d'Azur · FRUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn phase III clinical studies, treatment with teduglutide was associated with clinically meaningful reductions (≥20% from baseline) in parenteral support (PS; parenteral nutrition and/or intravenous fluids) requirements in adult patients with intestinal failure associated with short bowel syndrome (SBS-IF). This analysis reports clinical characteristics of patients who achieved complete independence from PS during teduglutide treatment. MATERIALS AND

methodsPost hoc analysis of adult patients who achieved complete PS independence during treatment with teduglutide 0.05 mg/kg/d. Data were pooled from 5 teduglutide clinical trials (2 phase III placebo-controlled trials [NCT00081458 and NCT00798967] and their respective extension studies [NCT00172185, NCT00930644, NCT01560403]). Descriptive statistics were used; no between-group comparisons were performed because of the small sample size and lack of comparator.

resultsOf 134 patients, 16 gained oral or enteral autonomy after a median of 5 years of PS dependence and 89 weeks of teduglutide treatment. Demographic and baseline disease characteristics varied among patients (median age, 55 years; 50% men; median baseline PS volume, 5.1 L/wk; median residual small intestine length, 52.5 cm). Most patients who achieved PS independence had colon-in-continuity; however, there was no significant difference in the frequency of PS independence among patients who maintained colon-in-continuity vs those who did not.

conclusionFindings from this post hoc analysis suggest that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term PS dependence.

Indexed as

Parenteral NutritionAdultEndpoint DeterminationFemaleGastrointestinal AgentsHumansIntestinal DiseasesIntestinesMaleMiddle AgedParenteral Nutrition SolutionsPeptidesShort Bowel SyndromeGastrointestinal AgentsParenteral Nutrition SolutionsPeptidesteduglutidegastroenterologyintestinal failurenutritionparenteral nutritionshort bowel syndrometeduglutide

Identifiers

PMID27875291
PMCPMC5639959
OpenAlexW2552934799

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.