title: Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome.
abstract: In 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.
  
  
  
  Post 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.
  
  
  
  Of 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.
  
  
  
  Findings 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.
authors.affiliation: 1 Adult and Pediatric Intestinal Transplant & Rehabilitation Program, Mount Sinai Medical Center, New York, New York, USA.
authors.forename: Kishore R
authors.initials: KR
authors.lastname: Iyer
authors.affiliation: 2 Department of Clinical Nutrition, M. Pirogow Hospital, Lódz, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Kunecki
authors.affiliation: 3 Department of Biobehavioral and Health Sciences, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Joseph I
authors.initials: JI
authors.lastname: Boullata
authors.affiliation: 4 Department of Endocrinology, Scripps Clinic, La Jolla, California, USA.
authors.forename: Ken
authors.initials: K
authors.lastname: Fujioka
authors.affiliation: 5 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.
authors.forename: Francisca
authors.initials: F
authors.lastname: Joly
authors.affiliation: 6 Lennard Jones Intestinal Failure Unit, St Mark's Hospital, Northwick Park, London, United Kingdom.
authors.forename: Simon
authors.initials: S
authors.lastname: Gabe
authors.affiliation: 7 Department of Hepatology & Gastroenterology, Charité University Medicine, Berlin, Germany.
authors.forename: Ulrich-Frank
authors.initials: UF
authors.lastname: Pape
authors.affiliation: 8 Gastroentérologie et Nutrition Clinique, Université de Nice Sophia-Antipolis, Nice, France.
authors.forename: Stéphane M
authors.initials: SM
authors.lastname: Schneider
authors.affiliation: 9 Unit of Nutrition and Dietetics, Department of Endocrinology and Nutrition, Bellvitge University Hospital, Barcelona, Spain.
authors.forename: María Nuria
authors.initials: MN
authors.lastname: Virgili Casas
authors.affiliation: 10 Department of Medicine, Division of Endocrinology, Metabolism and Lipids and Center for Clinical and Molecular Nutrition, Emory University School of Medicine, Atlanta, Georgia, USA.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Ziegler
authors.affiliation: 11 Department of Statistics, NPS Pharmaceuticals, Inc, Lexington, Massachusetts, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Li
authors.affiliation: 12 Clinical Research and Development, NPS Pharmaceuticals, Inc, Lexington, Massachusetts, USA.
authors.forename: Nader N
authors.initials: NN
authors.lastname: Youssef
authors.affiliation: 13 Department of Medical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Palle B
authors.initials: PB
authors.lastname: Jeppesen
mesh_terms: D000328:Adult; D023381:Endpoint Determination; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D007410:Intestinal Diseases / Q000628:therapy*; D007422:Intestines / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010288:Parenteral Nutrition; D057947:Parenteral Nutrition Solutions / Q000008:administration & dosage*; D010455:Peptides / Q000627:therapeutic use*; D012778:Short Bowel Syndrome / Q000628:therapy*
chemical_list: D005765:Gastrointestinal Agents; D057947:Parenteral Nutrition Solutions; D010455:Peptides; C494910:teduglutide
keywords: gastroenterology; intestinal failure; nutrition; parenteral nutrition; short bowel syndrome; teduglutide