title: Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure.
abstract: OBJECTIVE
  Teduglutide, a glucagon-like peptide 2 analogue, might restore intestinal structural and functional integrity by promoting growth of the mucosa and reducing gastric emptying and secretion. These factors could increase fluid and nutrient absorption in patients with short bowel syndrome with intestinal failure (SBS-IF). We performed a prospective study to determine whether teduglutide reduces parenteral support in patients with SBS-IF.
  
  
  METHODS
  We performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily. Parenteral support was reduced if 48-hour urine volumes exceeded baseline values by ≥ 10%. The primary efficacy end point was number of responders (patients with >20% reduction in parenteral support volume from baseline at weeks 20 and 24).
  
  
  RESULTS
  There were significantly more responders in the teduglutide group (27/43 [63%]) than the placebo group (13/43 [30%]; P = .002). At week 24, the mean reduction in parenteral support volume in the teduglutide group was 4.4 ± 3.8 L/wk (baseline 12.9 ± 7.8 L/wk) compared with 2.3 ± 2.7 L/wk (baseline 13.2 ± 7.4 L/wk) in the placebo group (P < .001). The percentage of patients with a 1-day or more reduction in the weekly need for parenteral support was greater in the teduglutide group (21/39 [54%]) than in the placebo group (9/39 [23%]; P = .005). Teduglutide increased plasma concentrations of citrulline, a biomarker of mucosal mass. The distribution of treatment-emergent adverse events that led to study discontinuation was similar between patients given teduglutide (n = 2) and placebo (n = 3).
  
  
  CONCLUSIONS
  Twenty-four weeks of teduglutide treatment was generally well tolerated in patients with SBS-IF. Treatment with teduglutide reduced volumes and numbers of days of parenteral support for patients with SBS-IF; ClinicalTrials.gov Number, NCT00798967.
authors.affiliation: Department of Medical Gastroenterology, Rigshospitalet, Copenhagen, Denmark. Bekker@dadlnet.dk
authors.forename: Palle B
authors.initials: PB
authors.lastname: Jeppesen
authors.forename: Marek
authors.initials: M
authors.lastname: Pertkiewicz
authors.forename: Bernard
authors.initials: B
authors.lastname: Messing
authors.forename: Kishore
authors.initials: K
authors.lastname: Iyer
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Seidner
authors.forename: Stephen J D
authors.initials: SJ
authors.lastname: O'keefe
authors.forename: Alastair
authors.initials: A
authors.lastname: Forbes
authors.forename: Hartmut
authors.initials: H
authors.lastname: Heinze
authors.forename: Bo
authors.initials: B
authors.lastname: Joelsson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D002956:Citrulline / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007408:Intestinal Absorption / Q000502:physiology*; D007410:Intestinal Diseases / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D007422:Intestines / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D010288:Parenteral Nutrition; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012778:Short Bowel Syndrome / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D014741:Video Recording; D055815:Young Adult
chemical_list: D015415:Biomarkers; D010455:Peptides; D002956:Citrulline; C494910:teduglutide