title: Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure.
abstract: OBJECTIVE
  Although home parenteral nutrition (PN) can save the lives of patients with massive bowel loss that results in short-bowel syndrome and intestinal failure, quality of life is impaired by PN and its complications. We examined the 12-month tolerability and efficacy of teduglutide to reduce PN dependency.
  
  
  METHODS
  Patients who received teduglutide (0.05 or 0.10 mg/kg/d) for 24 weeks in a randomized controlled trial were eligible for a 28-week double-blind extension study; 52 patients were given 52 weeks of the same doses of teduglutide. We investigated the safety, tolerability, and clinical efficacy (defined as a clinically meaningful ≥20% reduction in weekly PN volume from baseline) at week 52.
  
  
  RESULTS
  The most common adverse events reported included headache (35%), nausea (31%), and abdominal pain (25%); 7 patients withdrew because of adverse events (gastrointestinal disorders in 4). Both groups had progressive reduction in PN. At week 52, 68% of the 0.05-mg/kg/d and 52% of the 0.10-mg/kg/d dose group had a ≥20% reduction in PN, with a reduction of 1 or more days of PN dependency in 68% and 37%, respectively. Four patients achieved complete independence from PN.
  
  
  CONCLUSIONS
  For patients with short-bowel syndrome intestinal failure, the efficacy of teduglutide was maintained over 52 weeks and the safety profile was sufficient for it to be considered for long-term use. Further studies are needed to determine whether these effects will translate into improved quality of life and reduced PN complications. ClinicalTrials.gov number, NCT00172185.
authors: Division of Gastroenterology, University of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA. sjokeefe@pitt.edu
authors: Stephen J D
authors: SJ
authors: O'Keefe
authors: Palle B
authors: PB
authors: Jeppesen
authors: Richard
authors: R
authors: Gilroy
authors: Marek
authors: M
authors: Pertkiewicz
authors: Johane P
authors: JP
authors: Allard
authors: Bernard
authors: B
authors: Messing
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010288:Parenteral Nutrition; D010455:Peptides / Q000009:adverse effects* / Q000627:therapeutic use*; D012778:Short Bowel Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005765:Gastrointestinal Agents; D010455:Peptides; C494910:teduglutide