title: Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study.
abstract: OBJECTIVE
  Short bowel syndrome (SBS)-intestinal failure (IF) patients have impaired quality of life (QoL) and suffer from the burden of malabsorption and parenteral support (PS). A phase III study demonstrated that treatment with teduglutide, a glucagon-like peptide 2 analogue, reduces PS volumes by 32% while maintaining oral fluid intake constant; placebo-treated patients had reduced PS by 21%, but oral fluid intake increased accordingly. As effects of teduglutide on QoL are unknown, they were investigated here.
  
  
  METHODS
  QoL analyses from a double-blind, randomised Phase III study in 86 SBS-IF patients receiving teduglutide (0.05 mg/kg/day s.c.) or placebo over 24 weeks. At baseline and every 4 weeks, QoL was assessed using the validated SBS-QoL™ scale.
  
  
  RESULTS
  PS reductions were associated with QoL improvements (ANCOVA, p = 0.0194, SBS-QoL per-protocol). Compared to baseline, teduglutide significantly improved the SBS-QoL™ total score and the score of 9 of 17 items at week 24. These changes were not significant compared to placebo. Teduglutide-treated patients with remaining small intestine >100 cm experienced more gastrointestinal adverse events (GI-AE), unfavourably affecting QoL.
  
  
  CONCLUSIONS
  Overall, PS volume reductions were associated with improvements in SBS-QoL™ scores. The short observation period, imbalances in oral fluid intake in relation to PS reductions, large patient and effect heterogeneity and occurrence of GI-AE in a subgroup of teduglutide-treated patients may account for the inability to show statistically significant effects of teduglutide on SBS-QoL™ scores compared to placebo.
authors.affiliation: Department of Medical Gastroenterology, CA-2121 Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. Electronic address: Bekker@dadlnet.dk.
authors.forename: P B
authors.initials: PB
authors.lastname: Jeppesen
authors.forename: M
authors.initials: M
authors.lastname: Pertkiewicz
authors.forename: A
authors.initials: A
authors.lastname: Forbes
authors.forename: L
authors.initials: L
authors.lastname: Pironi
authors.forename: S M
authors.initials: SM
authors.lastname: Gabe
authors.forename: F
authors.initials: F
authors.lastname: Joly
authors.forename: B
authors.initials: B
authors.lastname: Messing
authors.forename: S
authors.initials: S
authors.lastname: Loth
authors.forename: N N
authors.initials: NN
authors.lastname: Youssef
authors.forename: H
authors.initials: H
authors.lastname: Heinze
authors.forename: P
authors.initials: P
authors.lastname: Berghöfer
mesh_terms: D000328:Adult; D000368:Aged; D017281:Cost of Illness; D004311:Double-Blind Method; D004326:Drinking; D004351:Drug Resistance; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D053767:Glucagon-Like Peptide 2 / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use; D000067758:Glucagon-Like Peptide-2 Receptor; D006801:Humans; D007279:Injections, Subcutaneous; D007410:Intestinal Diseases / Q000188:drug therapy / Q000473:pathology / Q000503:physiopathology / Q000628:therapy; D007421:Intestine, Small / Q000473:pathology / Q000503:physiopathology; D008875:Middle Aged; D063305:Organ Dysfunction Scores; D009929:Organ Size; D016331:Parenteral Nutrition, Home / Q000009:adverse effects; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D018027:Receptors, Glucagon / Q000819:agonists*; D012778:Short Bowel Syndrome / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000628:therapy
chemical_list: C578749:GLP2R protein, human; D005765:Gastrointestinal Agents; D053767:Glucagon-Like Peptide 2; D000067758:Glucagon-Like Peptide-2 Receptor; D010455:Peptides; D018027:Receptors, Glucagon; C494910:teduglutide
keywords: Glucagon-like peptide 2 (GLP-2) analogue; Quality of life (QoL); Short bowel syndrome (SBS); Teduglutide; Treatment response