title: Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects.
abstract: Loss of intestinal absorptive capacity from congenital defect, surgical resection or mucosal disease results in short bowel syndrome (SBS)-associated intestinal failure. In the past, few medical management options were available besides dietary modification, controlling diarrhea or high stomal output, and providing parenteral fluid, electrolyte and nutrient support (parenteral support). Recent research on strategies to enhance the intestinal absorptive capacity focused on glucagon-like peptide-2, an intestinotrophic hormone that has been shown to increase the villus height and crypt depth, and decrease gastric motility and intestinal secretory losses. STEPS is a Phase III randomized double-blinded controlled trial in which teduglutide, a recombinant analog of glucagon-like peptide-2, or placebo was given subcutaneously to SBS patients for 24 weeks. A clinically meaningful response, defined as a 20-100% reduction in parenteral support volume, was achieved in 63% of the treatment group compared with 30% in the placebo group (p = 0.002) without an increase in serious side effects. Teduglutide offers a new targeted approach to SBS-associated intestinal failure management. Its specific role in clinical practice remains to be evaluated.
authors.affiliation: Clinical Instructor of Medicine, Division of General Internal Medicine, University of Pittsburgh Medical Center, 200 Lothrop Street, 933W MUH, Pittsburgh, PA 15213, USA.
authors.forename: Kishore
authors.initials: K
authors.lastname: Vipperla
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: O'Keefe
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D007421:Intestine, Small / Q000187:drug effects / Q000378:metabolism; D010288:Parenteral Nutrition; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012778:Short Bowel Syndrome / Q000175:diagnosis / Q000188:drug therapy / Q000378:metabolism / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D010455:Peptides; C494910:teduglutide