RT Generic T1 Teduglutide: a review of its use in short bowel syndrome A1 Burgos Pelaez, Rosa A1 Cuerda Compes, Ma Cristina A1 Garcia-Luna, Pedro P. A1 Martinez Faedo, Ceferino A1 Mauri Roca, Silvia A1 Moreno Villares, Jose Manuel A1 Virgili Casas, M. Nuria A1 Wanden-Berghe, Carmina K1 Intestinal failure K1 Teduglutide K1 Short-bowel syndrome K1 GLP-2 K1 Parenteral nutrition K1 Home parenteral-nutrition K1 Intestinal failure K1 Adult patients K1 Management K1 Pharmacokinetics K1 Administrations K1 Rehabilitation K1 Complications K1 Multicenter K1 Dependence AB Introduction: Long-term Parenteral Support (PS) can be associated with serious complications, with a significant deterioration in the quality of life of patients with short bowel syndrome (SBS). Teduglutide is a recombinant analogue of glucagon-like peptide-2; it belongs to a novel therapeutic family and represents the first non-symptomatic approach against SBS.Objectives: To review the non-clinical and clinical data on efficacy and safety of teduglutide.Results: Teduglutide approval was based on results from a pivotal Phase III, 24-week, double-blind, placebo-controlled study (STEPS). SBS patients dependent on PS >= 3 times/week for >= 12 months received 0.05 mg/kg teduglutide (n = 43) or placebo (n = 43) 1 time/day. At week 24 there were significantly more responders in the teduglutide group vs. placebo (63 vs. 30%; p = 0.002). The overall mean reduction vs. PS baseline volume at week 24 was significantly higher with teduglutide vs. placebo (4.4 vs. 2.3 l/ week, p = 3 times/week for >= 12 months received 0.05 mg/kg teduglutide (n = 43) or placebo (n = 43) 1 time/day. At week 24 there were significantly more responders in the teduglutide group vs. placebo (63 vs. 30%; p = 0.002). The overall mean reduction vs. PS baseline volume at week 24 was significantly higher with teduglutide vs. placebo (4.4 vs. 2.3 l/ week, p = 12 months received 0.05 mg/kg teduglutide (n = 43) or placebo (n = 43) 1 time/day. At week 24 there were significantly more responders in the teduglutide group vs. placebo (63 vs. 30%; p = 0.002). The overall mean reduction vs. PS baseline volume at week 24 was significantly higher with teduglutide vs. placebo (4.4 vs. 2.3 l/ week, p PB Aran ediciones, s l SN 0212-1611 YR 2016 FD 2016-07-01 LK http://hdl.handle.net/10668/19455 UL http://hdl.handle.net/10668/19455 LA es DS RISalud RD Apr 19, 2025