%0 Generic
%A Burgos Pelaez, Rosa
%A Cuerda Compes, Ma Cristina
%A Garcia-Luna, Pedro P.
%A Martinez Faedo, Ceferino
%A Mauri Roca, Silvia
%A Moreno Villares, Jose Manuel
%A Virgili Casas, M. Nuria
%A Wanden-Berghe, Carmina
%T Teduglutide: a review of its use in short bowel syndrome
%D 2016
%@ 0212-1611
%U http://hdl.handle.net/10668/19455
%X 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
%K Intestinal failure
%K Teduglutide
%K Short-bowel syndrome
%K GLP-2
%K Parenteral nutrition
%K Home parenteral-nutrition
%K Intestinal failure
%K Adult patients
%K Management
%K Pharmacokinetics
%K Administrations
%K Rehabilitation
%K Complications
%K Multicenter
%K Dependence
%~