Burgos Pelaez, RosaCuerda Compes, Ma CristinaGarcia-Luna, Pedro P.Martinez Faedo, CeferinoMauri Roca, SilviaMoreno Villares, Jose ManuelVirgili Casas, M. NuriaWanden-Berghe, Carmina2023-02-122023-02-122016-07-010212-1611http://hdl.handle.net/10668/19455Introduction: 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, pesAttribution-NonCommercial-ShareAlike 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-sa/4.0/Intestinal failureTeduglutideShort-bowel syndromeGLP-2Parenteral nutritionHome parenteral-nutritionIntestinal failureAdult patientsManagementPharmacokineticsAdministrationsRehabilitationComplicationsMulticenterDependencereviewopen access10.20960/nh.4001699-5198https://doi.org/10.20960/nh.400388654900031