Abstract

BURGOS PELAEZ, Rosa et al. Teduglutide: a review of its use in short bowel syndrome. Nutr. Hosp. [online]. 2016, vol.33, n.4, pp.969-977. ISSN 1699-5198.  https://dx.doi.org/10.20960/nh.400.

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 < 0.001). At week 24 the need for PS was reduced in at least 1 day in 54% of patients treated with teduglutide vs. 23% with placebo. Of the total of patients who received teduglutide in phase III trials (n = 134), 12% achieved complete autonomy from PS. Subcutaneous teduglutide was generally well tolerated. Conclusions: Teduglutide has been shown to enhance intestinal absorptive capacity and significantly reduce PS dependency, even achieving independency in some patients.

Keywords : Intestinal failure; Teduglutide; Short-bowel syndrome; GLP-2; Parenteral nutrition.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )