Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study

Nutrition in Clinical Practice : Official Publication of the American Society for Parenteral and Enteral Nutrition
Douglas L SeidnerThomas R Ziegler

Abstract

Patients with intestinal failure associated with short bowel syndrome (SBS-IF) require parenteral support (PS) to maintain fluid balance or nutrition. Teduglutide (TED) reduced PS requirements in patients with SBS-IF in the randomized, placebo (PBO)-controlled STEPS study (NCT00798967) and its 2-year, open-label extension, STEPS-2 (NCT00930644). STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day). Baseline was the start of TED treatment, in either STEPS or STEPS-2. At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months. Fourteen patients enrolled (TED-TED, n = 5; NT/PBO-TED, n = 9) and 13 completed STEPS-3. At the last dosing visit, mean (SD) PS was reduced from baseline by 9.8 (14.4 [50%]) and 3.9 (2.8 [48%]) L/week in TED-TED and NT/PBO-TED, respectively. Mean (SD) PS infusions decreased by 3.0 (4.6) and 2.1 (2.2) days per week from baseline in TED-TED and NT/PBO-TED, respectively. Two patients achieved PS independence; 2 additional patients who...Continue Reading

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Citations

Jun 1, 2018·Expert Opinion on Drug Safety·Bharati Kochar, Hans H Herfarth
Dec 27, 2018·Current Opinion in Gastroenterology·Fedja A Rochling, Hilary A Catron
Feb 20, 2020·Current Opinion in Gastroenterology·Liat DeutschSimon Lal
May 12, 2020·JPEN. Journal of Parenteral and Enteral Nutrition·Frances PuelloDejan Micic
Feb 1, 2020·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Racha T Khalaf, Ronald J Sokol
Sep 10, 2019·JPEN. Journal of Parenteral and Enteral Nutrition·Samuel A KocoshisAndrew A Grimm
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Feb 15, 2020·Expert Opinion on Pharmacotherapy·Mariana Hollanda Martins Da RochaJoel Faintuch
Aug 20, 2019·JPEN. Journal of Parenteral and Enteral Nutrition·Douglas L SeidnerPalle Bekker Jeppesen
Feb 23, 2019·Expert Review of Gastroenterology & Hepatology·Lore Billiauws, Francisca Joly
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Oct 7, 2021·JPEN. Journal of Parenteral and Enteral Nutrition·Felix HarpainAnton Stift

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