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The Capital Region of Denmark - a part of Copenhagen University Hospital
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Impact of Teduglutide on Quality of Life Among Patients With Short Bowel Syndrome and Intestinal Failure

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Colon polyps in patients with short bowel syndrome before and after teduglutide: Post hoc analysis of the STEPS study series

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Enteral Autonomy and Days Off Parenteral Support With Teduglutide Treatment for Short Bowel Syndrome in the STEPS Trials

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Repeated Metabolic Balance Studies in Patients With Short Bowel Syndrome

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Kristina Chen
  • Fan Mu
  • Jipan Xie
  • Sneha S Kelkar
  • Clément Olivier
  • James Signorovitch
  • Palle B Jeppesen
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BACKGROUND: Teduglutide reduces or eliminates parenteral support (PS) dependency in patients with short bowel syndrome (SBS). Recent post hoc analyses demonstrated that effects are correlated with baseline PS volume. We assessed the SBS-related quality-of-life (QoL) impact of teduglutide, particularly whether improvements are greater among subgroups achieving more PS volume reduction.

METHODS: Using phase 3 trial data of teduglutide in patients with SBS (NCT00798967), change in Short Bowel Syndrome-Quality of Life (SBS-QoL) scores from baseline were compared between teduglutide vs placebo in the overall population and subgroups classified by baseline PS volume requirement, disease etiology, and bowel anatomy. Generalized estimating equation models were fitted to assess impact of teduglutide on SBS-related QoL using data from all visits, adjusted for baseline characteristics.

RESULTS: Of 86 patients, 43 each were randomized to teduglutide or placebo (mean age: 51 vs 50 years, respectively). In adjusted analyses, teduglutide had a nonsignificant reduction (improvement) of -8.6 points (95% CI: 2.6 to -19.8) in SBS-QoL sum score from baseline to Week-24 vs placebo. The impact of teduglutide varied by subgroup. Patients treated with teduglutide experienced significantly greater reductions in SBS-QoL sum score at Week-24 vs placebo in 2 subgroups, ie, the third (highest) tertile baseline PS volume (-27.3, 95% CI: -50.8 to -3.7) and inflammatory bowel disease (IBD; -29.6, 95% CI: -46.3 to -12.9). Results were similar for SBS-QoL subscale and item scores.

CONCLUSIONS: The impact of teduglutide treatment on SBS-related QoL vs placebo varied among subgroups and was significant and most pronounced among patients with highest baseline PS volume requirement or IBD.

Original languageEnglish
JournalJournal of Parenteral and Enteral Nutrition
Volume44
Issue number1
Pages (from-to)119-128
Number of pages10
ISSN0148-6071
DOIs
Publication statusPublished - 2020

ID: 59434629