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Impact of Teduglutide on Quality of Life Among Patients With Short Bowel Syndrome and Intestinal Failure

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  1. Gastric Residual to Predict Necrotizing Enterocolitis in Preterm Piglets As Models for Infants

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer 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.

TidsskriftJournal of Parenteral and Enteral Nutrition
Udgave nummer1
Sider (fra-til)119-128
Antal sider10
StatusUdgivet - 2020

Bibliografisk note

Funding Information:
Medical writing assistance was provided by Shelley A. Batts, PhD, an employee of Analysis Group, Inc., and funded by Shire International GmbH, Zug, Switzerland, a member of the Takeda group of companies. K. Chen, F. Mu, J. Xie, S. S. Kelkar, C. Olivier, J. Signorovitch, and P. B. Jeppesen equally contributed to the conception and design of the research; F. Mu, J. Xie, S. S. Kelkar, and J. Signorovitch contributed to the acquisition, analysis, and interpretation of the data. All authors drafted the manuscript, critically revised the manuscript, agree to be fully accountable for ensuring the integrity and accuracy of the work, and read and approved the final manuscript.

ID: 59434629