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Impact of Teduglutide on Quality of Life Among Patients With Short Bowel Syndrome and Intestinal Failure
Author(s) -
Chen Kristina,
Mu Fan,
Xie Jipan,
Kelkar Sneha S.,
Olivier Clément,
Signorovitch James,
Jeppesen Palle B.
Publication year - 2020
Publication title -
journal of parenteral and enteral nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.935
H-Index - 98
eISSN - 1941-2444
pISSN - 0148-6071
DOI - 10.1002/jpen.1588
Subject(s) - medicine , short bowel syndrome , quality of life (healthcare) , placebo , parenteral nutrition , gastroenterology , inflammatory bowel disease , crohn's disease , disease , nursing , alternative medicine , pathology
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.