{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:43:27Z","timestamp":1790621007422,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,9,8]],"date-time":"2019-09-08T00:00:00Z","timestamp":1567900800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["aspenjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Parenter Enteral Nutr"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This study evaluated the safety and efficacy of teduglutide in pediatric patients with short bowel syndrome\u2013associated intestinal failure (SBS\u2010IF).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A 24\u2010week, phase III trial with 2 randomized, double\u2010blind teduglutide dose groups and a nonblinded standard of care (SOC) arm was used; patients received 0.025\u00a0mg\/kg or 0.05\u00a0mg\/kg teduglutide once daily. Safety end points included treatment\u2010emergent adverse events (TEAEs) and growth parameters. The primary efficacy\/pharmacodynamic end point was the number of patients who achieved a \u226520% reduction in parenteral support (PS) from baseline at week 24.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      All 59 enrolled patients completed the study (0.025\u00a0mg\/kg, n = 24; 0.05\u00a0mg\/kg, n = 26; SOC, n = 9). Baseline demographics and disease characteristics were comparable among groups. TEAEs were reported by 98% and 100% of patients in the teduglutide and SOC groups, respectively. The most common TEAEs in the teduglutide\u2010treated groups were pyrexia and vomiting. The primary end point was achieved by 13 (54.2%), 18 (69.2%), and 1 (11.1%) patients who received 0.025\u00a0mg\/kg teduglutide, 0.05\u00a0mg\/kg teduglutide, and SOC, respectively (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.05 vs SOC). Both 0.025\u2010mg\/kg and 0.05\u2010mg\/kg teduglutide groups showed clinically significant reductions in PS volume (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.05 vs SOC), PS calories,\u00a0days per week and hours per day of PS infusions, and increases in enteral nutrition and plasma citrulline at week 24 compared with baseline. Two (8.3%, 0.025\u00a0mg\/kg teduglutide) and 3 patients (11.5%, 0.05\u00a0mg\/kg teduglutide) achieved enteral autonomy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The safety profile of teduglutide was similar to that reported previously in children and adults. Treatment with teduglutide was associated with significant reductions in PS for pediatric patients with SBS\u2010IF over 24 weeks.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jpen.1690","type":"journal-article","created":{"date-parts":[[2019,9,9]],"date-time":"2019-09-09T01:29:18Z","timestamp":1567992558000},"page":"621-631","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":142,"title":["Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24\u2010Week, Phase III Study"],"prefix":"10.1002","volume":"44","author":[{"given":"Samuel A.","family":"Kocoshis","sequence":"first","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell J.","family":"Merritt","sequence":"additional","affiliation":[{"name":"Children's Hospital Los Angeles and Keck School of Medicine University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Hill","sequence":"additional","affiliation":[{"name":"Great Ormond Street Hospital for Children NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Protheroe","sequence":"additional","affiliation":[{"name":"Birmingham Children's Hospital NHS Foundation Trust  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth A.","family":"Carter","sequence":"additional","affiliation":[{"name":"Texas Children's Hospital Baylor College of Medicine  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Horslen","sequence":"additional","affiliation":[{"name":"Seattle Children's Hospital and University of Washington School of Medicine  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simin","family":"Hu","sequence":"additional","affiliation":[{"name":"Shire Human Genetic Therapies, Inc  Lexington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart S.","family":"Kaufman","sequence":"additional","affiliation":[{"name":"MedStar Georgetown University Hospital  Washington District of Columbia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David F.","family":"Mercer","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center  Omaha Nebraska USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikko P.","family":"Pakarinen","sequence":"additional","affiliation":[{"name":"Children's Hospital Pediatric Research Center University of Helsinki, Helsinki University Hospital  Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert 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