{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:44:46Z","timestamp":1790621086247,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,5,15]],"date-time":"2018-05-15T00:00:00Z","timestamp":1526342400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007343","name":"Shire","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007343","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["aspenjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Nut in Clin Prac"],"published-print":{"date-parts":[[2018,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Patients with intestinal failure associated with short bowel syndrome (SBS\u2013IF) require parenteral support (PS) to maintain fluid balance or nutrition. Teduglutide (TED) reduced PS requirements in patients with SBS\u2013IF in the randomized, placebo (PBO)\u2010controlled STEPS study (NCT00798967) and its 2\u2010year, open\u2010label extension, STEPS\u20102 (NCT00930644).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>STEPS\u20103 (NCT01560403), a 1\u2010year, open\u2010label extension study in patients with SBS\u2013IF who completed STEPS\u20102, further monitored the safety and efficacy of TED (0.05\u00a0mg\/kg\/day). Baseline was the start of TED treatment, in either STEPS or STEPS\u20102. At the end of STEPS\u20103, patients treated with TED in both STEPS and STEPS\u20102 (TED\u2013TED) received TED for\u00a0\u226442\u00a0months, and patients treated with TED only in STEPS\u20102 (no TED treatment [NT]\/PBO\u2013TED) received TED for\u00a0\u226436 months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fourteen patients enrolled (TED\u2012TED, n\u00a0=\u00a05; NT\/PBO\u2012TED, n\u00a0=\u00a09) and 13 completed STEPS\u20103. 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\u2012TED and NT\/PBO\u2012TED, respectively. Mean (SD) PS infusions decreased by 3.0 (4.6) and 2.1 (2.2) days per week from baseline in TED\u2012TED and NT\/PBO\u2012TED, respectively. Two patients achieved PS independence; 2 additional patients who achieved independence in STEPS\u20102 maintained enteral autonomy throughout STEPS\u20103. All patients reported\u00a0\u22651 treatment\u2010emergent adverse event (TEAE); 3 patients had TEAEs that were reported as treatment related. No patient had a treatment\u2010related treatment\u2010emergent serious AE.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Long\u2010term TED treatment yielded a safety profile consistent with previous studies, sustained efficacy, and a further decline in PS requirements.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ncp.10092","type":"journal-article","created":{"date-parts":[[2018,5,15]],"date-time":"2018-05-15T07:10:52Z","timestamp":1526368252000},"page":"520-527","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":79,"title":["Reduction of Parenteral Nutrition and Hydration Support and Safety With Long\u2010Term Teduglutide Treatment in Patients With Short Bowel Syndrome\u2212Associated Intestinal Failure: STEPS\u20103 Study"],"prefix":"10.1002","volume":"33","author":[{"given":"Douglas L.","family":"Seidner","sequence":"first","affiliation":[{"name":"Vanderbilt University Medical Center  Nashville TN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Fujioka","sequence":"additional","affiliation":[{"name":"Scripps Clinic  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph I.","family":"Boullata","sequence":"additional","affiliation":[{"name":"Hospital of the University of Pennsylvania and Drexel University  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kishore","family":"Iyer","sequence":"additional","affiliation":[{"name":"Mount Sinai Medical Center  New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hak\u2010Myung","family":"Lee","sequence":"additional","affiliation":[{"name":"Shire Human Genetic Therapies, Inc.  Lexington MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas R.","family":"Ziegler","sequence":"additional","affiliation":[{"name":"Emory University School of Medicine  Atlanta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,5,15]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0148607114520994"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0148607112469818"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/0148607113517717"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0261-5614(03)00042-6"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0148607113512678"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365520802078325"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12092"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.09.007"},{"key":"e_1_2_7_10_1","volume-title":"Full prescribing information","author":"GATTEX\u00ae(teduglutide [rDNA origin])","year":"2016"},{"key":"e_1_2_7_11_1","volume-title":"EMA summary of product characteristics","author":"Revestive\u00ae (teduglutide)","year":"2016"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/ctg.2015.69"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2004.061440"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0261-5614(16)30717-8"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0894-0959.2004.17603.x"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/00129804-200609000-00004"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/MCO.0b013e328329e4ef"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12209"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1053\/gast.2001.22555"}],"container-title":["Nutrition in Clinical Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fncp.10092","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aspenjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ncp.10092","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T13:39:13Z","timestamp":1760967553000},"score":1,"resource":{"primary":{"URL":"https:\/\/aspenjournals.onlinelibrary.wiley.com\/doi\/10.1002\/ncp.10092"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,5,15]]},"references-count":18,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2018,8]]}},"alternative-id":["10.1002\/ncp.10092"],"URL":"https:\/\/doi.org\/10.1002\/ncp.10092","archive":["Portico"],"relation":{},"ISSN":["0884-5336","1941-2452"],"issn-type":[{"value":"0884-5336","type":"print"},{"value":"1941-2452","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,5,15]]},"assertion":[{"value":"2017-08-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-03-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-05-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}