{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T04:33:17Z","timestamp":1783571597522,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,2,21]],"date-time":"2019-02-21T00:00:00Z","timestamp":1550707200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01-DK115950"],"award-info":[{"award-number":["R01-DK115950"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01-DK67071"],"award-info":[{"award-number":["R01-DK67071"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In two phase 3 trials, elobixibat, a locally acting ileal bile acid transporter inhibitor, resolved constipation and was well tolerated in Japanese patients with chronic constipation. We analyzed the efficacy, safety, and impact on quality of life (QOL) of elobixibat in patients with symptomatically more severe constipation in the two phase 3 trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This post hoc analysis of elobixibat treatment outcomes included data from a 2\u2010week, randomized, placebo\u2010controlled, phase 3 trial (10\u00a0mg\/d), and a 52\u2010week, open\u2010label trial (5\u201015\u00a0mg\/d) in subgroups with severe constipation defined as \u22642 spontaneous bowel movements (SBMs) and \u22643 Bristol Stool Form Scale score during the second week of the 2\u2010week run\u2010in period. We also analyzed the rates of abdominal pain, diarrhea, and QOL in subgroups according to sex, presence of constipation\u2010predominant irritable bowel syndrome (IBS\u2010C) and side effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Key Results<\/jats:title><jats:p>In patients with severe constipation, there was significant improvement in the 10\u00a0mg elobixibat group compared to the placebo group in change in SBMs from baseline at week 1 (primary endpoint) of the 2\u2010week trial. The differences between groups were reduced in patients with more severe constipation. Increasing the dose to 15\u00a0mg was effective for more severe constipation in improving the number of SBMs per week in the 52\u2010week trial. Overall, elobixibat was well tolerated and improved QOL scores, irrespective of gender, presence of IBS\u2010C or side effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions &amp; Inferences<\/jats:title><jats:p>Elobixibat is effective for symptomatically severe constipation, is well tolerated and improves QOL, irrespective of potentially confounding patient characteristics.<\/jats:p><\/jats:sec>","DOI":"10.1111\/nmo.13571","type":"journal-article","created":{"date-parts":[[2019,2,22]],"date-time":"2019-02-22T04:46:53Z","timestamp":1550810813000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Efficacy, long\u2010term safety, and impact on quality of life of elobixibat in more severe constipation: Post hoc analyses of two phase 3 trials in Japan"],"prefix":"10.1111","volume":"31","author":[{"given":"Atsushi","family":"Nakajima","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinya","family":"Taniguchi","sequence":"additional","affiliation":[{"name":"Medical Department EA Pharma Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinsuke","family":"Kurosu","sequence":"additional","affiliation":[{"name":"Clinical Development Department EA Pharma Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per\u2010G\u00f6ran","family":"Gillberg","sequence":"additional","affiliation":[{"name":"Albireo AB Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan P.","family":"Mattsson","sequence":"additional","affiliation":[{"name":"Albireo AB Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6472-7514","authenticated-orcid":false,"given":"Michael","family":"Camilleri","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,2,21]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2004.04114.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.5056\/jnm15187"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-011-1639-5"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-301181"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2982.2010.01597.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2013.04.020"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2017.06.039"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/1756283X14528269"},{"key":"e_1_2_9_11_1","first-page":"593","article-title":"Relationships between ion and water movement in the human jejunum, ileum and colon during perfusion with bile acids","volume":"45","author":"Wingate DL","year":"1973","journal-title":"Clin Sci Mol Med"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajpgi.00194.2001"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.285"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.162"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.13448"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13698"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-017-1383-5"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(18)30123-7"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02235036"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2009.612"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.5056\/jnm17022"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.061"},{"key":"e_1_2_9_23_1","first-page":"661","article-title":"Effect of molecular structure on bile acid\u2010induced alterations in absorptive function, permeability, and morphology in the perfused rabbit colon","volume":"94","author":"Chadwick VS","year":"1979","journal-title":"J Lab Clin Med"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2010.227132"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.10.028"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2982.2009.01442.x"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.29.9.1173"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2004.40453.x"}],"container-title":["Neurogastroenterology &amp; 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