{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T13:18:00Z","timestamp":1789391880593,"version":"build-2803163510"},"reference-count":13,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2016,9,27]],"date-time":"2016-09-27T00:00:00Z","timestamp":1474934400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sucampo Pharma Americas, LLC"},{"name":"Takeda Pharmaceuticals International, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2016,11]]},"abstract":"Summary<\/jats:title>Background<\/jats:title>Lubiprostone (8 \u03bcg b.d.) received US Food and Drug Administration (FDA<\/jats:styled-content>) approval in 2008 for the treatment of constipation\u2010predominant irritable bowel syndrome (IBS<\/jats:styled-content>\u2010C) in women aged \u226518 years. In 2012, the FDA<\/jats:styled-content> issued new guidance for IBS<\/jats:styled-content>\u2010C clinical trials, recommending a composite endpoint incorporating both abdominal pain and stool frequency.<\/jats:p><\/jats:sec>Aim<\/jats:title>In a post hoc<\/jats:italic> analysis, similar criteria were applied to data from two pivotal, phase 3, double\u2010blind, randomised trials of lubiprostone in patients with IBS<\/jats:styled-content>\u2010C.<\/jats:p><\/jats:sec>Methods<\/jats:title>Included patients had a baseline spontaneous bowel movement (SBM<\/jats:styled-content>) frequency <3\/week and abdominal pain or bloating ratings \u22651.36 on a 5\u2010point scale [0 (absent) to 4 (very severe)]. Responders (composite endpoint) had a mean pain reduction \u226530% compared with baseline, and an increase from baseline of \u22651 SBM<\/jats:styled-content>\/week for \u22656 of the 12 treatment weeks. Lubiprostone effects on abdominal pain alone were also evaluated, as were bloating alone and in a composite endpoint with stool frequency.<\/jats:p><\/jats:sec>Results<\/jats:title>In pooled data, 325 patients received lubiprostone and 180 received placebo. Rates of response were higher with lubiprostone vs. placebo for the composite endpoint of improved pain and stool frequency (26.3% vs. 15.3%, respectively; P<\/jats:italic> = 0.008) and the composite endpoint of improved bloating and stool frequency (23.8% vs. 12.6%, respectively; P<\/jats:italic> = 0.012). Response rates were also higher with lubiprostone vs. placebo for abdominal pain alone (P<\/jats:italic> = 0.005) and bloating alone (P<\/jats:italic> = 0.012).<\/jats:p><\/jats:sec>Conclusion<\/jats:title>Lubiprostone was significantly more effective than placebo in improving abdominal pain or bloating, and also in composite endpoints that included stool frequency.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.13807","type":"journal-article","created":{"date-parts":[[2016,9,27]],"date-time":"2016-09-27T07:06:03Z","timestamp":1474959963000},"page":"1114-1122","source":"Crossref","is-referenced-by-count":40,"title":["Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation"],"prefix":"10.1111","volume":"44","author":[{"given":"L.","family":"Chang","sequence":"first","affiliation":[{"name":"David Geffen School of Medicine at UCLA Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. D.","family":"Chey","sequence":"additional","affiliation":[{"name":"University of Michigan School of Medicine Ann Arbor MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Drossman","sequence":"additional","affiliation":[{"name":"University of North Carolina and Drossman Gastroenterology Chapel Hill NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Losch\u2010Beridon","sequence":"additional","affiliation":[{"name":"Sucampo Pharma Americas LLC Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Wang","sequence":"additional","affiliation":[{"name":"Sucampo Pharma Americas LLC Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Lichtlen","sequence":"additional","affiliation":[{"name":"Sucampo AG Zug Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Mareya","sequence":"additional","affiliation":[{"name":"Sucampo Pharma Americas LLC Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,9,27]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2012.02.029"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.061"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2011.04983.x"},{"key":"e_1_2_7_5_1","first-page":"8898","article-title":"Constipation\u2010predominant irritable bowel syndrome: a review of current and emerging drug therapies","volume":"20","author":"Jadallah KA","year":"2014","journal-title":"World J Gastroenterol"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.5056\/jnm15171"},{"key":"e_1_2_7_7_1","unstructured":"Amitiza\u00ae(Lubiprostone). Full Prescribing Information Sucampo Pharma Americas LLC and Takeda Pharmaceuticals America Inc. Bethesda MD and Deerfield IL 2013."},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03881.x"},{"key":"e_1_2_7_9_1","volume-title":"Guidance for Industry Irritable Bowel Syndrome\u2010Clinical Evaluation of Drugs for Treatment","author":"US Food and Drug Administration","year":"2012"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.12"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.254"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.12264"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03629.x"},{"key":"e_1_2_7_14_1","unstructured":"The Rome Foundation.Appendix B: Comparison Table of Rome II & Rome III Adult Diagnostic Criteria. The Rome Foundation; 2006: 899\u2010915. Available athttp:\/\/www.romecriteria.org\/assets\/pdf\/20_RomeIII_apB_899-916.pdf(accessed 2\/4\/2016)."}],"container-title":["Alimentary Pharmacology & Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.13807","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.13807","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.13807","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T14:58:22Z","timestamp":1695481102000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.13807"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,9,27]]},"references-count":13,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2016,11]]}},"alternative-id":["10.1111\/apt.13807"],"URL":"https:\/\/doi.org\/10.1111\/apt.13807","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,9,27]]}}}