{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T13:17:59Z","timestamp":1789391879961,"version":"build-2803163510"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,3,3]],"date-time":"2022-03-03T00:00:00Z","timestamp":1646265600000},"content-version":"vor","delay-in-days":30,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100014091","name":"AstraZeneca Pharma Poland","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014091","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Digest Diseases"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To conduct a sub\u2010cohort analysis to evaluate the efficacy and safety of linaclotide in Chinese patients with constipation\u2010predominant irritable bowel syndrome (IBS\u2010C) using data from a completed trial (NCT01880424).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this phase III, double\u2010blind, placebo\u2010controlled trial, IBS\u2010C patients were randomized to receive linaclotide (290\u2009\u03bcg\/d) or placebo for 12\u2009weeks. Efficacy was assessed with two co\u2010primary responder end\u2010points (12\u2010wk abdominal pain\/discomfort: \u226530% reduction in either score with neither deteriorating from baseline for \u22656\u2009wks; 12\u2010wk IBS degree of relief: score\u2009\u22642 for \u2265\u20096\u2009wks), seven secondary endpoints and several additional end\u2010points.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 659 Chinese IBS\u2010C patients received linaclotide (n\u00a0=\u00a0327) or placebo (n\u00a0=\u00a0332). The 12\u2010week abdominal pain\/discomfort end\u2010point was met in 62.1% and 53.3% of the linaclotide\u2010treated and placebo\u2010treated patients, respectively (odds ratio [OR] 1.43, 95% confidence interval [CI] 1.05\u20101.96, <jats:italic>P<\/jats:italic>\u00a0=\u00a00.023); the 12\u2010week IBS degree of relief end\u2010point was achieved in 32.7% and 16.9% of the patients treated with linaclotide and placebo, respectively (OR 2.40, 95% CI 1.66\u20103.47, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). The linaclotide\u2010treated patients had a shorter time to the first spontaneous bowel movement than the placebo\u2010treated patients (23.6\u2009h vs 43.7\u2009h, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). Linaclotide produced significantly greater improvement than placebo in all secondary end\u2010points from the first 2\u2009weeks (all <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). Diarrhea was reported in 8.3% of linaclotide\u2010treated patients and 1.2% of placebo\u2010treated patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Linaclotide (290\u2009\u03bcg\/d) was efficacious and well\u2010tolerated in Chinese IBS\u2010C patients with a rapid onset of effect.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1751-2980.13081","type":"journal-article","created":{"date-parts":[[2022,1,12]],"date-time":"2022-01-12T12:38:19Z","timestamp":1641991099000},"page":"99-110","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub\u2010cohort analysis of a phase <scp>III<\/scp>, randomized, double\u2010blind, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"23","author":[{"given":"Li Hua","family":"Peng","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology, The First Medical Center Chinese PLA General Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing Yuan","family":"Fang","sequence":"additional","affiliation":[{"name":"State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology &amp; Hepatology, Ministry of Health, Division of Gastroenterology and Hepatology Shanghai Cancer Institute, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ning","family":"Dai","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Sir Run Run Shaw Hospital Zhejiang University School of Medicine  Hangzhou Zhejiang Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xi Zhong","family":"Shen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Zhongshan Hospital, Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"You Lin","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology The First Affiliated Hospital of Harbin Medical University  Harbin Heilongjiang Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Ruijin Hospital, Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun Sheng","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, The First Medical Center Chinese PLA General Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,3,3]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2016.14"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(19)30199-2"},{"issue":"12","key":"e_1_2_8_5_1","first-page":"803","article-title":"Study Group of Functional Gastrointestinal Disorders, Study Group of Gastrointestinal Motility, Chinese Society of Gastroenterology, Chinese Medical Association. 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