{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T23:35:51Z","timestamp":1767828951261,"version":"3.49.0"},"reference-count":41,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,10,6]],"date-time":"2024-10-06T00:00:00Z","timestamp":1728172800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004948","name":"Astellas Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004948","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>This study aimed to evaluate the efficacy and safety of linaclotide in patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS\u2010C) who did not respond to treatment with magnesium oxide (MgO).<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<jats:bold>s<\/jats:bold><\/jats:title><jats:p>This study was designed as a multicenter, open\u2010label, single\u2010arm, exploratory study. Patients with CC or IBS\u2010C who took MgO and those meeting the medication initiation criteria were administered linaclotide at a daily dosage of 500\u2009\u03bcg for 12\u2009weeks. The primary endpoint was a change in the Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC\u2010QOL) score from baseline, which was evaluated by using a paired <jats:italic>t<\/jats:italic>\u2010test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Key Results<\/jats:title><jats:p>The patients' mean age (\u00b1 standard deviation) was 67.6\u2009\u00b1\u200913.82\u2009years. The full analysis set included 61 patients. The JPAC\u2010QOL total score was 1.60 at baseline and 0.70 at 12\u2009weeks, with a significant mean change of \u22120.89\u2009\u00b1\u20090.721 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Several secondary endpoints also showed improvement. The frequency of spontaneous bowel movement (SBM) and complete SBM increased by 2.70\u2009\u00b1\u20097.254 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01) and 2.81\u2009\u00b1\u20095.254 times, respectively (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). The Bristol Stool Form Scale, abdominal bloating severity, and straining severity scores improved by 1.33\u2009\u00b1\u20091.274 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), \u22120.16\u2009\u00b1\u20090.563 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05), and \u22120.46\u2009\u00b1\u20090.795 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) points, respectively. The safety analysis set included 65 patients, 7 of whom had diarrhea, which improved with dose reduction and drug withdrawal.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion &amp; Inferences<\/jats:title><jats:p>The study was conducted in an older adult population, similar to real clinical practice. Linaclotide may be an option for treating CC that shows an inadequate response to conventional therapy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/nmo.14938","type":"journal-article","created":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T04:44:24Z","timestamp":1728276264000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of linaclotide in treatment\u2010resistant chronic constipation: A multicenter, open\u2010label study"],"prefix":"10.1111","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5150-7942","authenticated-orcid":false,"given":"Tsutomu","family":"Yoshihara","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"},{"name":"Department of Internal Medicine Kanagawa Dental University Yokohama Clinic  Yokohama Kanagawa Japan"},{"name":"Department of Internal Medicine NamikiKoiso\u2010medical Clinic  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takaomi","family":"Kessoku","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"},{"name":"Department of Internal Medicine Kanagawa Dental University Yokohama Clinic  Yokohama Kanagawa Japan"},{"name":"Department of Internal Medicine NamikiKoiso\u2010medical Clinic  Yokohama Kanagawa Japan"},{"name":"Department of Palliative Medicine Yokohama City University Hospital  Yokohama Kanagawa Japan"},{"name":"Department of Palliative Medicine International University of Health and Welfare Narita Hospital  Narita Chiba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomohiro","family":"Takatsu","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noboru","family":"Misawa","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keiichi","family":"Ashikari","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiko","family":"Fuyuki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"},{"name":"Department of Palliative Medicine Yokohama City University Hospital  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hidenori","family":"Ohkubo","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takuma","family":"Higurashi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michihiro","family":"Iwaki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Yokohama City University School of Medicine  Yokohama Kanagawa Japan"},{"name":"Department of Internal Medicine Kanagawa Dental University Yokohama Clinic  Yokohama Kanagawa Japan"},{"name":"Department of Palliative Medicine Yokohama City University Hospital  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeo","family":"Kurihashi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Kanagawa Dental University Yokohama Clinic  Yokohama Kanagawa Japan"},{"name":"Department of Primary Care and General Medicine Tokyo Medical University  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Machiko","family":"Nakatogawa","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine NamikiKoiso\u2010medical Clinic  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Data Science Yokohama City University School of Medicine  Yokohama Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Izuru","family":"Terada","sequence":"additional","affiliation":[{"name":"Operational Excellence, Medical Affairs Astellas Pharma Inc.  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