{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:30:30Z","timestamp":1753878630301,"version":"3.41.2"},"reference-count":24,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2022,8,16]],"date-time":"2022-08-16T00:00:00Z","timestamp":1660608000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Preclinical and clinical studies suggest that \u03b2<jats:sub>3<\/jats:sub>\u2010adrenergic receptor activation may be a novel target for treating abdominal pain and gastrointestinal motility dysfunction in patients with irritable bowel syndrome (IBS). This proof\u2010of\u2010concept study evaluated the efficacy and safety of the \u03b2<jats:sub>3<\/jats:sub>\u2010adrenergic agonist vibegron in treating IBS\u2010related pain.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adult women with predominant\u2010diarrhea IBS (IBS\u2010D) or with mixed diarrhea\/constipation (IBS\u2010M), diagnosed using Rome IV criteria, were randomized 1:1 to receive once\u2010daily vibegron 75\u00a0mg or placebo for 12\u00a0weeks. The primary endpoint was the percentage of patients with IBS\u2010D considered abdominal pain intensity (API) weekly responders, defined as \u226530% reduction from baseline at week 12 in mean weekly worst abdominal pain over 24\u00a0hours using the API score. Patients completed a pain diary at baseline and at weeks 2, 4, 8, and 12. Safety was assessed by adverse events (AEs) in the overall IBS population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Key Results<\/jats:title><jats:p>Of the 222 patients with IBS randomized (vibegron, <jats:italic>N<\/jats:italic>\u00a0=\u00a0111; placebo, <jats:italic>N<\/jats:italic>\u00a0=\u00a0111), 85% completed the trial. There was no significant difference in the percentage of patients with IBS\u2010D (vibegron, <jats:italic>N<\/jats:italic>\u00a0=\u00a066; placebo, <jats:italic>N<\/jats:italic>\u00a0=\u00a063) considered API weekly responders with vibegron vs. placebo (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.8222) after 12\u00a0weeks. The incidence of AEs was comparable between treatment groups (33.3% each), with equal rates of worsening IBS symptoms (2.7% each).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Inferences<\/jats:title><jats:p>In women with IBS\u2010D, vibegron was not associated with significant improvement in the percentage of API weekly responders. Vibegron was generally safe and well tolerated and, in particular, did not worsen IBS symptoms vs. placebo.<\/jats:p><\/jats:sec>","DOI":"10.1111\/nmo.14448","type":"journal-article","created":{"date-parts":[[2022,8,17]],"date-time":"2022-08-17T06:59:25Z","timestamp":1660719565000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, <scp>double\u2010blind<\/scp>, <scp>placebo\u2010controlled<\/scp> phase 2 trial"],"prefix":"10.1111","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2778-0786","authenticated-orcid":false,"given":"Brian E.","family":"Lacy","sequence":"first","affiliation":[{"name":"Gastroenterology and Hepatology Mayo Clinic  Jacksonville Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"King","sequence":"additional","affiliation":[{"name":"Urovant Sciences  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denise","family":"Shortino","sequence":"additional","affiliation":[{"name":"Urovant Sciences  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Schaumburg","sequence":"additional","affiliation":[{"name":"Urovant Sciences  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cornelia","family":"Haag\u2010Molkenteller","sequence":"additional","affiliation":[{"name":"Urovant Sciences  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William D.","family":"Chey","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology University of Michigan Health System  Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.04.014"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.061"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.0954"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41395-018-0084-x"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001036"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.12.021"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.1996.tb15294.x"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI116191"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2007.05.009"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajpgi.00051.2008"},{"key":"e_1_2_11_13_1","first-page":"131","article-title":"Randomized, double\u2010blind, placebo (PLA)\u2010controlled, crossover study to evaluate efficacy and safety of the beta 3\u2010adrenergic receptor agonist solabegron (SOL) in patients with irritable bowel syndrome (IBS)","volume":"20","author":"Kelleher DL","year":"2008","journal-title":"Neurogastroenterol Motil"},{"key":"e_1_2_11_14_1","unstructured":"BruckerBM McHaleK KingJ MuddPN.Selectivity and maximum response of vibegron and mirabegron for \u03b23\u2010adrenergic receptors. Society of Urodynamics Female Pelvic Medicine and Urogenital Reconstruction 2021 Winter Meeting; 2021 February 25\u201027; Virtual Congress"},{"volume-title":"Full Prescribing Information","year":"2020","author":"Urovant Sciences, Inc. 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