{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T11:05:06Z","timestamp":1784199906086,"version":"3.55.0"},"reference-count":42,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> Prucalopride (1 or 2\u2009mg once daily) is approved for treating adults with chronic idiopathic constipation (CIC). <\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives:<\/jats:title><jats:p> We determined the effect of age, body mass index (BMI), and renal function on the efficacy and safety of prucalopride in adults with CIC. <\/jats:p><\/jats:sec><jats:sec><jats:title>Design:<\/jats:title><jats:p> Data were pooled from six 12-week, phase III\u2013IV clinical studies in adults who received prucalopride (1 or 2\u2009mg once daily) or placebo for CIC. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Adults were stratified by age (&lt;50; 50\u201364; \u2a7e65\u2009years), BMI (underweight\/healthy weight, &lt;25\u2009kg\/m<jats:sup>2<\/jats:sup>; overweight, 25 to &lt;30\u2009kg\/m<jats:sup>2<\/jats:sup>; obese, \u2a7e30\u2009kg\/m<jats:sup>2<\/jats:sup>), and renal function (normal renal function, estimated glomerular filtration rate (eGFR) \u2a7e90\u2009mL\/min\/1.73\u2009m<jats:sup>2<\/jats:sup>; mild renal impairment, eGFR 60 to &lt;90\u2009mL\/min\/1.73\u2009m<jats:sup>2<\/jats:sup>; moderate renal impairment, eGFR 30 to &lt;60\u2009mL\/min\/1.73\u2009m<jats:sup>2<\/jats:sup>). The primary efficacy endpoint was the proportion of patients with a mean of \u2a7e3 complete spontaneous bowel movements\/week over 12\u2009weeks. Safety data were evaluated descriptively. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> Of 2484 patients stratified by age (prucalopride, n\u2009=\u20091237; placebo, n\u2009=\u20091247), 1402, 708, and 374 were aged &lt;50, 50\u201364, and \u2a7e65\u2009years, respectively. Of 2482 patients stratified by BMI (prucalopride, n\u2009=\u20091237; placebo, n\u2009=\u20091245), 1425, 713, and 344 were underweight\/healthy weight, overweight, and obese, respectively. Of 2474 patients stratified by renal function (prucalopride, n\u2009=\u20091233; placebo, n\u2009=\u20091241), 1444, 869, and 161 had normal renal function, mild renal impairment, and moderate renal impairment, respectively. More prucalopride-treated than placebo-treated patients achieved the primary efficacy endpoint. The difference was significant for all subgroups, except for the obese and moderate renal impairment subgroups. More prucalopride-treated than placebo-treated patients reported treatment-related adverse events in most subgroups. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> Prucalopride demonstrated efficacy in adults with CIC, irrespective of age, BMI, and renal function. No unexpected safety concerns were identified. <\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration:<\/jats:title><jats:p> ClinicalTrials.gov identifiers ( https:\/\/clinicaltrials.gov\/ ): NCT01147926, NCT01424228, NCT01116206, NCT00483886, NCT00485940, NCT00488137. <\/jats:p><\/jats:sec>","DOI":"10.1177\/17562848241299731","type":"journal-article","created":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T13:43:13Z","timestamp":1733838193000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies"],"prefix":"10.1177","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4479-1188","authenticated-orcid":false,"given":"Anthony","family":"Lembo","sequence":"first","affiliation":[{"name":"Digestive Disease Institute, Cleveland Clinic, Main Campus, 9500 Euclid Avenue, Cleveland, OH 44195, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4925-4290","authenticated-orcid":false,"given":"Kyle","family":"Staller","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mena","family":"Boules","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7643-9576","authenticated-orcid":false,"given":"Paul","family":"Feuerstadt","sequence":"additional","affiliation":[{"name":"PACT Gastroenterology Center, Hamden, CT, USA Yale University School of Medicine, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Spalding","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Lexington, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andr\u00e9","family":"Gabriel","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashraf","family":"Youssef","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunlong","family":"Xie","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Terreri","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brooks D.","family":"Cash","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology, and Nutrition, University of Texas Health Science Center at Houston, Houston, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,12,10]]},"reference":[{"key":"bibr1-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.164"},{"key":"bibr2-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"bibr3-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2008.04.016"},{"key":"bibr4-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2004.30887.x"},{"key":"bibr5-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-021-01806-5"},{"key":"bibr6-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15500"},{"key":"bibr7-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2005.40885.x"},{"key":"bibr8-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1186\/s12889-022-14360-w"},{"key":"bibr9-17562848241299731","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2023.115281"},{"key":"bibr10-17562848241299731","unstructured":"World Health Organisation. 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