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Title: Effect of prucalopride in the treatment of chronic constipation in Asian and non-Asian women: A pooled analysis of 4 randomized, placebo-controlled studies
Authors: Mei Yun Ke
Jan Tack
Eamonn M.M. Quigley
Duowu Zou
Suck Chei Choi
Somchai Leelakusolvong
Andy Liu
Jin Yong Kim
Peking Union Medical College
KU Leuven
Methodist Hospital Houston
Second Military Medical University
Wonkwang University
Mahidol University
Janssen Research and Development
Janssen Asia-Pacific
Keywords: Medicine
Issue Date: 1-Jan-2014
Citation: Journal of Neurogastroenterology and Motility. Vol.20, No.4 (2014), 458-468
Abstract: © 2014 The Korean Society of Neurogastroenterology and Motility. Background/Aims: To compare the efficacy and safety of prucalopride, a novel selective high-affinity 5-hydroxytryptamine type 4 receptor agonist, versus placebo, in Asian and non-Asian women with chronic constipation (CC). Methods: Data of patients with CC, receiving once-daily prucalopride 2-mg or placebo for 12-weeks, were pooled from 4 double-blind, randomized, phase-III trials (NCT00488137, NCT00483886, NCT00485940 and NCT01116206). The efficacy endpoints were: average of ≥ 3 spontaneous complete bowel movements (SCBMs)/week; average increases of ≥ 1 SCBMs/week; and change from baseline in each CC-associated symptom scores (bloating, abdominal pain, hard stool and straining). Results: Overall, 1,596 women (Asian [26.6%], non-Asian [73.4%]) were included in this analysis. Significantly more patients in the prucalopride group versus placebo experienced an average of ≥ 3 SCBMs/week in Asian (34% vs. 11%, P < 0.001) and non-Asian (24.6% vs. 10.6%, P < 0.001) subgroups. The number of patients reporting an increase of ≥ 1 SCBMs/week from baseline was significantly higher in the prucalopride group versus placebo among both Asian (57.4% vs. 28.3%, P < 0.001) and non-Asian (45.3% vs. 24.0%, P < 0.001) subgroups. The difference between the subgroups was not statistically significant. Prucalopride significantly reduced the symptom scores for bloating, hard stool, and straining in both subgroups. Conclusions: Prucalopride 2-mg once-daily treatment over 12-weeks was more efficacious than placebo in promoting SCBMs and improvement of CC-associated symptoms in Asian and non-Asian women, and was found to be safe and well-tolerated. There were numeric differences between Asian and non-Asian patients on efficacy and treatment emergent adverse events, which may be partially due to the overlap with functional gastrointestinal disorders in non-Asian patients.
ISSN: 20930887
Appears in Collections:Scopus 2011-2015

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