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.
abstract: OBJECTIVE
  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 improve-ment 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.(J Neurogastroenterol Motil 2014;20:458-468).
authors.affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China.
authors.forename: MeiYun
authors.initials: M
authors.lastname: Ke
authors.affiliation: Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Tack
authors.affiliation: Houston Methodist Hospital and Weill Cornell Medical College, Houston, Texas, USA.
authors.forename: Eamonn M M
authors.initials: EM
authors.lastname: Quigley
authors.affiliation: Second Military Medical University, Shanghai, China.
authors.forename: Duowu
authors.initials: D
authors.lastname: Zou
authors.affiliation: Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
authors.forename: Suck Chei
authors.initials: SC
authors.lastname: Choi
authors.affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Somchai
authors.initials: S
authors.lastname: Leelakusolvong
authors.affiliation: Janssen Research and Development, Shanghai, China.
authors.forename: Andy
authors.initials: A
authors.lastname: Liu
authors.affiliation: Janssen Asia-Pacific, Singapore.
authors.forename: JinYong
authors.initials: J
authors.lastname: Kim
keywords: Asian women; Chronic constipation; Non-Asian women; Prucalopride; Serotonin 5-HT4 receptor agonists