title: Efficacy and Safety of Prucalopride in Chronic Constipation: An Integrated Analysis of Six Randomized, Controlled Clinical Trials.
abstract: Prucalopride, a selective, high-affinity 5-hydroxytryptamine 4 receptor agonist, stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation (CC) in adults. The relative efficacy by gender has not been evaluated.
  
  
  
  To evaluate the global efficacy and safety of prucalopride 2 mg daily in men and women with CC using data from six large, randomized, controlled clinical trials.
  
  
  
  Data were combined from six phase 3 and 4, double-blind, randomized, placebo-controlled, parallel-group trials. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week over 12 weeks of treatment. Safety was assessed throughout all the trials.
  
  
  
  Overall, 2484 patients (597 men; 1887 women; prucalopride, 1237; placebo, 1247) were included in the integrated efficacy analysis and 2552 patients were included in the integrated safety analysis. Significantly more patients achieved a mean of ≥3 SCBMs/week over the 12 weeks of treatment in the prucalopride group (27.8 %) than in the placebo group [13.2 %, OR 2.68 (95 % CI 2.16, 3.33), p < 0.001]. Prucalopride had a favorable safety and tolerability profile. Efficacy and safety outcomes were not significantly different between men and women.
  
  
  
  The integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.
authors.affiliation: C.E.N.T.E.R., Mayo Clinic College of Medicine, Charlton 8-110, 200 First St. S.W., Rochester, MN, 55905, USA. camilleri.michael@mayo.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Camilleri
authors.affiliation: Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Hubert
authors.initials: H
authors.lastname: Piessevaux
authors.affiliation: County Durham and Darlington NHS Foundation Trust, Durham, UK.
authors.forename: Yan
authors.initials: Y
authors.lastname: Yiannakou
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: Orion Statistical Consulting BV, Hilvarenbeek, The Netherlands.
authors.forename: René
authors.initials: R
authors.lastname: Kerstens
authors.affiliation: Division of Gastroenterology and Hepatology, Lynda K and David M Underwood Center for Digestive Disorders, Houston Methodist Hospital and Weill Cornell Medical College, Houston, TX, USA.
authors.forename: Eamonn M M
authors.initials: EMM
authors.lastname: Quigley
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: Shire, Brussels, Belgium.
authors.forename: Susana
authors.initials: S
authors.lastname: Da Silva
authors.affiliation: Shire, Wayne, PA, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Levine
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001572:Benzofurans / Q000627:therapeutic use*; D002908:Chronic Disease; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D058828:Serotonin 5-HT4 Receptor Agonists / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001572:Benzofurans; D058828:Serotonin 5-HT4 Receptor Agonists; C406662:prucalopride
keywords: Constipation; Efficacy; Prucalopride; Safety