Authors: Michael Camilleri Hubert Piessevaux Yan Yiannakou Jan Tack René Kerstens Eamonn M M Quigley MeiYun Ke Susana Da Silva Amy Levine
Publish Date: 2016/04/07
Volume: 61, Issue: 8, Pages: 2357-2372
Abstract
Prucalopride a selective highaffinity 5hydroxytryptamine 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 evaluatedData were combined from six phase 3 and 4 doubleblind randomized placebocontrolled parallelgroup 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 trialsOverall 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 278 than in the placebo group 132 OR 268 95 CI 216 333 p 0001 Prucalopride had a favorable safety and tolerability profile Efficacy and safety outcomes were not significantly different between men and women
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