Efficacy and Safety of Prucalopride in Chronic Constipation: An Integrated Analysis of Six Randomized, Controlled Clinical Trials

Michael Camilleri, Hubert Piessevaux, Yan Yiannakou, Jan Tack, René Kerstens, Eamonn M M Quigley, Mei Yun Ke, Susana da Silva, Amy Levine

Research output: Contribution to journalArticle

36 Scopus citations

Abstract

Background: 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. Aim: 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. Methods: 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. Results: 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. Conclusion: The integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.

Original languageEnglish (US)
Pages (from-to)2357-2372
Number of pages16
JournalDigestive Diseases and Sciences
Volume61
Issue number8
DOIs
StatePublished - Aug 1 2016

Keywords

  • Constipation
  • Efficacy
  • Prucalopride
  • Safety

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

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