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 journalArticlepeer-review

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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