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

Dig Dis Sci. 2016 Aug;61(8):2357-2372. doi: 10.1007/s10620-016-4147-9. Epub 2016 Apr 7.


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.

Keywords: Constipation; Efficacy; Prucalopride; Safety.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Benzofurans / therapeutic use*
  • Chronic Disease
  • Clinical Trials, Phase III as Topic
  • Clinical Trials, Phase IV as Topic
  • Constipation / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Serotonin 5-HT4 Receptor Agonists / therapeutic use*
  • Treatment Outcome
  • Young Adult


  • Benzofurans
  • Serotonin 5-HT4 Receptor Agonists
  • prucalopride