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

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.

• Authors: Michael Camilleri, Hubert Piessevaux, Yan Yiannakou, Jan Tack, René Kerstens, Eamonn M M Quigley, MeiYun Ke, Susana Da Silva, Amy Levine
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 61 Issue 8 Pg. 2357-2372 (08 2016) ISSN: 1573-2568 [Electronic] United States
• PMID: 27056037 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Benzofurans
• Serotonin 5-HT4 Receptor Agonists
• prucalopride

Topics

• 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