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Dig Dis Sci. 2016 Aug;61(8):2357-72. doi: 10.1007/s10620-016-4147-9. Epub 2016 Apr 7.

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

Author information

1
C.E.N.T.E.R., Mayo Clinic College of Medicine, Charlton 8-110, 200 First St. S.W., Rochester, MN, 55905, USA. camilleri.michael@mayo.edu.
2
Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
3
County Durham and Darlington NHS Foundation Trust, Durham, UK.
4
Translational Research Center for Gastrointestinal Disorders TARGID, University of Leuven, Leuven, Belgium.
5
Orion Statistical Consulting BV, Hilvarenbeek, The Netherlands.
6
Division of Gastroenterology and Hepatology, Lynda K and David M Underwood Center for Digestive Disorders, Houston Methodist Hospital and Weill Cornell Medical College, Houston, TX, USA.
7
Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China.
8
Shire, Brussels, Belgium.
9
Shire, Wayne, PA, USA.

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.

KEYWORDS:

Constipation; Efficacy; Prucalopride; Safety

PMID:
27056037
PMCID:
PMC4943977
DOI:
10.1007/s10620-016-4147-9
[Indexed for MEDLINE]
Free PMC Article

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