Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation--a 12-week, randomized, double-blind, placebo-controlled study.

Abstract:

BACKGROUND:Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL). AIM:A randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy and safety of a selective, high-affinity 5-HT(4) receptor agonist, prucalopride, in patients with chronic constipation [or=3 SCBMs/week, averaged over 12 weeks. Other assessments included BM frequency, constipation-related QoL and symptoms and tolerability. RESULTS:Among 641 patients, significantly more patients taking prucalopride 2 or 4 mg (24%) than placebo (12%), achieved the primary efficacy endpoint (>or=3 SCBMs/week) or an increase of >or=1 SCBMs/week; 43% and 47% vs. 28% respectively. Prucalopride-treated patients also achieved significantly greater satisfaction with treatment and bowel function, and improved perception of constipation severity and constipation-related QoL, compared with placebo. Most frequent treatment-related adverse events were headache, abdominal pain, nausea and diarrhoea (mainly during day 1). There were no differences in comparison to placebo in the incidence of serious adverse effects or cardiovascular events. CONCLUSION:Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation.

journal_name

Aliment Pharmacol Ther

authors

Quigley EM,Vandeplassche L,Kerstens R,Ausma J

doi

10.1111/j.1365-2036.2008.03884.x

subject

Has Abstract

pub_date

2009-02-01 00:00:00

pages

315-28

issue

3

eissn

0269-2813

issn

1365-2036

pii

APT3884

journal_volume

29

pub_type

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