Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation - a double-blind, randomized, placebo-controlled, study.

Abstract

BACKGROUND:

Renzapride, a 5-hydroxytryptamine type-4 (5-HT(4)) receptor agonist and 5-HT(3) receptor antagonist, has been proposed as a new treatment of irritable bowel syndrome with constipation (IBS-C).

AIM:

To assess the efficacy and safety of renzapride in women with IBS-C.

METHODS:

Women with IBS-C were randomized to renzapride 4 mg daily, 2 mg b.d. or placebo for 12 weeks. The primary outcome measure was global relief of IBS symptoms. A subset of patients were enrolled in a 12-month, open-label study of renzapride 4 mg daily.

RESULTS:

A total of 1798 patients were included in the efficacy analysis and 971 patients entered the long-term study. The mean (S.E.M.) number of months with relief of overall IBS symptoms was 0.55 (0.04), 0.60 (0.04) and 0.44 (0.04) in the renzapride 4 mg daily, 2 mg b.d. and placebo groups (P = 0.027 and P = 0.004 respectively). Small yet statistically significant differences in favour of renzapride were observed on stool consistency and frequency, and bloating/abdominal distension scores. Renzapride was generally well tolerated; however, three episodes of ischaemic colitis were reported in the long-term study.

CONCLUSION:

Given the limited increase in efficacy over placebo and the incidence of ischaemic colitis observed, our data suggest that the benefit/risk ratio of renzapride is not sufficient to warrant further study in IBS-C.

• Authors: A J Lembo, F Cremonini, N Meyers, R Hickling
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 31 Issue 9 Pg. 979-90 (May 2010) ISSN: 1365-2036 [Electronic] England
• PMID: 20163375 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Benzamides
• Bridged Bicyclo Compounds, Heterocyclic
• Gastrointestinal Agents
• Serotonin Antagonists
• renzapride

Topics

• Adolescent
• Adult
• Aged
• Benzamides (administration & dosage)
• Bridged Bicyclo Compounds, Heterocyclic (administration & dosage)
• Constipation (drug therapy)
• Double-Blind Method
• Female
• Gastrointestinal Agents (therapeutic use)
• Humans
• Irritable Bowel Syndrome (drug therapy)
• Middle Aged
• Quality of Life
• Serotonin Antagonists (therapeutic use)
• Treatment Outcome
• Young Adult