Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation - a double-blind, randomized, placebo-controlled, study.
Aliment Pharmacol Ther. 2010 Feb 16;
Authors: Lembo AJ, Cremonini F, Meyers N, Hickling R
Background: Renzapride, a 5-HT(4) receptor agonist and 5-HT(3) receptor antagonist has been proposed as a new treatment of IBS-C. Aim: To assess the efficacy and safety of renzapride in IBS-C. Methods: Women with IBS-C were randomized to renzapride 4 mg QD, 2 mg BID, or placebo for 12 weeks. The primary outcome measure was global relief of IBS symptoms. A subset of patients enrolled in a 12-month, open-label study of renzapride 4 mg QD. Results: 1798 patients were included in the efficacy analysis and 971 patients entered the long-term study. The mean(SEM) 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 QD, 2 mg BID and placebo groups; (p=0.027 and p= 0.004, respectively). Small, yet statistically significant differences in favor of renzapride were observed on stool consistency and frequency, and bloating/abdominal distension scores. Renzapride was generally well tolerated, however, three episodes of ischemic colitis were reported in the long-term study. Conclusion: Given the limited increase in efficacy over placebo and the incidence of ischemic colitis observed, our data suggest the benefit/risk ratio of renzapride is not sufficient to warrant further study in IBS-C. Clinicaltrials.gov ID: NCT00268879.
PMID: 20163375 [PubMed - as supplied by publisher]
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