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Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation – a double‐blind, randomized, placebo‐controlled, study
Author(s) -
LEMBO A. J.,
CREMONINI F.,
MEYERS N.,
HICKLING R.
Publication year - 2010
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2010.04265.x
Subject(s) - irritable bowel syndrome , medicine , constipation , placebo , double blind , gastroenterology , randomized controlled trial , clinical trial , lubiprostone , chronic constipation , alternative medicine , pathology
Aliment Pharmacol Ther 31 , 979–990 Summary 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.