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Nails in the coffin for renzapride
▶ Lembo AJ, Cremonini F, Meyers N, et al. Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation – a double-blind, randomized, placebo-controlled, study. Aliment Pharmacol Ther. PubMed PMID: 20163375. Published Online First: 16 February 2010.
Since the withdrawal of tegaserod, due to safety concerns, the treatment options for constipation-predominant irritable bowel syndrome (IBS-C) remain limited. The US Food and Drug Administration agency approved the use of lubiprostone for the condition recently, following the results of two randomised controlled trials (RCTs). Lembo et al, report results from a large RCT using renzapride, a partial 5-HT3 antagonist and 5-HT4 agonist, in female patients with IBS-C.
Patients with Rome II IBS-C were randomized in a double-blind trial to receive treatment with renzapride 4 mg once daily, 2 mg twice daily, or placebo for 12 weeks. Response to therapy was assessed using patient-reported adequate relief of global IBS symptoms. There was a significant benefit of renzapride therapy over placebo, in terms of the mean number of months patients were classed as a responder to therapy (0.55 with renzapride 4 mg daily and 0.60 with 2 mg twice daily, vs 0.44 with placebo, p=0.03 and …
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