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Renzapride Improves Symptoms in Constipation-Predominant Irritable Bowel Syndrome: Presented at UEGW
By Adrian Burton
MADRID, SPAIN -- November 4, 2003 -- Renzapride, a new 5-HT4 agonist/5-HT3 antagonist, relieves the symptoms of constipation-predominant irritable bowel syndrome (C-IBS), increasing bowel movement frequency and softening stools.
Dr. Nicholas Meyers, Development Manager for Alizyme Therapeutics Ltd, Cambridgeshire, United Kingdom, reported the results here November 3rd at the 11th United European Gastroenterology Week.
Irritable bowel syndrome is a common disease, the symptoms of which may include constipation, diarrhoea or both. "There really are no suitable treatments for irritable bowel syndrome [in Europe]," explained Dr. Meyers. "By and large, the sort of treatments people can buy over the counter such as peppermint oil don't really work. So we need more active drugs."
In this large, placebo controlled, double blind Phase IIb trial that enrolled 510 patients with C-IBS, 125 received 1 mg of renzapride, 125 other patients received 2 mg of the drug, and 135 received 4 mg of renzapride, while 125 received placebo. Treatment was dosed every day for 12 weeks.
Patients kept diaries to record their perceived response to treatment in terms of pain or discomfort relief, and recorded their frequency of bowel movements and the consistency of their stools.
The 4-mg/day dose significantly increased the frequency of bowel movements from a mean of 0.9 to 1.7 in Week 1, decreasing after that time, but remaining significant during Weeks 1 through 4 (P < .0001) and through to the end of the study (P < .0046). The same dose also improved stool softness (from a baseline of 0.2 on an arbitrary softness scale to over 0.5 in Weeks 1 through 4 (P < .0048), and to just under 0.5 during weeks 5-12 (P < .016).
When analysed alone, the female population showed slightly better results.
Adverse events at the effective 4-mg/day dose were diarrhoea in 25.2% of patients and headache in 17.8%. The rate of serious adverse events was 1.6% for all patients taking renzapride compared to 2.4% for those taking placebo.
"We hope to be reporting the effects of renzapride in mixed-symptom patients in May [2004]," explained Dr. Meyers. "But the main message here is that [renzapride] 4 mg/day seems to work very well for C-IBS patients."
[Study title: Efficacy and Safety of Renzapride in Patients With Constipation-Predominant IBS: A Phase IIb Study in the UK Primary Healthcare Setting. Abstract Mon-G-161]
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