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Title: Tegaserod Rapidly Effective in Patients With Constipation-Predominant Irritable Bowel Syndrome: Presented at UEGW

"Tegaserod Rapidly Effective in Patients With Constipation-Predominant Irritable Bowel Syndrome: Presented at UEGW"

By Adrian Burton MADRID, SPAIN -- November 4, 2003 -- Tegaserod provides almost immediate symptomatic relief for patients with constipation-predominant irritable bowel syndrome (C-IBS), report Researchers from Baltimore, Maryland, United States at the United European Gastroenterology Week . "Irritable bowel syndrome is one of the most common disorders in the world," explained James Novick, MD, principal investigator, Charm City Research, a group of primary care gastroenterologists involved in clinical trials. "Till this time there has been no one good therapy that will address the symptoms of [this problem] such as abdominal pain, bloating and constipation, diarrhoea or [alternating constipation diarrhoea]." In their study, the researchers analysed the results of three randomised, multicentre trials involving the use of tegaserod for treatment of C-IBS. The total number of C-IBS patients in the pooled data was 2,472 women. The trials were performed in women since significantly fewer men are affected by the condition. The researchers randomised 1,245 women to receive tegaserod 6 mg twice per day and 1,227 to placebo. After 1 week of treatment, symptoms were assessed using the subjects' global assessment (SGA) of relief score. Daily bloating and stool consistency scores (7-point scales) and the number of bowel movements (BM) were monitored and changes from baseline calculated. After 1 week of treatment there were no significant changes in the placebo group scores for SGA of relief, abdominal pain/discomfort, bloating, number of BMs or stool consistency. In the tegaserod group, however, the number of BMs improved from Day 1, increasing from a mean baseline score of 0.67 to 1. 3 BMs/day. "One of the things we observe [is that] when people respond -- and they respond in the majority of cases -- they do so quite rapidly," explained Dr. Novick. Further, the SGA of relief score in treated patients showed a 58% improvement over baseline (P < .0001). Significant reductions in bloating, and stool consistency were also apparent (P < .0001). "[These results show that] people taking tegaserod do, in fact feel a lot better - and rapidly," explained Dr. Novick. "Healthy [women] can also complain of bloating during their menstrual cycle. Most women would not require any treatment for this, but some women are plagued by it and [we might speculate] that they might also benefit from short term use of medications such as this." [Study title: Tegaserod is Immediately Effective After Start of Treatment in Patients With Constipation Predominant Irritable Bowel Syndrome (IBSC). Abstract Mon-G-172]

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