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Title: DG DISPATCH - ACG: Tegaserod Reduces Discomfort, Improves Bowel Function
URL: http://www.pslgroup.com/dg/13BB2E.htm
Doctor's Guide
October 20, 1999


By Andrew Bowser
Special to DG News

PHOENIX, AZ -- October 20, 1999 -- Patients with irritable bowel syndrome (IBS) marked by chronic constipation may experience relief with a drug that has pro-motile properties and a modulatory effect on visceral sensitivity. Tegaserod reduced discomfort and pain and improved bowel function in a study of 799 patients with constipation-predominant IBS. The results of this study were presented Tuesday (Oct. 19) at the American College of Gastroenterology meeting, in Phoenix, AZ

Tegaserod is a partial 5HT4 agonist, one of a class of new drugs with promise in IBS, a condition that accounts for one-quarter of all visits to gastroenterologists in the United States. "IBS has been very frustrating for patients and physicians up to now," said Dr. Martin P. Lefkowitz, Director of Clinical Research with Novartis Pharmaceuticals, East Hanover, New Jersey, USA. "Hopefully this is the beginning of a new era in treating the underlying pathophysiology of the condition."

In this study, the patients were randomized to 12 weeks of either tegaserod (doses of 4 mg and 12 mg) or placebo, preceded by a four-week period in which baseline symptoms and bowel movements were recorded. Patients treated with tegaserod at both dosage levels had an increased number of bowel movements (p < 0.01 versus placebo), an effect which was sustained over the three-month treatment period.

The tegaserod-treated patients also had fewer days of abdominal pain and other IBS symptoms. In the third month of treatment, patients treated with 12 mg tegaserod reported a 20 percent decrease from baseline in the number of days with significant abdominal discomfort and pain. Additionally, tegaserod was well-tolerated, with about 10 percent of patients experiencing diarrhea (generally in the first week or two of treatment) versus 3 percent in the placebo group.

Tegaserod, which has cleared Phase III trials, isn't the only agent in this class with promise for constipation-predominant IBS patients; today (Oct. 20), researchers will present positive findings from two randomized, placebo-controlled, double-blind trials of prucalopride, a 5HT4 agonist from Janssen Pharmaceuticals.

Related Link: Janssen Pharmaceuticals.

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