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Title: Tegaserod First Drug Effective for Women With Irritable Bowel Syndrome and "Mixed" Symptoms: Presented at DDW

"Tegaserod First Drug Effective for Women With Irritable Bowel Syndrome and "Mixed" Symptoms: Presented at DDW"

By Bruce Sylvester LOS ANGELES, C.A. -- May 23, 2006 -- Tegaserod (Zelnorm) is effective and safe for the treatment of irritable bowel syndrome (IBS) in women with a mixed/alternating (constipation/diarrhea) bowel habit, researchers reported here at Digestive Diseases Week 2006 (DDW). This study is the first to indicate a potentially effective treatment for patients with IBS and a mixed bowel pattern, noted the presenter and lead investigator William Chey, MD, associate professor of medicine, University of Michigan Medical Center, Ann Arbor, Michigan. "When people seek treatment for IBS, they are classified as having either IBS with constipation or IBS with diarrhea," explained Dr. Chey. "But then there is this other group that doesn't fit into either one of those categories. They either have a combination of diarrhea or constipation during the week or they alternate between longer periods of the 2 conditions. This is a substantial group -- 30% to 40% of IBS patients." Dr. Chey noted that no current therapies have been rigorously tested for these mixed-symptom patients. "There are data showing significant movement between the IBS-with-constipation (IBS-C) group and the IBS-with-mixed-symptoms (IBS-M) group. So it made sense to study tegaserod, which works for IBS-C patients." Dr. Chey and his team of researchers randomized 661 women (IBS-C, 337 and IBS-M, 324) to 4 weeks of treatment with tegaserod 6 mg twice daily or placebo. The team reported that tegaserod provided statistically significant improvement in satisfactory relief of IBS symptoms over the 4-week treatment period for both the IBS-C and IBS-M groups. For both groups, the percentage of patients experiencing satisfactory relief of IBS symptoms (considered 3 out of 4 weeks of treatment) was significantly higher for tegaserod compared with placebo. Tegaserod was also significantly better than placebo at improving weekly bowel-movement frequency, stool consistency, and days per week with straining. "The main finding was that tegaserod at 6 mg taken twice daily was effective both in women with IBS-C and in women with IBS-M," said Dr. Chey. "This is the first well-designed, large study that has shown these beneficial results for the mixed-symptom group." Tegaserod is indicated for the short-term treatment of women with IBS whose primary bowel symptom is constipation. Tegaserod is also indicated for the treatment of male and female patients less than 65 years of age with chronic idiopathic constipation. This study was supported by Novartis Pharmaceuticals, East Hanover, New Jersey. [[Presentation title: Tegaserod Improves Multiple Symptoms in Women With Mixed/alternating Bowel Habits as Well as Those With IBS-C. Abstract 135]

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