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Title: Tegaserod Effective in Long-Term Use for Chronic Constipation: Presented at DDW

"Tegaserod Effective in Long-Term Use for Chronic Constipation: Presented at DDW"

By Bruce Sylvester LOS ANGELES, C.A. -- May 25, 2006 -- Most patients who respond to tegaserod (Zelnorm®) after 4 weeks of therapy for chronic constipation and who continue on the drug will show long-term improvements of the condition, researchers reported here at Digestive Diseases Week 2006 (DDW). "These results are encouraging," said presenter and investigator Lin Chang, associate professor of medicine, University of California, Los Angeles, California, in a presentation on May 23[^rd. "And they indicate that the great majority of patients who respond to 4 weeks of tegaserod treatment will get derive ongoing benefit from this treatment for the symptoms of chronic constipation. "

In this blinded extension study, the investigators used a 5-point Likert scale to perform monthly assessments of symptoms of constipation -- abdominal distension/bloating, abdominal pain/discomfort, bothersomeness of constipation, and satisfaction with bowel habits.

Responders to tegaserod 6 mg BID pre-extension trial who continued to use the drug in the extension were included in this analysis.

Response in the pre-extension period (12 weeks prior to the 13 month extension) was an average improvement of at least 1 complete spontaneous bowel movement per week during the first 4 weeks of therapy. Response at 12 weeks was defined in the same way.

Response in the extension period was defined as a reduction of the average symptom severity over month 1 to month 13 compared with baseline of at least 0.5 points for at least 50% of reported symptom scores.

The investigators reported that 41% of the 278 patients who took 6 mg BID in the extension were 4-week responders in the core trial, and that 88% of 113 of these 4-week responders were still in this category at the end of the 12-week core trial period.

During the 13 months of the extension phase, 85% of 107 of these 12-week responders continued to respond to treatment (6 of the 113 excluded due to unavailable data).

Using the 5-point Likert scale, the researchers reported that average severity reductions were 0.93 for abdominal distension/bloating, 0.88 for abdominal pain/discomfort, 1.13 for bothersomeness of constipation, and 1.36 for satisfaction with bowel habits. All improvements were statistically significant and clinically meaningful (at least 0.5-point improvement on a 5-point scale)

According to the researchers, "85% of patients who initially respond to tegaserod will continue to respond and this clinical response averaged 1-point improvement in a 5-point Likert scale over more than 1 year follow-up."

"These results clearly demonstrate that the vast majority of patients who respond to tegaserod after 4 weeks of therapy will manifest long-term improvement in the multiple symptoms of chronic constipation," they concluded.

The study was supported by Novartis Pharmaceuticals.

[Presentation title: Tegaserod Is Effective for Long-Term Use in Patients With Chronic Constipation. Poster T2039]

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