SAN FRANCISCO, CA — May 23, 2002 —
A meta-analysis of four placebo-controlled phase III trials of tegaserod involving more than 4,000 patients found the drug to be safe and effective treatment for irritable bowel syndrome (IBS) patients with constipation.
The meta-analysis, which was presented at Digested Disease Week (DDW) in San Francisco, included unpublished data from the drug manufacturer, Novartis.
Tegaserod produced global IBS symptom relief more frequently than placebo, with a relative risk of 1.16. A sub-group analysis limited to patients using tegaserod 6 mg bid demonstrated greater global IBS symptom relief; the relative risk in that group was 1.25. Tegaserod was more likely than placebo to produce global relief of abdominal discomfort, with a relative risk of 1.21.
There was no significant difference in total adverse events. Diarrhea was more common among patients using tegaserod, with a relative risk of 2.15. “What people have to understand is it’s a collection of symptoms with different causes in different patients,” said co-author Dr. William D. Chey, director of the GI Physiology Laboratory, the University of Michigan Health System, Ann Arbor.
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