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| |  DDW: Tegaserod Safe, Well-Tolerated in Treating Constipation-Predominant Irritable Bowel Syndrome By Bruce Wilson Special to DG News
ATLANTA, GA -- May 22, 2001 -- Early responders to tegaserod, a 5HT4 receptor partial agonist indicated for the treatment of irritable bowel syndrome (IBS), are likely to continue responding to treatment, according to a study reported at this year’s Digestive Disease Week meeting in Atlanta, Georgia. Speaking on behalf of his colleagues, Dr. Martin Lefkowitz of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, said that the study was an attempt to discover how soon patients would respond to tegaserod, early response being an important factor in clinical practice. Dr. Mueller-Lissner and his associates therefore reviewed three phase III studies of tegaserod to assess the predictive value of early response for continued efficacy over time. The three studies were 16-week, placebo-controlled trials of tegaserod involving a total of 3,199 patients with constipation-prodominant IBS (92 percent of subjects were female). The main efficacy variable, assessed weekly by diary, was the Subject's Global Assessment (SGA) of Relief which evaluated overall well being, abdominal pain and altered bowel habits. Responders were defined as those who had complete or considerable relief 50 percent or more of the time, or complete,considerable, or somewhat relief 100 percent of the time. Persistence of clinical effectiveness was calculated from those who responded after the first month and who continued to respond at study endpoint. According to Dr. Lefkowitz, 81 percent of the patients completed the three studies. At months one, two and three, tegaserod showed a consistent and statistically significant superiority in efficacy over placebo, as measured by the SGA. Patients who showed a response at month 1 continued to show a consistent a significant response throughout the study compared to placebo. Weekly and daily secondary efficacy assessments showed that patients taking tegaserod had less abdominal discomfort and pain (most pronounced over the first five weeks), less constipation, an increase in bowel movements, and better stool consistency throughout the study period. They also had fewer days of bloating and straining, increasing over time to study end. The main adverse events reported with tegaserod was headache (9 percent vs. 5 percent placebo), nausea (6.8 percent vs. 4.7 percent), abdominal pain (6.4 percent vs. 5.7 percent), diarrhea (6.4 percent vs. 2.9 percent), and flatulence (5.7 percent vs. 4.0 percent). Concluding, Dr. Lefkowitz reported, "tegaserod provides relief of abdominal pain, bloating and constipation in female IBS patients. It has a rapid onset of action with effects most prominent in the initial six to eight weeks. The efficacy lasted for 12 weeks and it was safe and well-tolerated."
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