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Modest Efficacy Seen With Tegaserod for Treatment of Irritable Bowel Syndrome or Chronic Constipation: Presented at WCOG

By Danny Kucharsky

MONTREAL, CANADA -- September 19, 2005 -- Tegaserod has modest efficacy at 12 weeks in improving patient satisfaction and selected symptoms in patients with constipation-predominant irritable bowel syndrome (IBS) but further studies of greater length are urgently needed, researchers said here September 14^th at the World Congress of Gastroenterology (WCOG).

Investigator Janet Martin, PharmD, and coordinator, Health Impact Technology Evaluation Centre, London Health Sciences Centre, London, Ontario, Canada, discussed the findings of a meta-analysis during a Presidential Posters presentation, considered the best of WCOG 2005.

According to Dr. Martin, the meta-analysis also found that tegaserod appears to be well tolerated, except for an increased incidence of nonsevere diarrhea.

The meta-analysis was designed to determine whether tegaserod improves patient satisfaction and quality of life at an acceptable level of risk compared with placebo in patients with IBS or chronic constipation.

Tegaserod has been purported to reduce symptoms of IBS or chronic constipation, Dr. Martin noted, but most trials have been powered to adequately rule out clinically significant adverse events. There are few other options for the management of IBS and chronic constipation, she said.

The meta-analysis involved comprehensive searches of Medline and several other databases from the drug's inception until April 2005. Included were 10 tegaserod trials involving 8576 patients; all studies were of 12 weeks duration.

Results show statistically significant, albeit clinically modest, improvement as determined by patient subjective global assessment of relief (odds ratio [OR] 1.41, 95% confidence interval [CI] 1.17-1.70). A modest improvement was seen for bowel movement satisfaction score, abdominal bloating/distention score, mean bowel movements weekly, mean spontaneous bowel movements weekly, and mean complete spontaneous bowel movements weekly.

However, there was no significant improvement for straining score and number of days with excess straining. Quality of life and cost-effectiveness were not reported in any of the trials.

The meta-analysis also found there was a significant increase in tegaserod discontinuation due to adverse events compared with control groups (odds ratio [OR] 1.58, 95% confidence interval [CI] 1.14-2.21). Diarrhea was the most common adverse effect (odds ratio [OR] 2.50, 95% confidence interval [CI] 1.67-3.73) compared with controls, but severe diarrhea did not increase and there was no difference in antidiarrheal use.

There was no difference found between treatment and placebo groups for severe adverse events, headache, nasopharyngitis, ischemic colitis, abdominal surgery, electrocardiographic changes, and death.

Dr. Martin urged that further studies of adequate size and duration be undertaken to determine the efficacy and safety of repeated courses and long-term sustained treatment with tegaserod. Those studies should be of greater than 12-week duration, she concluded.


[Presentation title: Is Tegaserod Effective and Safe for Treatment of Irritable Bowel Syndrome or Chronic Constipation? Meta-Analysis of Randomized Trials. Abstract PR.0673]

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