Tegaserod (Zelnorm)...New Drug for IBS (cont.)
How effective and safe is tegaserod?
Tegaserod was found to be more effective than placebo in increasing the frequency of stools, relieving abdominal pain and discomfort, and decreasing the sensations of bloating among women subjects. There was an insufficient number of male participants to draw conclusions about the effectiveness of treatment in men. The beneficial effects of treatment started early (during the first week of treatment) and were sustained throughout the 12-week period of study.
Diarrhea was the only observed side effect. Diarrhea typically occurred early during treatment and quickly resolved even if treatment was continued.
There was no effect of tegaserod on blood counts, liver and kidney tests, EKG, blood pressure, pulse, and body weight. A medication similar to tegaserod, called cisapride (Propulsid), also stimulated intestinal muscle contractions, but cisapride was withdrawn from the market due to rare but potentially fatal effects on the electrical rhythm of the heart. So far, there have been no reports of rhythm disturbances related to Tegaserod.
Based on this study and two additional studies with similar findings, the FDA approved tegaserod for up to 12 weeks of treatment for women with constipation-predominant IBS.
What is the recommended dose of tegaserod?
Are there any precautions when taking tegaserod?
Are there other issues to be considered when using tegaserod?
Tegaserod has been approved for relieving constipation, abdominal pain, and bloating in patients with IBS, yet there are many other causes of constipation unrelated to IBS. Accurate diagnosis and careful patient selection is vitally important to ensure that problems other than IBS are not missed.
IBS is a chronic disorder, yet tegaserod has been approved for only 12 weeks of treatment at a time. Until long-term (more than 12 weeks in this case) information on safety and efficacy become available, doctors must decide whether or not to extend treatment beyond 12 weeks.
Though less common than women, men also suffer from IBS, yet tegaserod is
approved only for women. Before more data on men become available, doctors must
decide whether or not to offer tegaserod to men. I have prescribed tegaserod for
three patients; one of them is a man. This man has severe, debilitating,
prolonged IBS with constipation that has failed all treatments. I hope it works!
Last Editorial Review: 10/14/2002
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