Safety and Tolerability of Tegaserod in Irritable Bowel Syndrome

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Safety and Tolerability of Tegaserod in Irritable Bowel Syndrome
Objectives: To discuss the need for safe and effective therapy for patients with irritable bowel syndrome (IBS) and to provide up-to-date information on the safety and tolerability profile of tegaserod, a novel treatment for women with IBS whose primary bowel symptom is constipation.
Data Sources: PubMed and abstracts from gastroenterology conferences were searched through October 2003 using the following search terms: irritable bowel syndrome, IBS, tegaserod, cisapride, alosetron, systematic review, safety, tolerability, serotonin, 5-HT, 5-HT3 receptor antagonist, and 5-HT4 receptor agonist; all information on the safety and tolerability of tegaserod published up to October 2003 is included.
Data Synthesis: A comprehensive review of the medical literature (through 2001) finds no adequate therapies that address the multiple symptoms of IBS. Traditional agents, although occasionally effective, often cause adverse effects. Tegaserod, a selective serotonin type 4 receptor (5-HT4) partial agonist, overcomes a number of obstacles associated with traditional therapies. Important information for pharmacists about the safety and tolerability of tegaserod is presented.
Conclusion: Tegaserod is effective in treating multiple IBS symptoms in women with IBS whose primary bowel symptom is constipation, and it is safe and well tolerated. Keywords: Irritable bowel syndrome, tegaserod, cisapride, alosetron, serotonin.

Tegaserod (Zelnorm, Novartis) was approved in July 2002 for the treatment of IBS in women whose primary bowel symptom is constipation (IBS-C). The first agent in a novel drug class (aminoguanidine indoles), tegaserod targets the multiple symptoms of IBS-C (abdominal pain or discomfort, bloating, and constipation) and has an excellent safety profile.

Tegaserod improves the symptoms of IBS-C by promoting motility along the entire gastrointestinal (GI) tract, increasing intestinal secretions, and decreasing visceral sensitivity. The previous withdrawal from the marketplace of two other agents with promotility properties -- cisapride and alosetron -- prompted safety concerns in the minds of health care professionals and the public.

The purpose of this paper is to clarify the safety concerns and to update pharmacists on the safety and tolerability profile of tegaserod.

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