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Tegaserod in the treatment of irritable bowel syndrome (IBS) with constipation as the prime symptom

Authors Peter Layer, Jutta Keller, Helena Loeffler, Andreas Kreiss

Published 15 March 2007 Volume 2007:3(1) Pages 107—118

Peter Layer1, Jutta Keller1, Helena Loeffler2, Andreas Kreiss2

1Department of Internal Medicine, Israelitisches Krankenhaus, Hamburg, Germany; 2Clinical Development, Novartis Pharma GmbH, Nuremberg, Germany

Abstract: Irritable bowel syndrome with constipation (IBS-C) as the predominant bowel symptom is a prevalent disorder, characterized by recurring abdominal pain/discomfort, bloating, and constipation, and imposes a significant socio-economic burden. Traditional treatments generally address just one of the multiple IBS symptoms. The efficacy and safety profile of tegaserod, a serotonin 5-HT4 receptor agonist, has been demonstrated in several randomized, placebo-controlled, and open-label trials. This review discusses the major clinical trials of tegaserod, which have involved 8948 IBS patients. Overall, data reveal that tegaserod is an effective treatment for IBS-C, providing statistically significant relief of overall and multiple individual IBS-C symptoms (abdominal pain/discomfort, bloating, and constipation) in both placebo-controlled and “real-life” open-label settings. Repeat treatments with tegaserod were also shown to be effective, which is noteworthy given the chronic and episodic nature of IBS. Moreover, tegaserod was associated with improvements in patients’ quality of life and work productivity. Data also indicate that tegaserod is well tolerated over the short-term (4 weeks), long-term (12 months), and repeated treatments. Diarrhea is the only adverse event consistently associated with tegaserod and was generally mild and transient. Overall, tegaserod has been demonstrated to offer effective and well-tolerated treatment of IBS-C, providing patients with meaningful symptom relief.

Keywords: efficacy, IBS, safety, serotonin, tegaserod, Zelnorm

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