The Pharmaceutical Journal
Vol 269 No 7222 p637
2 November 2002

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United European Gastroenterology (www.uegf.org)
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5HT₄ agonist is effective IBS treatment

Tegaserod (Zelmac), a 5HT₄ partial agonist, is effective for the treatment of irritable bowel syndrome (IBS) without diarrhoea, according to new data presented at the 10th annual United European Gastroenterology Week congress in Geneva last week.

In a trial of Asian-Pacific patients, researchers randomly assigned, after a baseline period of two weeks, 259 patients to receive tegaserod 12mg daily and 261 patients to receive placebo for 12 weeks, followed by a four-week treatment-free withdrawal period.

The overall discontinuation rate was 16 per cent in the tegaserod group and 12 per cent for the placebo group, with discontinuation due to adverse events occurring in 7.7 per cent of patients in the tegaserod group and 3.1 per cent of patients taking placebo. Diarrhoea was the most common adverse event. Discontinuation due to diarrhoea occurred in 2.3 per cent of patients taking tegaserod and none of those taking placebo.

As a result, the researchers say that tegaserod is a safe, effective and well tolerated treatment for non-diarrhoea IBS in an Asian-Pacific population, with a sustained effect over 12 weeks.

In another, phase III, study, published in Alimentary Pharmacology and Therapeutics recently (2002;16:1877), new data show that tegaserod provides rapid relief from abdominal pain, discomfort, bloating and constipation associated with IBS in women. Researchers randomly assigned 1,519 women, from 131 centres in the United States, to receive tegaserod 6mg twice daily or placebo for 12 weeks. Treatment was preceded by a four-week base-line period without treatment and followed by a four-week open withdrawal period.

The researchers say that patients treated with tegaserod experienced less bloating, more bowel movements with a softer consistency and less need to strain. IBS symptoms returned rapidly after cessation of treatment, but did not return to base-line within the four-week withdrawal period. They conclude that “the efficacy of tegaserod in IBS patients persists for at least 12 weeks of treatment”.

Marketing approval has now been gained in the US following a request by the US Food and Drug Administration for more data about the drug (PJ, 23 June 2001, p845). Novartis, the company developing tegaserod, plans to submit an application for a licence for the product to the European Agency for the Evaluation of Medicinal Products. However, it is not known when tegaserod is expected to receive a licence in the United Kingdom.