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Clinical Trial Shows Tegaserod Relieves Multiple Symptoms of IBS

Basel, Switzerland, April 24/PRNewswire/ -- A large Asian-Pacific study of 520 patients, published in the current issue of Gut (vol 52, no 5), demonstrates Zelmac(R) (tegaserod) is effective in relieving the abdominal discomfort/pain, bloating and constipation experienced by patients with Irritable Bowel Syndrome (IBS), excluding those with diarrhoea.

Zelmac-treated patients experienced significantly greater relief from their IBS symptoms, with approximately a 20% (56% vs. 35%; p "This study contributes to the growing body of scientific evidence that tegaserod is effective for the treatment of IBS," said Professor John Kellow, of the Royal North Shore Hospital, University of Sydney, Australia and primary study investigator. "The study demonstrated that Zelmac, whilst being taken in the recommended dose for at least 12 weeks, can provide sustained and rapid relief in patients experiencing the abdominal pain, discomfort and bloating associated with this condition."

Clinical Data
The study objective was to assess the efficacy and safety of 6 mg b.i.d. (twice a day) treatment of Zelmac in 520 Asian-Pacific patients diagnosed with IBS using the Rome criteria, excluding those patients whose primary altered bowel habit was diarrhoea. After a two-week baseline period, patients were randomised to receive Zelmac (n=259) or placebo (n=261) over a 12-week double-blind treatment period, followed by a four-week withdrawal period. Efficacy was assessed weekly by the overall relief of IBS symptoms. The primary and secondary efficacy variables were the response profiles over weeks 1-4 and weeks 1-12 respectively. Additional secondary efficacy variables included relief of individual symptoms of IBS (as listed above).

The overall frequency of adverse events was comparable between the two study groups with headache as the most common adverse event (12% Zelmac group vs. 11.1% placebo group). Diarrhoea was also more frequent in the tegaserod group, and was generally mild, transient and typically resolved with continued treatment. The overall discontinuation rate was 7.7% in the Zelmac group and 1.5% for the placebo group.

While the prevalence of IBS varies by region, recent studies estimate that approximately 10-15% of the population is affected worldwide. It is further estimated that indirect and direct healthcare expenditures due to IBS cost the eight most industrialised countries of the world US$41 billion per year.

About Irritable Bowel Syndrome (IBS)
IBS is characterised by abdominal pain and discomfort, bloating, and altered bowel function (constipation and/or diarrhoea). Until recently, the cause of IBS has been poorly understood and under appreciated. However, in recent years, new research has yielded a better understanding of IBS and its causes. People who have abdominal pain and discomfort, bloating and constipation associated with IBS may have altered sensitivity and altered motility of their lower GI tract. This may be due to the way their lower GI tract reacts to changes in 5HT (serotonin), a naturally occurring chemical, in their body that regulates motility and perception of pain and discomfort in the intestinal system.

About Zelmac
Zelmac is the first in a new class of medicines, known as 5HT4 (serotonin type 4) receptor agonists developed especially for the treatment of the multiple symptoms associated with IBS with constipation. By activating 5HT4 receptors in the gastrointestinal tract, Zelmac normalises impaired motility and reduces sensitivity of the intestinal tract. In clinical studies, significantly more patients experienced a general relief of symptoms when treated with Zelmac, such as a decrease in abdominal pain, bloating and constipation. In most patients, the onset of relief occurred within just one week. The medicine was well tolerated and showed a profile of side effects similar to that of placebo.

Zelmac was discovered and developed by Novartis. Zelmac, known in the United States, Canada and South Africa as Zelnorm, is approved in more than 40 countries including, Switzerland, Canada, the United States and Brazil. In the Asian Pacific region, Zelmac is approved for use in Australia, Thailand, Singapore, Vietnam and Indonesia.

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