# New study shows Zelmacï¿½ effective and safe for people with non-diarrhea IBS



## Jeffrey Roberts (Apr 15, 1987)

http://dominoext.novartis.com/NC/NCPRRE01....30?OpenDocument New study shows Zelmacï¿½ effective and safe for people with non-Diarrhea Irritable Bowel Syndrome...10/21/2002Large study in Asian-Pacific population demonstrates Zelmac significantly improved symptomsBasel, 21 October 2002 ï¿½ New data presented today showed Zelmacï¿½* (tegaserod) is effective, safe and well tolerated for the treatment of non-Diarrhea Irritable Bowel Syndrome (non-D-IBS). The data were presented at the 10th Annual United European Gastroenterology Week (UEGW) congress in Geneva. "These results showed tegaserod was effective in providing satisfactory relief of abdominal pain, discomfort and bloating for patients with non-Diarrhea Irritable Bowel Syndrome," said Professor John Kellow, of the Royal North Shore Hospital, University of Sydney, Australia and primary study investigator.Zelmac-treated patients experienced significantly greater relief from their IBS symptoms, with approximately a 20 % improvement versus placebo during the first four weeks of a twelve-week clinical trial. A consistent pattern of improvement for other efficacy variables, including response profiles and individual symptom relief, were observed in Zelmac-treated patients, with a significant effect on the number of days without abdominal discomfort/pain and bloating in the last four weeks of treatment. "These results are very encouraging and demonstrate the efficacy and safety of Zelmac for the many patients with non-Diarrhea Irritable Bowel Syndrome," said Joerg Reinhardt, Head of Development, Novartis Pharma AG. The study objective was to assess the efficacy and safety of 12 mg/d treatment of Zelmac in 520 Asian-Pacific patients with non-D-IBS. After a two-week placebo-free baseline period, patients fulfilling the Rome II criteria for non-D-IBS were randomized to receive Zelmac (n=259) or placebo (n=261) over a 12-week double-blind treatment period, followed by a four-week placebo-free 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 efficacy variables included intensity of abdominal discomfort/pain and bloating.The overall frequency of adverse events was comparable between the two study groups, with diarrhea as the most common adverse event (10.4% Zelmac group vs. 4.2% placebo group). The overall discontinuation rate was 16% in the Zelmac group and 12% for the placebo group.About Irritable Bowel Syndrome (IBS)IBS is characterized by abdominal pain and discomfort, bloating, and altered bowel function (constipation and/or diarrhea). 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 serotonin (5HT), a naturally occurring chemical in their body that regulates motility and perception of pain and discomfort in the intestinal system. About ZelmacZelmac is the first in a new class of medicines, known as serotonin-4 receptor agonists (5HT4 agonists) developed especially for the treatment of the multiple symptoms associated with IBS with constipation. By activating 5HT4 receptors in the gastrointestinal tract, Zelmac normalizes 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 30 countries including Australia, Switzerland, Canada, the United States and Brazil. The foregoing press release contains certain forward-looking statements related to the business of Novartis, which can be identified by implicit or explicit discussions regarding potential future sales of Zelmac/Zelnorm. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that future sales of Zelmac/Zelnorm will reach any particular level. Management's expectation regarding the commercial potential of tegaserod in any market could be affected by, amongst other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com. # # #* In the U.S., Canada, and South Africa: Zelnormï¿½ (tegaserod maleate), all other countries: Zelmacï¿½ (tegaserod) _______________________________ï¿½ 2001 Novartis AG


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