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Title: New Data Shows Tegaserod is Safe and Well Tolerated In Treating Functional Dyspepsia: Presented at DDW

"New Data Shows Tegaserod is Safe and Well Tolerated In Treating Functional Dyspepsia: Presented at DDW"

Study Results Presented at the 33rd Annual Digestive Disease Week Meeting Show Trend Towards Improvement of Upper GI Symptoms in Female Patients with Normal Gastric Emptying SAN FRANCISCO, CA -- May 21, 2002 -- New data presented today at the 33rd annual Digestive Disease Week (DDW) demonstrates that tegaserod is safe and well tolerated, showing a trend towards improving upper gastrointestinal symptoms in female functional dyspepsia patients with normal gastric emptying. "Until recently, the use of prokinetic agents such as tegaserod in the treatment of patients with functional dyspepsia and normal gastric emptying had not been demonstrated," said Professor Jan Tack, M.D., Ph.D, lead author of the study and Professor at the Department of Gastroenterology and Principal Researcher, Centre for Gastroenterological Research at the University of Leuven, Belgium. "The data from this study is particularly promising for female patients who suffer from functional dyspepsia. While additional trials will have to be conducted, the outcome of this research is important news for the millions of patients who suffer from this debilitating condition." Study Results The findings show that female patients taking a 12 mg dose of tegaserod had potential benefit over placebo, with relief of symptoms at least 50 percent of the time. Those patients taking a 12 mg dose also exhibited beneficial effects on early satiety and postprandial fullness and experienced more days free of early satiety compared to the placebo group. Additionally, the percentage of days free of fullness was 22 in the placebo group versus 33 in the 12 mg group. The most adverse events reported were diarrhea, headache and nausea. Incidence of these adverse events was similar in all treatment groups except for diarrhea. The discontinuation rate due to diarrhea was low. Study Methods Professor Tack of the University of Leuven Centre for Gastroenterological Research, Leuven, Belgium was the principal investigator of this multi-center, double-blind, placebo-controlled study, where 271 patients were randomly assigned to 1 mg, 4 mg and 12 mg doses of tegaserod, or placebo for a period of eight weeks. The baseline characteristics of the patients were similar across all treatment groups: 71 percent were female with a mean age of 45, and 93 percent were less than 65 years old. The primary outcome parameter was defined by the percentage of weeks patients felt satisfactory relief of functional dyspepsia symptoms. Secondary endpoints included daily assessment of individual upper GI symptoms on a 4 point scale (1 -- none; 4 -- severe). About Tegaserod Tegaserod is a 5-HT4 receptor partial agonist with a unique mechanism of action to treat the underlying mechanisms in disorders of gastrointestinal motility and function. Tegaserod acts by stimulating 5-HT4 receptors in the gastro-intestinal tract to coordinate peristalsis, stimulate motility and modulate visceral sensitivity. Tegaserod is approved for the treatment of irritable bowel syndrome with constipation in female patients in over 20 countries including Australia, Brazil, Switzerland, Canada and several other Latin American countries, such as Mexico, Argentina, Venezuela and Columbia. Novartis continues to work with the European Agency for the Evaluation of Medicinal Products (EMEA) to help bring the benefits of this important new therapy to patients in need. About Functional Dyspepsia Functional dyspepsia is a frequently occurring disorder, characterized by early satiety, abdominal distention, fullness, nausea and burning pain localized to the upper abdomen or chest that has no specific cause or diagnostic evaluation. Eating often worsens symptoms. Underlying mechanisms include abnormalities of the sensory and motor function of the stomach and the duodenum. While the condition is mostly benign, it impacts on patient's quality of life and may lead to weight loss in severe cases. About the Centre for Gastroenterological Research The Centre for Gastroenterological Research at the University Hospitals in Leuven, founded by emeritus Professor Gaston Vantrappen and now headed by Professor Jozef Janssens, has a longstanding tradition and is at the leading edge in studying and treating gastrointestinal motor and sensory disorders. The centre integrates research in the field of neurogastroenterology and motility from the basic cellular level, through animal models and studies in healthy volunteers, up to pathophysiological and clinical studies in patients. CONTACT: Chantal Beaudry/John McInerney Ruder Finn 212-583-6400 SOURCE: University Hospitals in Leuven

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