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Xenical Twice As Effective As Diet AloneDUBLIN, Ireland, June 19, 1997Results from the first large clinical studies of Xenical (generic name is orlistat), the first of a new class of non-systemic anti-obesity medications demonstrate that the drug is significantly more effective in weight reduction than diet alone. The studies, which were presented today at the 8th European Congress on Obesity (ECO), in Dublin, are one and two year efficacy studies comparing the use of Xenical 120mg tid, taken with a mildly reduced calorie diet containing approximately 30 percent of calories from fat, against placebo with the same diet. Results show that three out of four patients taking Xenical reach a medically meaningful weight loss. This was twice the loss seen in patients taking placebo. According to lead investigator, Professor Stephan Rossner from the Karolinska Hospital, Stockholm, "The average patient in the studies weighed 220 lbs and lost 20 lbs, or about 10 percent of body weight.'' Importantly, he said, most patients managed to maintain their new weight. Xenical significantly prevents the regain of the weight lost -- weight regain being the most common problem associated with weight loss. "It may not seem like much, but a five to ten percent reduction in weight does significantly reduce the occurrence and severity of obesity related conditions, such as hypertension, diabetes and heart disease,'' said Dr. Paul Whitsitt, an Oshawa, Ontario, family physician in attendance at ECO. "Therefore, the focus should not be on achieving 'ideal' weight, but what weight reduction is necessary to make one healthy. Xenical in combination with dietary management appears to be a novel approach to achieving these goals.'' In addition, Xenical-treated patients had statistically significant reductions in some of the important risk factors that make obesity such a life-threatening disease. These included significant reductions in total and LDL cholesterol, systolic and diastolic blood pressure, and showed improvements in blood concentrations of glucose and insulin. Xenical acts by blocking the action of lipases which normally break down fat enabling fat to be absorbed through the intestinal wall. Excess fat in the diet is a major cause of obesity. Xenical does not work on the brain to suppress appetite, and does not enter the blood stream. In the clinical studies, Xenical was well tolerated, and was not associated with any serious medical side effects. Xenical has recently been recommended for approval by the U.S. Food and Drug Administration's Endocrinology and Metabolic Drugs Advisory Committee for long term treatment of obese people (BMI more than 30kg/m2) and in those with BMI more than 27kg/m2 who have risk factors. It is currently being reviewed by the Health Protection Branch of Health Canada. Xenical is the product of research by F. Hoffmann-La Roche Ltd. in Basel, Switzerland. Roche Canada is a Mississauga-based pharmaceutical company with over 500 employees across the country. The company is dedicated to the research and development of innovative medicines to help treat human illness. It is also heavily involved in the vitamins, fine chemicals and diagnostic equipment areas. |
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