Hoffmann-La Roche Limited, Canada, has initiated a clinical trial to evaluate its weight loss medication Xenical(R) (orlistat) in overweight adolescents. Xenical is the only Health Canada-approved prescription medication for adults that reduces the absorption of dietary fat. The new trial will study the safety and efficacy of Xenical in conjunction with a reduced-calorie diet in the treatment of overweight adolescents 12 to 16 years of age.
According to a study reported in the November 28, 2000 issue of the Canadian Medical Association Journal (CMAJ), the rates of overweight children and adolescents in Canada are increasing. In 1996, rates for boys increased to 28.8 per cent and girls to 23.6 per cent, both from 15 per cent in 1981. The prevalence of obesity in children has more than doubled over that period, to 13.5 per cent for boys and 11.8 per cent for girls, both from five per cent.
"We are well aware that the prevalence of being overweight in children and adolescents is growing and we believe this clinical trial is a positive step towards providing an effective solution to this problem," said Dr. Daniele Pacaud, Assistant Professor of Medicine, University of Calgary. "The safety and efficacy of Xenical have been demonstrated in many clinical studies in adults. Xenical's unique non-central nervous system mode of action could make it a good option for adolescents who are overweight."
The trial, involving approximately 450 patients in Canada and the United States, will be conducted in six centres across Canada, including Vancouver, Calgary, Winnipeg, Montreal and Halifax and 29 centres in the United States. All participants will receive nutritional and behaviour modification counseling throughout the study.
The CMAJ study also reports that excessive body mass during childhood and adolescence is associated with an increased risk of becoming overweight in adulthood, as well as with higher morbidity and mortality rates. In addition, cases of type 2 diabetes mellitus, high cholesterol and hypertension are becoming more common in severely overweight children.
Xenical is a safe and effective weight management treatment for overweight and obese patients. Xenical is the only peripherally-acting prescription lipase inhibitor for weight loss, maintenance of lost weight, and the reduction of risk of weight regain after prior weight loss, when used with a reduced-calorie diet. Xenical blocks about one-third of the fat in food from being digested. Since it was first marketed in 1998, there have been more than eight million patient treatments with Xenical worldwide.
Compared to diet alone, weight loss with Xenical also resulted in improvements in many obesity-related cardiovascular risk factors such as high blood pressure, high cholesterol, and diabetes.
F. Hoffmann-La Roche Limited is an international healthcare company committed to the discovery and development of new and innovative medicines to help treat human illnesses. Represented in more than 70 countries, the company is a world leader in the research and development of innovative pharmaceuticals, vitamins, fine chemicals and diagnostic equipment. The company is active in a broad range of therapeutic categories that include: AIDS, cardiology, dermatology, infectious disease, obesity, transplant, oncology and virology.
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