"This is good news for physicians, parents and young people struggling with teenage overweight and obesity. Excess weight in adolescents has short and long-term effects on health, most notably increased risk of high blood pressure, raised cholesterol and the development of type 2 diabetes. 2,3,4 In addition, childhood and adolescent obesity is closely associated with earlier mortality in adulthood,5" said principal study investigator Professor Jean-Pierre Chanoine, British Columbia's Children's Hospital, Vancouver, Canada. "Obesity is a global epidemic, and is now the most common teenage health problem in the developed world. These study results demonstrate Xenical's benefits as an effective and safe therapy that will contribute to helping this important patient group."
The one year study, involving 539 adolescents aged 12 to 16, evaluated the efficacy and safety of Xenical in conjunction with lifestyle changes (a mildly reduced-calorie diet, exercise and behavioural therapy) compared to the efficacy of lifestyle changes alone.
Study results showed that adolescents treated with Xenical1 had:
- significantly greater reduction in fat mass (- 2.4 kg vs. - 0.38kg) (p=0.033).
- significantly greater decrease in waist circumference (- 2.39% vs. - 0.87%) (p=0.013)
- significantly reduced BMI compared with adolescents receiving lifestyle changes alone ( -0.67 kg/m2 vs. + 0.17 kg/m2) (p=0.001)
- a greater proportion of Xenical treated adolescents achieved a =5% and =10% decrease in BMI (27% vs. 16% and 13.3% vs. 4.5% respectively)
- Xenical was well tolerated and reported adverse events were similar to those seen in adults.
In December 2003 the U.S. Food and Drug Administration (FDA) approved labelling for use of Xenical in the management of obese adolescents aged 12 to 16 years. This was the first approval of its kind for a prescription weight-loss treatment.
This new study further complements the outstanding bank of data illustrating Xenical's efficacy, safety and tolerability in adults.6,7 In addition to significant weight reduction, Xenical has also been shown to reduce the risk of developing diabetes (in the landmark XENDO Study) and improve cardiovascular risk factors in adults who are overweight or obese.8 Xenical has a long-term safety profile unmatched in the field of weight loss. 6
Notes to Editors:
Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30 per cent to effectively promote weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike appetite suppressants, it does not act on the brain. Since it was first marketed in 1998, there have been more than 19.5 million patient treatments with Xenical world-wide. Xenical is licensed for weight management in 149 countries around the world. For further information please go to: http://www.
About Xenical Weight Management Programmes
Roche has developed Xenical Weight Management Programmes (WMPs) for healthcare professionals to use with their patients. The programme aims to help patients set and reach realistic weight goals while modifying their dietary intake and behaviour in the long-term. The programmes are individually tailored to help people achieve their weight loss goals, and maintain weight loss, through healthy eating, physical activity, behaviour modification and pharmacotherapy.
Roche provides free patient support programmes in around 50 countries worldwide to help people taking Xenical. Recent data demonstrated that patients enrolled in Xenical WMPs can significantly improve the levels of weight loss achieved and can increase their overall satisfaction and compliance with treatment.
Headquartered in Basel, Switzerland, Roche is an innovation driven global healthcare leader focused on pharmaceuticals and diagnostics. Roche is world wide number one in diagnostics, oncology and transplantation and has a leading position in Virology. With products and services that address the prevention, diagnosis and treatment of diseases, the company contributes broadly to the enhancement of people's health and quality of life. Roche employs some 62 000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group.
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Shire Health International
1. Chanoine J-P, Hauptman J, Boldrin M, Smith J, and Hampl S. Beneficial effects of orlistat on weight and body composition in obese adolescents. Poster presented at the 13th European Congress on Obesity (ECO), Prague, Czech Republic. 26 May 2004.
2. Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics 1998; 101: 518-25.
3. Caprio S, Hyman LD, McCarthy S, et al. Fat distribution and cardiovascular risk factors in obese adolescent girls: importance of the intra abdominal fat depot. Am J Clin Nutr 1996; 64: 12-17.
4. Pinhas-Hamiel O, Dolan LM, Daniels SR, et al. Increased incidence of non-insulin-dependent diabetes mellitus among adolescents. J Pediatr 1996; 128: 608-15.
5. Must A, Jacques PF, Dallal GE, et al. Long-term morbidity and mortality of overweight adolescents. A follow-up of the Harvard Growth Study of 1922 to 1935. N Engl J Med 1992; 327: 1350-5.
6. Torgerson JS, et al. XENDOS: a randomised study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care 2004;27(1):155-61.
7. Kelly D. Effects of Moderate Weight Loss and Orlistat on Insulin Resistance, Regional Adiposity and Fatty Acids in Type 2 Diabetes Mellitus. Diabetes Care 2004;27(1):33-40.
8. Torgerson J. XENDOS - A Unique Advantage. Presented at the satellite symposium "Making the right moves for success" at the European Congress on Obesity; May 2003, Helsinki, Finland.