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Big Benefits for Obese Teenagers Who Lose Weight Early With Orlistat

SYDNEY, AUSTRALIA -- September 12, 2006 -- The weight loss medication Xenical® (orlistat) can safely help obese adolescents to lose excess weight, providing not only a major health benefit but also considerable improvements in self-esteem and quality of life.1 Furthermore, those teenagers who experienced a greater weight loss during the first three months of treatment also achieved an average weight loss over three times greater that those with a slower response.

These data were presented at the International Congress on Obesity (ICO) in Sydney, Australia.

Obesity is the most prevalent nutritional disorder among children and adolescents in the majority of developed countries.2 It is associated with an increased risk of health problems such as hyperlipidaemia (excess lipids or fats in the blood) and type 2 diabetes, and can result in decreased emotional and physical quality of life.3-5 Studies show that severely obese children and adolescents have a similar quality of life as those diagnosed as having cancer.3 Childhood obesity also results in an increased risk of health problems and mortality in adulthood.6,7

"The problem of adolescent obesity has reached alarming levels, with dire health consequences," said Professor Jean-Pierre Chanoine, Head of Endocrinology and Diabetes Unit, British Columbia Children's Hospital, Vancouver, Canada and lead study investigator. "It's reassuring to know we have a safe and effective treatment option with Xenical. The significant benefits seen in adolescents who respond early also provide a useful predictor for long-term treatment success."

The retrospective analysis looked at obese adolescents aged 12-16 years treated for 1 year. Results showed:1
• Xenical produced significantly greater reductions in weight vs. placebo (-2.4kg vs. -0.4kg)
• Adolescents who responded early to treatment showed additional and substantial reductions in body weight with Xenical (-7.6kg; BMI -3.7kg/m2). Early response was independent of age, gender and ethnicity.
• Xenical was shown to significantly improve quality of life vs. placebo with greater improvements in physical appearance, social acceptance, athletic competence and self-worth vs. placebo. Assessments were based on Harter's self-perception profile.

Xenical is the only weight loss medication that has safety and efficacy data on use in adolescents 12 years and older included in its label.*

*Xenical is indicated for use in adolescents (pharmacodynamic section) in the USA, EU (EMEA), Bahrain, China, Cuba, Hong Kong, Mexico, Singapore, Switzerland and Taiwan.

About Xenical® (orlistat)
Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30% to effectively promote weight loss. The efficacy and safety of Xenical has been proven in an extensive clinical trials programme, with over 100 Phase III/IV trials, in over 30,000 patients. Xenical is the most extensively studied weight loss medication in the world, and the only weight loss drug studied up to 4 years.8

People can lose up to twice as much weight with Xenical compared to lifestyle changes alone.9,10 Xenical also improves cardiovascular risk factors, reduces the risk of developing type 2 diabetes, and improves components of the metabolic syndrome.8,11 XENDOS was the first study to show that treatment with a weight loss medication, Xenical, can significantly reduce the risk of developing type 2 diabetes.8

Xenical is well tolerated and unlike appetite suppressants, it does not act on the brain. Xenical is suitable for use in a broad range of patients, including those with hypertension, dyslipidaemia, type 2 diabetes and multi-morbidities. Since Xenical was first marketed in 1998, there have been more than 25 million patient treatments world-wide. Xenical is licensed for use in 149 countries around the world.

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.

REFERENCES:
1. Chanoine J-P, Hauptman J, Boldrin M. Weight reduction in obese adolescents achieving early response to orlistat. Poster presented at the 10th International Congress on Obesity, Sydney Australia.
2. International Diabetes Federation. Diabetes and Obesity: Time to Act. 2004. 26-27.
3. Schwimmer JB, Burwinkle TM, Varni JW. Health-related quality of life of severely obese children and adolescents. JAMA. 2003;289:1813-1819.
4. Williams J, Wake M, Hesketh K, Maher E, Waters E. Health-related quality of life of overweight and obese children. JAMA. 2005; 293:70-76.
5. Goran MI, Ball GD, Cruz ML. Obesity and risk of type 2 diabetes and cardiovascular disease in children and adolescents. J Clin Endocrinol Metab. 2003; 88: 1417-1427.
6. Must A, Jacques PF, Dallal GE, Bajema CJ, Dietz WH. Long-term morbidity and mortality of adolescents: a follow-up of the Harvard Growth Study of 1922 to 1935. NEJM. 1992. 327 (19): 1350-5
7. Must A. Morbidity and mortality associated with elevated body weight in children and adolescents. Clin Nutr. 1996;63 (suppl 3): S445-S447.
8. 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.
9. Broom I, Wilding J, Stott P, et al. Randomised trial of the effect of orlistat on body weight and cardiovascular disease risk profile in obese patients: UK Multimorbidity Study. Int J Clin Pract. 2002. 56(7): 494-9.
10. Bakris G, Calhoun D, Egan B, et al. Orlistat improves blood pressure control in obese subjects with treated but inadequately controlled hypertension. J Hypertens. 2002. 20 (11):2257-67.
11. Holt R, et al. Orlistat reduces features of the metabolic syndrome: the XENDOS study. Diabetes Obes Metab. 2003. 5(5):356.


SOURCE: Roche

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