Weight loss medicine Xenical ( Orlistat ) has received European approval to include clinical, safety and efficacy data in the label on the use in obese adolescents aged 12 years or over.
The label change has been approved following the results of a major study that shows Xenical to be highly effective in helping obese young people to lose weight.
As a result of this change, physicians may now consider Xenical as an effective option in the management of obesity in adolescents.

In Europe in the last few years there has been a significant increase in obesity in children and adolescents, with as many as one in four affected in some regions.
Obese children tend to become obese adults, and they carry a high risk of acute and chronic diseases, leading to reduced life expectancy.
Treatment and prevention of childhood obesity has been identified as a healthcare priority in Europe.

“By studying the use of Xenical in obese adolescents aged 12 and over, we have now shown that the drug can benefit young people as much as adults. Xenical is now the only weight loss treatment in the US and EU that provides guidance from clinical trials in its label on use in this population,” said William M. Burns, CEO Roche Pharma.

The label change is based on data from a large study, published in JAMA, in which 539 obese adolescent patients received either 120 mg Xenical or placebo three times daily, alongside a reduced-calorie diet and exercise for 1 year.
Weight loss was tracked using changes in the adolescents’ Body Mass Index ( BMI ), a measure that takes into account not only the changes in body weight but also the changes in height which occur in growing adolescents.

Study results were consistent with those seen in adults and showed at the end of treatment:

• Adolescents treated with Xenical had a significantly reduced BMI ( decrease of 0.55 kg/m2 compared to an increase of 0.31 kg/m2 in the placebo group ).

• Almost twice as many adolescents treated with Xenical reduced by =5% their BMI ( 26.5% vs 15.7% ) and their body weight ( 19% vs 11.7% )

• Adolescents treated with Xenical had a greater decrease in body fat ( 2.4 kg vs 0.4 kg )

• Waist circumference decreased significantly in Xenical recipients, but increased in placebo recipients ( –1.33 cm vs +0.12 cm ).

• Adolescents who responded to treatment ( =5% weight loss at 12 weeks ) had a reduction in body weight of 7.6 kg and a BMI decrease of 3.7 kg/m2.

• Treatment was well tolerated, with adverse events generally similar to those observed in adults.

These data, from the largest and longest study of a weight loss medication in adolescents, add to the extensive evidence base including safety, and clinical experience gained with Xenical since it was first marketed in 1998.

“Access to pharmacotherapy such as Orlistat to complement diet and exercise will be important for physicians and patients trying to combat the growing trend of adolescent obesity. It means that the medical profession will have a new weapon to help adolescents lose weight, and stop them progressing to become overweight adults with the associated health complications” commented lead investigator Jean-Pierre Chanoine, Endocrinology and Diabetes Unit, British Columbia Children's Hospital, Vancouver, Canada.

Xenical has a unique mode of action, it works locally in the gut to prevent dietary fat absorption by around 30 percent and effectively promotes weight loss.
It is the most extensively studied pharmacological weight management treatment to date, with over 30,000 overweight or obese patients participating in clinical trials with Xenical, including the 4 year XENDOS study.
It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss.
Xenical was approved in December 2003 for use in adolescents 12 years and above in the US.

Source: Roche, 2005


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