The weight loss medication Xenical® (orlistat) has been shown to be significantly more effective than lifestyle changes alone in managing weight in overweight adolescents, according to new study results presented today at ECO2004
, Prague, Czech Republic.
"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. In addition, childhood and adolescent obesity is closely associated with earlier mortality in adulthood," 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. 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. Xenical has a long-term safety profile unmatched in the field of weight loss.
For further information please contact: Liz Gofton, Shire Health International, Phone: 44-207-471-1518, E-mail: [email protected]