News Release

Xenical(R) significantly improves 5 out of 5 Metabolic Syndrome abnormalities

New outcomes from the landmark XENDOS study

Peer-Reviewed Publication

Shire Health International

Xenical® is significantly more effective than diet alone in reducing weight and simultaneously improving cardiovascular risk factors in patients with Metabolic Syndrome, according to new outcomes from the landmark XENDOS study, presented today at the 12th European Congress on Obesity (ECO), Helsinki, Finland.1

Metabolic Syndrome, otherwise known as Syndrome X or insulin resistance syndrome, describes a 'cluster' of 3 or more risk factors, such as high waist measurement, increased fasting glucose levels, abnormal blood lipid levels and high blood pressure in a single patient, leading to an increased risk of cardiovascular disease. Up to one in five people in Western countries is considered a 'cardiovascular time-bomb' because they have Metabolic Syndrome.2 Weight loss is the only intervention that has been shown to improve all of the cardiovascular risk factors seen in patients with Metabolic Syndrome. 3

This new analysis from XENDOS examined the effects of treatment with Xenical in patients with Metabolic Syndrome, based on criteria from the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP III)*. Forty per cent of XENDOS study participants had Metabolic Syndrome.

In Xenical-treated patients results showed:

  • More than twice as much weight loss as those on diet alone (-6.4kg vs -2.9kg)
  • A significantly greater reduction in waist measurement compared to those on diet alone (-6.1cm vs -3.8cm)
  • A significantly greater reduction in systolic and diastolic blood pressure compared to those on diet alone (-5.4mmHg vs -3.5mmHg and -3.1mmHg vs -2.0mmHg respectively)
  • A significantly greater reduction in triglyceride levels compared to those on diet alone (-6.3% vs -5.5% decrease from baseline)
  • Significantly lower fasting plasma glucose levels compared to those on diet alone (0.08mmol/L vs 0.22mmol/L)
  • An increase in HDL (good) cholesterol (+9.0% from baseline)

In addition, significantly fewer Xenical-treated patients progressed to type 2 diabetes compared to those on diet alone (9.8% vs 13.7%), a relative risk reduction of 36%.

Commenting on the results of the study, XENDOS co-principal study investigator Dr Jarl Torgerson said "Metabolic Syndrome is fast becoming the epidemic of the 21st century, with serious implications for cardiovascular disease in the future. These study results show that Xenical boosts the beneficial effects of weight loss in people with Metabolic Syndrome. Xenical, together with lifestyle changes, is a powerful approach to the effective management of this condition."

XENDOS was the first large-scale and longest clinical trial to assess the efficacy and safety of a weight loss medication (3304 patients over 4 years). It was also the first study of a weight loss medication to show a reduction in the risk of developing type 2 diabetes. These results are a significant step forward in showing that treatment with Xenical in combination with lifestyle modification is more effective than lifestyle intervention alone both in diabetes prevention and weight loss.

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Notes to Editors:

*ATP III Criteria4
Describes patients with 3 of the following criteria: high fasting glucose levels (>6.1 mmol/L), high waist measurement (>102 cm in men or >88 cm in women), low high density lipoprotein cholesterol (HDL, <1 mmol/L men or <1.3 mmol/L women), high triglyceride levels (>1.7 mmol/L) and high blood pressure (>130/85 mm Hg).

About Xenical
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 16.7 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: www.managingyourweight.com

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.

About Roche
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.

All trademarks used or mentioned in this release are legally protected.

For further information please contact:

Victoria West Shire Health International
Phone: 44-207-471-1543
Mobile: 44-781-505-2608
E-mail: victoria.west@shirehealthinternational.com

References:
1. 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.
2. Ford, E.S., Giles, W.H., Dietz, W.H. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA 2002; 287: 356-9.
3. Scottish Intercollegiate Guidelines Network: Clinical guidelines. Obesity in Scotland. Integrating prevention with weight management. November 1996.
4. Adult Treatment Panel III (ATP III) Criteria. National Cholesterol Education Programme – 3rd Report of the National Cholesterol Education Programme (NCEP). http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf


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