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New Data Show Xenical Significantly Reduces Cardiovascular Risk and More Than Doubles Weight Loss Achieved in Overweight and Obese People

BUDAPEST, April 24 /CNW/ - The weight loss medication Xenical (orlistat 120mg) significantly reduces weight and improves cardiovascular risk factors such as blood pressure, glycaemic control and lipid profile in overweight and obese people with type 2 diabetes and hypertension, according to a study analysis presented at the European Congress on Obesity (ECO), Budapest, Hungary.(1)

This analysis strengthens the wealth of data already established for Xenical that demonstrates that not only does it lead to significant weight loss, it also has remarkable benefits in reducing the risk of cardiovascular disease and diabetes, two of the world's most serious health conditions. According to the World Health Organisation (WHO), around 1.6 billion adults worldwide are overweight, and at least 400 million adults are obese.(2) Excess weight is associated with a number of life-threatening health consequences, including:

- Cardiovascular disease - the world's number one cause of death, killing 17 million people each year.(2) Hypertension is a major risk factor for cardiovascular disease.(3)

- Diabetes - nine of every 10 people with type 2 diabetes are overweight.(4) WHO projects that diabetes deaths will increase by more than 50% worldwide in the next 10 years(5)

"We know that the incidence of type 2 diabetes and hypertension rises steeply with increasing body weight," said Professor Iain Broom, Department of Clinical Biochemistry and Metabolic Medicine, Grampian University Hospitals NHS Trust, UK and study lead. "These results support the use of Xenical to achieve substantial weight loss, and to improve cardiovascular health and manage independent risk factors in overweight and obese people." The study analysis involved 2,692 overweight and obese people. Patients with high cardiovascular risk (type 2 diabetes and hypertension), and treated with Xenical vs. placebo demonstrated significant improvements in:

- Blood pressure (SBP: -6.45 mmHg vs. -3.47 mmHg, p(less than)0.01; DBP: -4.31 mmHg vs. -3.11 mmHg, p=NS). 15.3% of patients treated with Xenical returned to normal blood pressure vs. 8.7% receiving placebo (p(less than)0.05)

- Blood glucose levels - HbA1c (-0.41% vs. -0.03%, p(less than)0.0001)

- Insulin (-25.02 pmol/l vs. -14.17 pmol/l, p(less than)0.01)

- Fasting glucose (-1.23 mmol/l vs. -0.38mmol/l, p(less than)0.0001)

- Total cholesterol (-4.19% vs. 0.77%, p(less than)0.0001) and LDL cholesterol (-7.32% vs. 1.98%, p(less than)0.0001) >>

Xenical patients more than doubled their weight loss vs. placebo (-4.83kg vs. -1.49kg, p(less than)0.0001), which was also reflected in reduced waist circumference (-5.20cm vs. -1.98cm, p(less than)0.0001). In patients who responded early to treatment (greater than or equal to 5% weight loss at 3 months)(X), Xenical produced even greater changes in blood pressure (SBP/DBP: -13.16/-7.83 mmHg), HbA1c (-0.84%), insulin (-38.72 pmol/l), fasting glucose (-1.92 mmol/l) and weight (-9.61kg) vs. placebo. Blood pressure normalisation was more than two-fold greater with Xenical vs. placebo (24.2% vs. 10.5%). Data from two additional study analyses presented at ECO also confirm Xenical's role in reducing cardiovascular risk:

- Obese patients with hypertension who responded early to treatment with Xenical experienced greater reductions in weight, waist circumference and lipid levels vs. placebo. 48% of patients treated with Xenical returned to normal blood pressure levels vs. 40.2% of placebo patients(6).

- Xenical was also shown to improve risks associated with the metabolic syndrome (based on NCEP ATP III criteria). Of particular note was the large improvement in LDL cholesterol with Xenical vs. placebo after one year (-7.5% vs. 5.3%, p(less than)0.0001)(7) >>

Notes to Editors:

(X)= Xenical European label

About Xenical(R) (orlistat 120 mg)

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 28 million patient treatments world-wide. Xenical is licensed for use 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 one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References:

1. Broom I, Guy-Grand B, Hill J. Orlistat treatment significantly improves blood pressure, glycaemic control and lipid profile in obese/overweight patients with type 2 diabetes and hypertension. Poster presented at the 15th European Congress on Obesity, Budapest, Hungary.

2. World Health Organisation Fact Sheet No 311 - Obesity and overweight. September 2006. Last accessed online 28 March 2007 at http://www.who.int/mediacentre/factsheets/fs311/en/print.html

3. WHO/ISH Hypertension guidelines. Last accessed 28 March 2007 at www.who.int/cardiovascular_diseases/guidelines/hypertension/en/print.html

4. Colditz GA, Willett WC, Rotnitzky A, Manson JE. "Weight gain as a risk factor for clinical diabetes mellitus in women". Ann Inter Med (1995). 122: 481-486.

5. World Health Organisation Fact Sheet No 312 - Diabetes. September 2006. Last accessed online 28 March 2007 at http://www.who.int/mediacentre/factsheets/fs312/en/print.html

6. Jacob S, Boldrin M, Hauptman J. Early weight loss response with orlistat in hypertensive obese patients predicts improvements in blood pressure and lipid profile. Poster presented at the 15th European Congress on Obesity, Budapest, Hungary.

7. Ziegler O, Laville M, Basdevant A. Orlistat in non-elderly patients with metabolic syndrome (MS) - meta-analysis shows early response patients have significant improvements in MS criteria. Poster presented at the 15th European Congress on Obesity, Budapest, Hungary.

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. >>

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/For further information: Liz Gofton, ShireHealthPR, Phone: +44-(0)-207-108-6518, E-mail: hanne_greta.krog@roche.com

Posted: April 2007

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