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

BUDAPEST--24 Apr--PRNewswire-AsiaNet/InfoQuest


The weight loss medication Xenical(R) (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<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<0.05)

-- Blood glucose levels - HbA1c (-0.41% vs. -0.03%, p<0.0001)
-- Insulin (-25.02 pmol/l vs. -14.17 pmol/l, p<0.01)
-- Fasting glucose (-1.23 mmol/l vs. -0.38mmol/l, p<0.0001)
-- Total cholesterol (-4.19% vs. 0.77%, p<0.0001) and LDL cholesterol (-

7.32% vs. 1.98%, p<0.0001)

Xenical patients more than doubled their weight loss vs. placebo (-4.83kg vs. -1.49kg, p<0.0001), which was also reflected in reduced waistcircumference (-5.20cm vs. -1.98cm, p<0.0001).

In patients who responded early to treatment (>/= 5% weight loss at 3 months)*, 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 normalisationwas 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<0.0001)(7)

Notes to Editors:

* = 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.

SOURCE Roche

CONTACT: Liz Gofton of ShireHealthPR,

+44 (0) 207 108 6518, or

[email protected] , or

Hanne Krog, International Portfolio Business Manager,

Xenical, of F. Hoffmann-La Roche Ltd.,

+41 (0)616881695, or

[email protected]/

Web site: http://www.managingyourweight.com

http://www.roche.com /

--Distributed by AsiaNet ( www.asianetnews.net )--


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