New Data Show Xenical(R) 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(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(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.
    





For further information:

For further information: Liz Gofton, ShireHealthPR, Phone:
+44-(0)-207-108-6518, E-mail: liz.gofton@shirehealthinternational.com; Hanne
Krog, International Portfolio Business Manager, Xenical, F. Hoffmann-La Roche
Ltd., Phone: +41-(0)-616881695, E-mail: hanne_greta.krog@roche.com

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