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

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

April 24, 2007

    BUDAPEST, Hungary, April 24 /Xinhua-PRNewswire/ -- 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 waist circumference (-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 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<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:
http://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 http://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
http://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 more information, please contact:

     Liz Gofton
     ShireHealthPR
     Tel:   [phone]
     Email: [e-mail] 

     Hanne Krog
     International Portfolio Business Manager, Xenical
     F. Hoffmann-La Roche Ltd.
     Tel:   [phone]
     Email: [e-mail]