Xenical(R) Shown to Improve Control of Blood Glucose Levels In People With Type 2 Diabetes Beyond Impact of Weight Loss Alone

Xenical(R) Shown to Improve Control of Blood Glucose Levels In People With Type 2 Diabetes Beyond Impact of Weight Loss Alone

September 07, 2006

-- First Study to Demonstrate Independent Effect of Xenical on Glycaemic Control

    SYDNEY, Australia, Sept. 7 /Xinhua-PRNewswire/ -- The
weight loss medication Xenical(R) (orlistat) has been shown
to significantly reduce weight and improve the control of
glucose levels in the blood (glycaemia) beyond the impact
of weight loss alone in overweight and obese people with
type 2 diabetes, according to study results presented at
the International Congress on Obesity (ICO) in Sydney,
Australia.(1)  

    An analysis measuring the change in blood glucose
levels vs. weight at study end point confirmed that the
improvement in glycaemic control with Xenical was greater
than expected based on weight loss alone. This is the first
study to demonstrate Xenical's independent effect on
glycaemic control and it confirms that Xenical could play a
major role in the management and prevention of diabetes.
 
    More than one billion adults worldwide are now
overweight or obese and most suffer from weight-related
health problems.(2) One of the most common problems
associated with excess weight is type 2 diabetes. More than
90% of all people with type 2 diabetes are overweight, and
excess weight is well recognised as the most important
modifiable risk factor for the development of type 2
diabetes.(3) Unfortunately, many people with type 2
diabetes find it difficult to lose weight as their diabetes
medication can cause weight gain.

    "There is clear evidence to show that if weight is
controlled, type 2 diabetes can be prevented or
reversed," said Professor Stephan Jacob, Institute for
Cardiometabolic Preventive Medicine, Germany, and lead study
investigator. "Now we have additional grounds to
recommend Xenical -- not only does it reduce weight in
people with type 2 diabetes, but it independently improves
glycaemic control beyond the impact of weight loss
alone." 

    The study was an analysis of data from seven studies in
overweight / obese people with type 2 diabetes. Results
showed:(1)

    -- Weight loss was significantly greater with Xenical
vs. placebo (3.77 kg vs. 1.42 kg)

    -- In Xenical and placebo patients who experienced the
same minimal weight change, Xenical produced significantly
greater improvements in blood glucose levels (HbA1c levels
of -0.29% vs. +0.14%) and fasting plasma glucose
(-0.83mmol/L vs. +0.02 mmol/L) 

    Furthermore, in an additional study presented at ICO,
Xenical was shown to significantly improve blood pressure
in normotensive and hypertensive patients vs. placebo.(4)
Improvements were seen in both general practice and
hospital clinical settings. Xenical is the only available
weight loss medication to demonstrate this effect on blood
pressure.

    Notes to Editors:

    Study results

    Results of the study showing Xenical improves blood
pressure in both normotensive and hypertensive patients:(4)


    Normotensive patients:
 
    -- XENDOS study: SBP reduction 6.9 vs. 4.5 mmHg and DBP
reduction 3.4 vs. 2.1 mmHg

    -- X-PERT study (-500 and -1000 kcal/day restricted
diets): SBP reduction 6.0 mmHg both diet groups, DBP
reduction 2.6 and 3.8 mmHg respectively both diet groups

    -- XXL study: SBP reduction 5.9 mmHg and DBP reduction
3.3 mmHg Hypertensive patients:

    -- XENDOS study: SBP reduction 13.9 vs. 9.5 mmHg and
DBP reduction 9.0 vs. 6.7 mmHg

    -- X-PERT study (-500 and -1000 kcal/day restricted
diets): SBP reduction 17.1 and 19.0 mmHg respectively for
both diet groups, DBP reduction 8.9 and 10.9 mmHg
respectively for both diet groups

    -- XXL study: SBP reduction 12.9 mmHg and DBP reduction
7.6 mmHg

    About Xenical(R) (orlistat)

    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.(5) People
can lose up to twice as much weight with Xenical compared
to lifestyle changes alone.(6,7) Xenical also improves
cardiovascular risk factors, reduces the risk of developing
type 2 diabetes, and improves components of the metabolic
syndrome.(5,8) 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.(5) 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 25 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 a
supplier of innovative products and services for the early
detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of
medicines for cancer and transplantation and a market
leader in virology. In 2005 sales by the Pharmaceuticals
Division totalled 27.3 billion Swiss francs, and the
Diagnostics Division posted sales of 8.2 billion Swiss
francs. Roche employs roughly 70,000 people in 150
countries 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 ( http://www.roche.com ).

    References:

    1. Jacob S, Meier M, Rabbia M, Hauptman J. Orlistat has
positive effects on glycaemic control in type 2 diabetes
beyond improvements produced by weight loss alone. Poster
presented at the 10th International Congress on Obesity,
Sydney Australia.

    2. World Health Organization Web site (
http://www.who.int )

    3. 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. 

    4. Caterson I, Witter G. Orlistat markedly reduces
blood pressure in obese patients independently of clinical
setting - especially in those with baseline hypertension.
Poster presented at the 10th International Congress on
Obesity, Sydney Australia.

    5. 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

    6. 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.

    7. 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.

    8. 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 
     Shire Health International
     Tel:    [phone]
     Mobile: [phone]
     Email:  [e-mail]

     Dr. Paul King
     F. Hoffmann-La Roche Ltd, Basel, Switzerland
     Mobile: [phone]

SOURCE  Roche