First study to demonstrate independent effect of Xenical on glycaemic control
SYDNEY, AUSTRALIA -- September 7, 2006 -- The weight loss medication Xenical® (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.
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® (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.
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.
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 (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.
SOURCE: Roche
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