Public Release: 

Xenical® improves glycaemic control in those poorly controlled on anti-diabetic medication

Additional data shows post-prandial glucose benefits as well as the cost-effectiveness of Xenical treatment

Shire Health International

SAN FRANCISCO, June 17, 2002 - Treatment with the prescription weight-loss medication Xenical® (orlistat) provides additional glycaemic control benefits in overweight or obese patients with type 2 diabetes taking maximal or near-maximal doses of anti-diabetic medications, according to new data presented at the American Diabetes Association (ADA) in San Francisco1. Results were consistent regardless of the type of oral anti-diabetic treatment patients were receiving.

"These results are important for patients who are struggling to control their glucose levels without resorting to daily insulin injections," said Professor Stephan Jacob, M.D, medical director of the Albert Schweitzer Klinik, Königsfeld, Germany. "The findings suggest that weight loss with Xenical plus diet may provide physicians with another tool to control blood sugar in overweight or obese patients with type 2 diabetes, and prolong the utility of oral anti-diabetes medications."

This data should come as welcome news to physicians in their ongoing battle to control glucose levels in this difficult to treat patient group.

Study Outcomes
Researchers analysed data from seven double-blind, placebo-controlled trials of Xenical in overweight or obese patients with type 2 diabetes who were being treated with oral anti-diabetic medications. Patients were randomised to receive either Xenical 120 mg or placebo three times per day.

A sub-group of patients receiving maximal or near maximal doses of either metformin (³2000 mg) or sulfonylureas (³80% of standardised dose) was identified. This group was analysed to determine treatment effects on HbA1c levels and fasting plasma glucose (FPG) - both measures of glycaemic control. In the metformin group, researchers found that, compared to the placebo group, Xenical had a significantly greater impact on both HbA1c (-0.81% Xenical vs. -0.38% placebo) and FPG levels (-1.74 mmol/L Xenical vs. -0.38 mmol/L placebo). In patients treated with sulfonylureas, Xenical reduced HbA1c levels by -0.66% compared to -0.09% with placebo. Fasting plasma glucose was reduced -1.24 mmol/L by Xenical, versus an increase of +0.16 mmol/L for placebo.

Second Study Shows Post-Prandial Glucose Benefits
Additional data presented today showed treatment with Xenical has a statistically significant effect on post-prandial glucose (PPG) levels in overweight or obese patients with type 2 diabetes2.

At 24 weeks, Xenical-treated patients had significantly greater decreases in PPG levels compared to placebo recipients (-1.61 mmol/L vs. -0.10 mmol/L). At 52 weeks, PPG levels for Xenical-treated patients, on average, were -1.13 mmol/L. However, PPG levels actually increased for placebo-treated recipients (+0.36 mmol/L) at the 52-week point.

"These results demonstrate that Xenical, in combination with anti-diabetic agents and a mildly reduced-calorie diet, can have a significant impact on PPG levels," said Markolf Hanefeld, M.D, professor of internal medicine, Centre of Clinical Studies, Technical University, Dresden, Germany. "This is important because PPG levels are a strong indicator of how well a patient's blood sugar is being controlled."

Third Study Shows Xenical is a Cost-Effective Therapeutic Option
In addition, another study conducted by Assistant Professor Andreas Maetzel from the University of Toronto, Ontario, demonstrated that Xenical is cost-effective as adjunctive therapy to sulfonylureas, metformin or insulin in the management of overweight and obese patients with type 2 diabetes in the United States.

The cost-effectiveness ratio of Xenical was within the range considered acceptable, and was consistent with other chronic therapies.

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References
1. Jacob S et al. "Effect of orlistat on glycaemic control in patients on or near maximal doses of oral anti-diabetic (OAD) medications". Poster Presentation at American Diabetes Association (ADA) Meeting, San Francisco, 14-18 June 2002
2. Hanefeld M et al. "Effect of orlistat on post-prandial glucose levels in overweight or obese patients with type 2 diabetes". Poster Presentation at American Diabetes Association (ADA) Meeting, San Francisco, 14-18 June 2002

Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30 per cent and effectively promotes weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike appetite suppressants, it does not act on the brain. In clinical trials people taking Xenical in conjunction with a mildly reduced calorie diet have shown twice as much weight loss as diet alone. Since it was first marketed in 1998, there have been more than 13.2 million patient treatments with Xenical world-wide. Xenical is licensed for weight management 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 support 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-orientated healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well-being and quality of life.

Roche International Award for Obesity Journalism
The Roche International Award for Obesity Journalism is a new initiative to recognise excellence in overweight and obesity reporting. The awards are open to medical and consumer journalists from print, broadcast and electronic media. A prize of US$7,500 will be awarded for each winner in the medical and consumer journalism categories. For more information and submission details, please visit www.managingyourweight.com/formedia/formedia_ja.cfm or contact obesityjournalism@shirehealthinternational.com.

For further information please contact:
Antonia Betts
Shire Health International
Phone: +44 207 471 1525
E-mail: Antonia.Betts@shirehealthinternational.com

Liz Gofton
Shire Health International
Phone: +44 207 471 1518
E-mail: Liz.Gofton@shirehealthinternational.com

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