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Landmark XENDOS Study Shows Xenical (Orlistat) Significantly Prevents Or Delays The Development Of Type 2 Diabetes

MISSISSAUGA, ON -- August 26, 2002 -- Roche announced today that the results of the four year landmark XENDOS study involving 3,304 patients demonstrated that the weight loss medication Xenical (orlistat) can significantly prevent or delay the development of type 2 diabetes. Furthermore, the XENDOS study data showed significant and sustained weight loss over the long term⁽¹⁾.

"The XENDOS study is most welcome as it demonstrates scientifically that Xenical is an excellent choice as a treatment option for overweight or obese patients who have made a commitment to healthy eating and physical activity, but need additional assistance with weight management. In fact, a five to 10 per cent weight reduction has been shown to have clear health benefits," said Dr. Liam Murphy from the University of Manitoba in Winnipeg.

"The use of Xenical with overweight or obese type 2 diabetes patients has already been clearly shown to address one of the core issues associated with diabetes - excess weight. Weight reduction may improve blood sugar control and may also reduce or eliminate the need for additional antidiabetic medications," he added.

"The outstanding XENDOS study results show that Xenical has a key role in combating the diabetes epidemic. Diabetes is a dangerous and expensive complication of obesity. An effective and safe drug that helps to prevent or delay the disease, as well as to maintain weight loss over the long term, is of real value for millions of overweight people at risk of developing diabetes," said William M. Burns, head of the pharmaceutical division at Roche.

XENDOS study results showed that:

- Xenical plus lifestyle intervention is significantly better than lifestyle intervention alone in preventing or delaying the development of type 2 diabetes.
- The risk of developing type 2 diabetes was 37 per cent lower in people treated with Xenical plus lifestyle intervention compared with lifestyle intervention alone.
- Weight loss, both in the short and the long term, was significantly greater with Xenical plus lifestyle intervention compared with lifestyle intervention alone (-11.4 vs. -7.5 kg at one year and -6.9 vs. -4.1kg at four years).
- Weight loss was successfully maintained in the long-term, with almost twice as many Xenical treated patients losing more than 10 per cent body weight at the end of four years of treatment (26 per cent vs. 16 per cent). Even more patients had lost more than 5 per cent body weight after four years (53 per cent vs. 37 per cent), an amount that has been shown to have clear health benefits.
- Xenical-treated patients had significant, sustained, long-term improvements in cardiovascular risk factors such as blood pressure and lipid profiles compared with lifestyle intervention alone.
- Treatment with Xenical for four years was safe and well tolerated. Xenical is now the only weight loss medication available whose safety has been studied for this length of time.

Diabetes in Canada
Approximately 90 per cent of the more than 2 million people in Canada with diabetes have type 2 diabetes. Eighty to 90 per cent of these patients are overweight or obese, and weight is the most significant modifiable risk factor in patients with type 2 diabetes. It is estimated that diabetes cost the Canadian healthcare system close to $9 billion (CAD) every year for treatment of the disease and its associated complications.

"The Canadian Diabetes Association welcomes any new treatment options that may assist someone with diabetes to manage the disease and/or related complications. This is especially important given that the prevalence of diabetes in Canada, specifically type 2 diabetes, is expected to double over the next decade," said Donna Lillie, Director, Research and Professional Education, Canadian Diabetes Association.

"The Canadian Diabetes Association encourages individuals with diabetes or at risk for diabetes to discuss any new treatment option with their physician to determine the appropriateness of particular treatments to their individual situation," she said.

Excess weight
Excess weight is well recognized as the most important modifiable risk factor for the development of type 2 diabetes. A number of recent studies have shown that lifestyle intervention (to reduce weight and increase physical activity) has a dramatic effect on delaying or preventing the development of type 2 diabetes⁽²⁾,⁽³⁾. As a result of these findings, authorities currently recommend lifestyle intervention as the most effective treatment approach to preventing type 2 diabetes, particularly as there are additional health benefits such as reduced blood pressure, reduced cholesterol levels and improved quality of life.⁽⁴⁾

About Xenical
Xenical has been available in Canada since June, 1999. It is an effective and safe prescription therapy that not only helps patients lose weight, but also helps them maintain their weight loss. It is the only available weight loss medication that works locally in the gut to prevent the absorption of dietary fat by about 30 per cent. Xenical is well tolerated, and unlike other prescription weight loss medications, it does not act on the central nervous system, which can increase blood pressure or heart rate. In clinical trials, people taking Xenical in conjunction with a mildly reduced calorie diet have shown twice as much weight loss as diet alone. Xenical is covered by a number of private insurance companies as a viable and effective treatment option available to assist people in losing weight and has also been submitted for provincial coverage across Canada.

Xenical (orlistat) has been approved by Health Canada for use in combination with antidiabetic agents to improve blood glucose control in overweight or obese type 2 diabetes patients. Xenical is the first weight management drug to receive this approval from Health Canada.

In addition, the BodyWellness Support Program(TM) provides Xenical patients with access to a registered dietitian and a personalized weight-loss program to help them achieve their weight-loss targets. Based on a three-step approach, including a healthy lifestyle, patient support and treatment with Xenical, the program is designed to help patients learn to manage their weight by making specific lifestyle changes.

Roche International Award for Obesity Journalism
The Roche International Award for Obesity Journalism is a new initiative to recognize excellence in overweight and obesity reporting. For more information and submission details, please visit www.managingyourweight.com/formedia/formedia_ja.cfm or contact obesityjournalism@shirehealthinternational.com.

About Hoffmann-La Roche Limited
Hoffmann-La Roche Limited is a healthcare company committed to the discovery and development of new and innovative medicines to help treat human illnesses. The company is active in a broad range of therapeutic categories that include AIDS, cardiology, dermatology, hepatitis C, infectious disease, metabolism, transplant, oncology and virology.

All trademarks used or mentioned in this release are legally protected.


References:
1. Sjostrom L. et al "XENDOS (XENical in the prevention of Diabetes in Obese Subjects): A Landmark Study". Poster presented at ICO, Sao Paulo, 2002.
2. Diabetes Prevention Study (DPS). NEJM, May 3, 2001, Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. Tuomilehto et al
3. Diabetes Prevention Program (DPP). NEJM, February 7, 2002. Reduction in the incidence in type 2 diabetes with lifestyle intervention or metformin
4. American Diabetes Association and National Institute of Diabetes, Digestive and Kidney Diseases position statement. Diabetes Care, Vol 25, Number 4, April 2002. The prevention or delay of type 2 diabetes. Sherwin et al


SOURCE: Hoffmann-La Roche

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