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Title: Weight Loss with Xenical (Orlistat) Reduces Threat of Developing Type 2 Diabetes

"Weight Loss with Xenical (Orlistat) Reduces Threat of Developing Type 2 Diabetes"

BASEL, SWITZERLAND -- December 23, 2003 -- According to results from the landmark XENDOS study published in Diabetes Care.1 patients who achieve weight loss with Xenical® (orlistat) have a significantly reduced risk of developing type 2 diabetes. This is the first time ever a weight loss medication has achieved this result. XENDOS is the largest and longest study to date of a weight loss medication, treating 3304 patients for 4 years with Xenical plus lifestyle changes, or lifestyle changes alone. It is also the first study to assess whether treatment with a weight loss medication, Xenical, can reduce the risk of developing type 2 diabetes. The study showed that losing weight with Xenical reduced the risk of developing diabetes by 37% compared with lifestyle changes alone and by 52% in patients with impaired glucose tolerance (IGT or pre-diabetes). Compared to lifestyle changes alone, Xenical treatment produced significantly greater long-term weight loss and improvements in cardiovascular risk factors (including blood pressure and lipids). The study also confirmed that Xenical has a long-term safety profile that is unmatched in the field of weight loss. Commenting on the study, Professor Lars Sjöström the XENDOS principal investigator said, "The XENDOS results represent a significant step forward in diabetes prevention, confirming that adding Xenical to lifestyle changes is a more effective strategy than lifestyle changes alone in delaying or preventing this deadly disease. This study provides hope for millions of overweight and obese people worldwide who are at risk of developing diabetes." Health experts have warned of a global epidemic of diabetes caused by a rise in overweight and obesity. There are currently 120-140 million people worldwide with type 2 diabetes, and if trends continue, this number is predicted to double in the next 25 years.2 More than 90% of all people with type 2 diabetes are overweight or obese.3 Study results showed: · During 4 years of treatment, Xenical plus lifestyle changes decreased the risk of developing diabetes by 37% over lifestyle changes alone. · Xenical reduced the progression to type 2 diabetes by 52% in patients with impaired glucose tolerance at baseline, compared to lifestyle changes alone. · Weight loss, both in the short and long-term, was significantly greater with Xenical (11.4kg vs. 7.5kg at one year and 6.9 vs. 4.1 kg at 4 years). Almost twice as many Xenical treated patients lost more than 10% body weight at the end of four years (26% vs. 16%). In addition, after 4 years over 52% of patients taking Xenical lost more than 5%body weight versus 37% in patients treated with lifestyle changes alone. · Xenical plus lifestyle changes resulted in early and significant improvements in cardiovascular risk factors that were sustained throughout the study, including blood pressure, waist circumference, and lipids (cholesterol). · Xenical was used safely over 4 years and was well-tolerated with more patients completing long-term treatment in the Xenical study group than those undertaking lifestyle changes alone. Type 2 diabetes Because of the severe health and cost implications of type 2 diabetes, organisations such as the International Diabetes Federation (IDF) have called for increased efforts to prevent the development of type 2 diabetes. The IDF estimates that 314 million people worldwide, or 8.2% of the global population, have impaired glucose tolerance, a state that often precedes type 2 diabetes.4 Excess weight Excess weight is well recognised as the most important modifiable risk factor for the development of type 2 diabetes. A number of recent studies have shown that lifestyle changes (diet and exercise) have a dramatic effect on delaying or preventing the development of type 2 diabetes.5, 6 The XENDOS study represents an important step forward in the evolution of diabetes prevention studies through the study design and the outcomes that were measured. All trademarks used or mentioned in this release are legally protected. References: 1. 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 2. World Health Organization. Health Topics. http://www.who.int/health_topics/diabetes_mellitus/en/ 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. International Diabetes Federation. New Diabetes Figures. http://www.idf.org/home/index.cfm?node=1054 5. Tuomilehto et al. Diabetes Prevention Study (DPS). NEJM, May 3, 2001, Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. 6. Diabetes Prevention Program (DPP). NEJM, February 7, 2002. Reduction in the incidence in type 2 diabetes with lifestyle intervention or metformin. SOURCE: Shire Health International

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