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WEIGHT LOSS WITH XENICAL SHOWN TO SIGNIFICANTLY PREVENT OR DELAY ONSET OF TYPE 2 DIABETES IN OBESE PATIENTS, ACCORDING TO NEW FOUR-YEAR XENDOS STUDYRisk of developing type 2 diabetes 37 percent lower in people treated with Xenical plus diet and lifestyle intervention versus diet and lifestyle intervention alone.Xenical (orlistat) plus diet and changes in lifestyle habits significantly prevented obese patients from developing type 2 diabetes, according to a major four-year clinical study presented at the 9th International Congress on Obesity in Sao Paulo, Brazil. This is the first time that a weight loss medication was shown to prevent or delay the onset of type 2 diabetes in an at-risk patient population. The XENDOS trial studied 3,304 obese Swedish patients over a four-year period who were randomized into two trial arms: Xenical plus diet and lifestyle intervention and placebo plus diet and lifestyle intervention alone. XENDOS also is the first large-scale and longest study to examine the efficacy and safety of a weight loss medication. XENDOS Results
"Against the background of several studies that show lifestyle intervention in the prevention of diabetes to be successful, it is a significant step forward to be able to show that treatment with Xenical plus diet in combination with lifestyle modification is more effective than diet and lifestyle intervention alone in both diabetes prevention and weight loss," said Professor Lars Sjöström, Sahlgrenska University Hospital, Gothenburg, Sweden, principal investigator of the XENDOS study.
Study Design The four-year XENDOS study was a multi-center, randomized, double-blind, placebo-controlled, parallel-group, prospective study performed at 22 centers in Sweden. Obese patients (Body Mass Index ³ 30) aged 30-60 years with normal or impaired glucose tolerance were eligible for inclusion in the study. Patients were randomized to treatment with Xenical (120mg) plus diet or placebo plus diet three times daily, together with lifestyle intervention consisting of a mildly reduced-calorie diet (800kcal/day deficit) and moderate physical exercise for up to four years. Type 2 Diabetes An estimated 15.7 million adults in the U.S. (8 percent of men and women age 20 or older) have diabetes, with type 2 diabetes accounting for about 90 to 95 percent of these cases.1 The prevalence of obesity, a primary risk factor for type 2 diabetes, has increased 57 percent in the last decade, suggesting that further increases in the prevalence of type 2 diabetes can be expected. 2 Worldwide, the prevalence of overweight and obesity is growing at an epidemic rate, with a corresponding surge in the incidence of type 2 diabetes. It is estimated that there are at least 150 million people in the world with diabetes and that type 2 diabetes accounts for 90 per cent of all cases. This figure is expected to double over the next 25 years. 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.3,4 As a result of these findings, authorities currently recommend lifestyle intervention as the most effective treatment approach to preventing type 2 diabetes, particularly because it provides additional health benefits such as reduced blood pressure, reduced cholesterol levels and improved quality of life.5 About Xenical Approved in April 1999 for weight loss, maintenance of lost weight, and the reduction of risk of weight regain after prior weight loss when used with a reduced-calorie diet, Xenical is the only non-systemically acting gastrointestinal lipase inhibitor. Its mechanism of action is to prevent one-third of dietary fat from being absorbed. Weight loss with Xenical also has resulted in improvements in many cardiovascular risk factors such as high blood pressure, high cholesterol and diabetes, compared with diet alone. Xenical has an established safety profile and is the most extensively studied weight management treatment to date. Xenical has been used in two million patients worldwide. The long-term effects of Xenical on morbidity and mortality associated with obesity have not been established. Because Xenical prevents about one-third of the fat in the food consumed from being absorbed, patients may experience gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended. In clinical trials, these effects appear to occur less often among Xenical patients with type 2 diabetes than in patients treated for obesity. Xenical should not be taken if patients are pregnant, nursing, have food absorption problems or reduced bile flow. If taking cyclosporine, patients should speak to their doctors before taking Xenical. Xenical reduces the absorption of some vitamins. Therefore, a daily multivitamin is recommended. References:
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