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FDA Approves Labeling Showing Xenical(R) (Orlistat) Treatment Resulted in 42% Reduction in Relative Risk of Developing Type 2 Diabetes

Posted on: Friday, 29 October 2004, 12:00 CDT

NUTLEY, N.J., Oct. 29 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration (FDA) has approved labeling showing that weight loss with Xenical(R) (orlistat) delayed the onset of type 2 diabetes in obese patients with impaired glucose tolerance (IGT or pre-diabetes).

The label change is based on results from the XENDOS (Xenical in the Prevention of Diabetes in Obese Subjects) study, the largest and longest study to date of a weight loss medication. XENDOS assessed the delay in onset of diabetes and weight loss in 3304 obese patients (BMI greater than or equal to 30) with either normal (n=2643) or impaired glucose tolerance (n=661) in a four-year, double-blind, placebo-controlled study. Data showed a 42% (p<0.01) relative risk reduction for developing type 2 diabetes among obese patients treated with Xenical who had impaired glucose tolerance at baseline compared to placebo(1). Xenical did not reduce the risk for developing type 2 diabetes among obese patients with normal glucose tolerance at baseline. The XENDOS findings mark the first time that treatment with a weight-loss medication has been shown to prevent or delay the onset of type 2 diabetes. This effect is believed to be due to the additional weight loss that occurs with Xenical treatment, rather than any independent effects of Xenical on glucose or insulin metabolism.

"The label change makes Xenical the first weight loss medication to show a reduction in the risk of developing type 2 diabetes, important news for obese adults in the U.S. with impaired glucose tolerance," said Marc S. Jacobson, M.D., attending physician at North Shore-Long Island Jewish Health System. "Since the prevalence of obesity, a primary risk factor for type 2 diabetes, has increased 57% in the last decade, as has the prevalence of type 2 diabetes, any new weaponry in our arsenal against this deadly disease is important."

About Weight Loss in the XENDOS Study

* Weight loss, both in the short and long-term, was significantly greater

with Xenical than placebo (25.13 lbs. vs. 16.53 lbs.) at one year and

(15.21 lbs. vs. 9.04 lbs.) at four years. Following the first year of

treatment, almost twice as many Xenical treated patients lost more than

10% body weight (41% vs. 21%), and 73% of patients taking Xenical lost

more than 5% body weight versus 45% in patients treated with placebo and

lifestyle changes alone. At the end of four years, twice as many

Xenical-treated patients lost more than 10% of their body weight (21% vs

10%) and 45% of the patients taking Xenical lost more than 5% of their

body weight compared to 28% of the placebo-treated patients.

* Xenical plus lifestyles 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 has not been shown to change

cardiovascular outcomes, however.

* Xenical was used safely over four years with more patients completing

long-term treatment in the Xenical study group than those undertaking

lifestyle changes alone.

Type 2 Diabetes

An estimated 15.7 million adults in the United States (8% of men and women age 20 or older) have diabetes, with type 2 diabetes accounting for about 90% to 95% of cases. The prevalence of obesity, a primary risk factor for type 2 diabetes, has increased 57% in the last decade, as has the prevalence of type 2 diabetes. There are currently approximately 160 million people worldwide with type 2 diabetes, and if trends continue, this number is predicted to double in about 25 years. More than 90% of all people with type 2 diabetes are overweight or obese.

Pre-diabetes is a term used to distinguish people who are at increased risk of developing diabetes. People are considered to have pre-diabetes if they have impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT). The American Diabetes Association estimates that about 16 million U.S. adults ages 40 to 74 have IGT and 35 million have IFG.

About Xenical

Xenical is indicated for obesity management including weight loss and weight management when used in conjunction with a reduced-calorie diet. Xenical is also indicated to reduce the risk for weight regain after prior weight loss. Xenical is the only available weight-loss medication that works locally in the GI tract to reduce dietary fat absorption by around 30% which effectively promotes weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. The medication is approved for weight management in over 140 countries around the world.

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 oily spotting or discharge, gas with discharge, fatty or oily stools, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended. 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 strongly recommended. For more information about Xenical visit the web site at http://www.xenical.com/

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com/

(1) The percent of patients with impaired glucose tolerance (IGT) who

developed type 2 diabetes was 27.2% for the placebo group (n=62)

compared to 18.7% for the orlistat group (n=48) resulting in an

absolute risk reduction of 8.5% and a relative risk reduction of 42%;

see Xenical prescribing information.

Roche

CONTACT: Terence Hurley of Roche, +1-973-562-2882,terence_j.hurley@roche.com; or Bob Brody of Ogilvy Public Relations Worldwide,+1-212-880-5248, bob.brody@ogilvypr.com, for Roche

Web site: http://www.xenical.com/http://www.rocheusa.com/

Source: PRNewswire

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