FDA Approves Labeling That Xenical (Orlistat) Resulted in 42% Reduction in Risk

The first weight loss medication to show a reduction in the risk of developing type 2 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.

Reference:

(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.

SOURCE: Roche

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