Good to Go?

May 22, the U.S. Food and Drug Administration announced that it will review the weight-loss drug orlistat (Xenical) to determine if it is a suitable treatment for type 2 diabetes. If given FDA approval, Xenical, which works by preventing about one-third of the fat in the food consumed from being absorbed, will be the first weight-loss drug indicated for the treatment of type 2 diabetes.

Xenical maker Roche submitted a supplemental new-drug application to the FDA on March 19, requesting approval of Xenical for the treatment of diabetes based on the results of new clinical trials conducted in overweight and obese patients with type 2 diabetes.

“The clinical trial data show that patients treated with Xenical plus a mildly reduced calorie diet lost more weight than those patients treated with placebo plus diet, and also had significantly greater and sustained decreases in (HbA1c) and fasting plasma glucose,” read a May 22 Roche statement. “In addition, patients with type 2 diabetes treated with Xenical were able to reduce their daily doses of sulfonylureas, insulin and [Glucophage].”

In seven large, multi-center, randomized, placebo-controlled trials involving 2,600 patients with type 2 diabetes, Xenical demonstrated:

  • clinically significant improvements in blood-sugar control
  • an ability to aid type 2s in reducing the dose of, or even discontinue, their anti-diabetic medications
  • a weight loss of up to three times more weight than diet alone in overweight and obese patients with type 2 diabetes
  • an improvement in certain risk factors for cardiovascular disease, such as total cholesterol levels and blood pressure.

In addition, Xenical’s notorious gastrointestinal side effects, which include gas with oily discharge and increased bowel movements—including an urgent need to have them and an inability to control them—occurred less often among Xenical patients with type 2 diabetes. Also, Xenical’s inhibiting effect on the absorption of some vitamins was also observed less frequently in people with type 2 diabetes.

Xenical received FDA approval for the treatment of obesity, including weight loss and weight management, in April 1999. The FDA also cleared Xenical for use in reducing the risk of regaining weight.

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