Orlistat (Xenical)

Xenical (orlistat)

• Class: Lipase inhibitor
• For: "People who are considerably overweight (at least 30 lbs, depending on height or have a BMI of 30 or greater). XENICAL is also for people who are overweight (at least 20 lbs, depending on height or have a BMI of 27 or greater) and also have other risk factors such as high blood pressure, high cholesterol, heart disease or diabetes. XENICAL should be taken with a reduced-calorie diet containing no more than 30% of calories from fat.
• Route of Administration: Oral
• Action: "Unlike other commonly prescribed weight-loss medications, XENICAL is not an appetite suppressant and does not affect your metabolism. Instead, it works in your digestive system to block about one-third of the fat in the food you eat from being digested."
• Marketed by: Roche Laboratories, Inc.
• Status: Approved in USA for obesity, and to delay of the onset of type 2 diabetes in obese patients with impaired glucose tolerance (IGT or pre-diabetes).
• Dose: "120 mg capsule by mouth with liquid at each main meal that contains fat. You can take XENICAL in conjunction with a mildly reduced-calorie diet up to 3 times a day."
• What it does: Encourages weight loss by inhibiting the absorption of dietary fats.
• Side Effects: "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." "Because XENICAL�(orlistat) has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin supplement containing fat-soluble vitamins once a day at least 2 hours before or after taking XENICAL�(orlistat)."

October 29, 2004 — 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) (see press release.).

FDA to review Roche's Xenical application for Type II diabetes treatment

Roche has received notification that the FDA has agreed to review its application to add a new indication to its prescription weight loss medication Xenical for the improvement of glycemic control in overweight or obese patients with Type II diabetes, when used in combination with other antidiabetic treatments. If the new indication receives final approval, Xenical will be the first weight loss drug indicated for the treatment of Type II diabetes.

Roche submitted the supplemental new drug application to the FDA on March 19, 2001, requesting approval of Xenical(R) (orlistat) for the treatment of diabetes based on the results of new clinical trials conducted in overweight and obese patients with Type II 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 glycosylated hemoglobin (HbA1c) and fasting plasma glucose (FPG).

Some of the favorable effects of Xenical treatment on glycemic control may be independent of weight loss, as decreases in FPG were observed as early as after two weeks of treatment -- before significant weight loss occurred. In addition, patients with Type II diabetes treated with Xenical were able to reduce their daily doses of other antidiabetic medications, such as sulfonylureas, insulin, and metformin. Finally, gastrointestinal side effects that occur in patients taking Xenical were observed less frequently in patients with Type II diabetes.

"The clinical trial data are exciting because overweight patients with Type II diabetes may be able to improve their overall health, reduce their daily dose of diabetes medication, and manage their symptoms with the addition of Xenical to their diabetes treatment regimen," said Dr Henry Solomon, medical director of Roche in a media release. "We expect the FDA will approve the new indication based on the strength of the data and the great potential to help people with Type II diabetes."

(From HealthcareMedia.com)