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Back To Vidyya New Indication For Xenical® Sought By Roche Pharmaceuticals

Xenical ® For Treatment Of Type 2 Diabetes?

Hoffmann-La Roche Inc. announced today that it has submitted a supplemental application to the U.S. Food and Drug Administration (FDA) for a new indication for its prescription weight loss medication Xenical® (orlistat) to improve glycemic control when used as an adjunct to other antidiabetic treatments in overweight or obese patients with type 2 diabetes.

Xenical, the only non-systemically acting prescription weight loss drug, is a gastrointestinal lipase inhibitor which prevents one-third of dietary fat from being absorbed. It received FDA approval in April 1999 for weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. If the new indication is approved, Xenical will be the only weight loss drug indicated for the treatment of type 2 diabetes.

The application for improved glycemic control in type 2 diabetics is supported by clinical trial data showing 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). Decreases in FPG were observed as early as after two weeks of treatment. In addition, patients with type 2 diabetes treated with Xenical were able to reduce their daily doses of other antidiabetic medications, such as sulfonylureas, insulin, and metformin.

"In controlled clinical trials, patients treated with Xenical experienced significant improvements in a number of cardiovascular risk factors such as total cholesterol, LDL cholesterol, LDL/HDL ratio and blood pressure in addition to their improvements in glycemic control and weight loss. It is clear that the benefits of Xenical extend beyond just weight loss," said Dr. Henry Solomon, medical director, Roche Pharmaceuticals. "The clinical trial data are exciting because they show that overweight patients with type 2 diabetes can improve their overall health, reduce their daily dose of diabetes medication, and control their symptoms with the addition of Xenical to their diabetes treatment regimen."

The new application is supported by findings from seven large multicenter, randomized, placebo-controlled trials involving 2,600 patients with type 2 diabetes. Four of the studies were one year in duration.

The clinical studies with Xenical in diabetes have shown:

  • -- Xenical patients had clinically significant improvements in blood sugar control

  • -- More patients treated with Xenical were able to reduce the dose of, or even discontinue their anti-diabetic medications

  • -- Overweight and obese patients with type 2 diabetes taking Xenical lost up to three times more weight than those on diet alone.

  • -- Additional data have also shown that Xenical can improve certain risk factors for cardiovascular disease, such as total cholesterol levels and blood pressure in diabetic patients.

Type 2 diabetes can lead to a host of severe complications, including heart disease, stroke, high blood pressure, blindness, kidney disease, nervous system damage, and amputation. Obesity is a primary risk factor for type 2 diabetes.

A recent study conducted by the Centers for Disease Control and Prevention (CDC) found that the incidence of type 2 diabetes among adults has increased rapidly throughout the 1990's across all regions and demographic groups. In addition, the prevalence of being severely overweight has increased 57 percent in the last decade, suggesting that further increases in the prevalence of type 2 diabetes can be expected.

Xenical is the only non-systemically acting prescription lipase inhibitor 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. Weight loss with Xenical has also resulted in improvements in many cardiovascular risk factors such as high blood pressure, high cholesterol, and diabetes, compared to diet alone. The long-term benefits of Xenical on weight-related illnesses and life expectancy have not been studied.

Xenical is unlike other weight loss medications because it is not an appetite suppressant. It is the most extensively studied pharmacological weight management treatment to date with more than 30,000 overweight or obese patients participating in clinical trials with Xenical.

Xenical patients are eligible to participate in XeniCare, a comprehensive weight-loss support program. Those participating in the program receive personal telephone counseling from a registered nurse or dietitian specially trained to provide weight-loss support. In addition, patients may receive ongoing information and resources designed to maximize their success.

Since 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.

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.

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Editor: Susan K. Boyer, RN
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