Data Show Xenical Improves Glucose And Lipid Levels In Diabetics

August 3, 1998
DALLAS, TX

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Anti-obesity drug therapy with Hoffmann-La Roche's Xenical (orlistat) prevents the progression of Type II diabetes in obese patients with elevated glucose levels and can potentially eliminate the need for sulfonylurea (hypoglycemic) therapy, according to a new study published in the current issue of Diabetes Care.

The study showed that in addition to achieving clinically meaningful weight loss and maintenance of weight loss, patients taking orlistat also showed improved LDL/HDL ratios and total cholesterol and triglyceride levels for up to one year. Furthermore, almost half of orlistat treated patients were able to decrease their average dose of oral sulfonylurea medication compared with less than a third of placebo-treated patients.

"This study is significant because it shows that Xenical not only promotes weight loss but also improves glycemic control and lowers sulfonylurea dose requirements in patients with type II diabetes," said Priscilla Hollander, M.D., Ph.D., medical director, Baylor-Ruth Collins Diabetes Center, at Baylor University Medical Center in Dallas, the study's lead investigator. "Xenical also demonstrates a beneficial effect on lipids independent of what we would expect from weight loss alone. This may be related to Xenical's mechanism of action, which reduces the absorption of dietary fat."

Xenical represents an entirely new class of drugs called lipase inhibitors that act locally in the gastrointestinal tract to prevent the absorption of a portion of dietary fat. This randomised, placebo-controlled, multi-centre trial was conducted at 12 prominent research centres in the U.S. A total of 391 obese men and women with type II diabetes being treated with oral sulfonylureas were given 120 mg of orlistat or placebo three times a day and followed a mildly hypocaloric diet for one year.

Results indicate that more than twice as many patients in the Xenical group lost five percent of initial body weight as compared to patients in the placebo group. Furthermore, compared to placebo plus diet modification, patients receiving orlistat in conjunction with diet modification showed significant improvements in glycemic control and were able to decrease their dosage of oral sulfonylurea medication. Xenical treatment also resulted in significantly greater improvements than placebo in several lipid parameters.

"While weight loss is almost always recommended as first line therapy for Type II diabetes, it is very difficult to achieve and maintain weight loss in patients on sulfonylurea medications since these therapies tend to promote weight gain," Dr. Hollander said. "Unfortunately, current approaches to weight loss have been ineffective in promoting long-term weight loss and improving glycemic control. Orlistat is the first pharmacotherapy to be studied in a long-term, large-scale study in obese patients with Type II diabetes and it shows great promise for this patient population."

The study's authors' point out that while a number of other pharmacologic agents have been used in obese patients to promote weight loss, most of these drugs act on the central nervous system to suppress appetite. As a result, in patients with Type II diabetes, the use of these drugs is strictly regulated.

Obese individuals have a three times greater risk of developing Type II diabetes and, of the estimated 15 million Americans who have the disease, up to 80 percent are overweight or obese. Left untreated in patients with Type II diabetes, obesity can lead to many serious and potentially life-threatening conditions including heart disease, stroke, kidney failure, impotence, blindness and nerve damage.