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Xenical (Orlistat) Helps Maximally-Medicated Diabetics Avoid Insulin: Presented at ADA

By Bruce Sylvester
Special to DG News

SAN FRANCISCO, CA -- June 17, 2002 -- Orlistat (Xenical®) provides additional glycemic control in patients with type 2 diabetes who are not stabilized with maximal or near-maximal doses of anti-diabetes medications -- and might help them avoid going on insulin, researchers reported at annual meeting of the American Diabetes Association (ADA).

"The findings suggest that weight loss with Xenical plus diet may provide physicians with another tool to control blood sugar in overweight or obese patients with type 2 diabetes, and prolong the utility of oral anti-diabetes medications," said lead researcher Stephan Jacob, MD, medical director of the Albert Schweitzer Klinic in Konigsfeld, Germany.

Investigators analyzed pooled data from seven double-blind, placebo-controlled studies of orlistat treatment in overweight or obese patients with type 2 diabetes who were taking oral anti-diabetes (OAD) medications.

Subjects had been randomized to receive either orlistat 120 mg three times per day with meals or placebo. All subjects ate a reduced calorie diet (lowered 500-600 calories per day).

The researchers identified a subgroup of subjects who were taking maximal or near maximal doses of either metformin (2000 mg or greater) or sulfonylureas (80 percent or greater of standardized dose). After up to one year of treatment, they analyzed the data on these subjects with special regard to effects on hemoglobin A1c (HbA1c) levels and fasting plasma glucose (FPG), both indicators of glycemic control.

In the metformin-user group, compared to the placebo-plus-diet group, orlistat-plus-diet had a greater impact on HbA1c (-0.81 percent orlistat vs.-38 percent placebo) and on FPG levels (-1.74 mmol/L orlistat vs. -0.38 mmol/L placebo). In patients treated with sulfonylureas, orlistat-plus-diet lowered HbA1c levels by -0.66 percent compared to -0.09 percent for placebo-plus-diet. Fasting plasma glucose fell by -1.24 mmol/L with orlistat versus an increase of +0.16 mmol/L with placebo.

"In patients on maximal or near maximal doses of OADs, orlistat provides additional improvements in glycemic control," the authors concluded. "The beneficial effect of orlistat on HbA1c and FPG in patients receiving maximal or near maximal doses of metformin or sulfonylureas is similar to that seen in the overall treatment group."

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