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Xenical (Orlistat) Improves Post-prandial Glucose Levels in Obese Diabetics : Presented at ADA

By Jill Stein
Special to DG News

SAN FRANCISCO, CA -- June 16, 2002 -- The use of orlistat (Xenical®) in combination with anti-diabetic agents and a mildly decreased-calorie diet has a favorable effect on post-prandial glucose levels (PPG) in obese diabetic patients, researchers announced here Friday at the 62^nd Scientific Sessions of the American Diabetes Association (ADA).

Their data showed that at both six and 12 months, the beneficial effect of orlistat was significantly greater than that of anti-diabetic agents and a mildly reduced-calorie diet alone.

Dr. Markolf Hanefeld and associates at the Center for Clinical Studies in Dresden, Germany, conducted a retrospective analysis to evaluate the effect of orlistat on PPG levels in type 2 diabetic patients.

They assessed post-prandial glucose levels in three multicenter, double-blind studies in which overweight or obese patients (body mass index 28-43 kg/m²) with type 2 diabetes being treated with metformin and/or sulfonylurea were randomized to treatment with orlistat 120 mg or placebo three times daily plus a mildly reduced-calorie diet (500 to 600 kcal/d deficit).

These studies did not include patients who had undergone anti-diabetic treatment with a thiazolidinedione or insulin. One of the studies was one year in duration, the remainder were of six months duration.

The intent-to-treat (ITT) population included 452 patients who were randomized to double-blind treatment with orlistat and 431 randomized to placebo. The two groups had similar baseline body weight and glycemic control characteristics.

In all three studies, patients receiving orlistat had significantly greater least squares mean (LSM) decreases in body weight than those receiving placebo.

At week 24, orlistat-treated patients had significantly greater reductions in PPG glucose levels from baseline compared to those treated with placebo (-1.61 vs. -0.10 mmol/L).

The LSM difference from placebo for the orlistat-treated population was -1.26 mmol/L. At 52 weeks, PPG increased in placebo-treated patients (+0.36 mmol/L) but decreased in patients treated with orlistat (-1.13 mmol/L). The orlestat group had a LSM difference from placebo of -1.38 mmol/L. Patients treated with orlistat also had larger decreases in hemoglobin A1c levels than placebo recipients.

Dr. Hanefeld said that the effect of orlistat on PPG levels further demonstrates its beneficial effect on glycemic control, as shown by reductions in hemoglobin A1c and fasting plasma glucose levels in previous studies.

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