ADA: Xenical (Orlistat) Helpful For Type 2 Diabetics With High A1c Levels

Orlistat (Xenical) has a beneficial effect on HbA1c levels, fasting plasma glucose and waist circumference in patients with baseline hemoglobin A1c (HbA1c) levels of 8 percent or greater.

The findings were reported at the annual meeting of the American Diabetes Association (ADA). ADA guidelines recommend a target HbA1c level of 7 percent and suggest medical intervention at eight percent or higher.

Jaime Davidson, MD, associate professor of medicine at the University of Texas Southwestern Medical School, in Dallas, Texas, United States, presented data on a pooled analysis of seven multicentre, double-blind trials, evaluated to study the effect of adjunctive orlistat treatment on glycaemic control in overweight or obese patients (BMI 28-43 kg/m˛) with Type 2 diabetes who also had a baseline HbA1c of 8 percent or greater.

The researchers in the seven studies randomized the subjects to treatment with orlistat 120 mg/day or placebo in addition to a mildly reduced-calorie diet (500-600 kcal/day deficit) and metformin, sulfonylurea and/or insulin treatment ongoing for no more than one year.

Mean baseline HbA1c level was approximately 9.3 percent. Intention-to-treat (ITT) analysis showed that at end point (24 or 52 weeks) there was a significantly (p<0.0001) greater decrease in HbA1c levels in the 728 patients treated with orlistat (0.99 percent) than in the 699 treated with placebo (0.52 percent).

A significantly higher proportion (p<0.0001) of orlistat-treated patients showed a decrease of at least 0.5 percent (63.9 percent) or at least 1 percent (49.0 percent) in HbA1c levels compared with placebo-treated patients (46.9 percent and 33.5 percent, respectively).

In the orlistat-treated population, mean fasting plasma glucose (FPG) level at baseline was approximately 11.40 mmol/L. At end point, ITT analysis indicated a significantly greater decrease (p<0.0001) in mean FPG levels with orlistat (1.83 mmol/L, n=769) than with placebo (0.75 mmol/L, n=752).

ITT analysis at end point also indicates a significantly greater decrease (p<0.0001) in mean waist circumference, which was approximately 110 cm at baseline, in the orlistat group (4.00 cm, n=685) than in the placebo group (2.02 cm, n=651).

"Orlistat, in combination with diet, represents a clinically beneficial adjunct to anti-diabetic therapy for overweight or obese patients with Type 2 diabetes who have inadequate glycemic control," the authors concluded.  American Diabetes Association's 62nd Annual Scientific Sessions