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Orlistat Found Beneficial in Type 2 Diabetics with Differing Hemoglobin A1c Levels: Presented at ADA

By Jill Stein
Special to DG News

SAN FRANCISCO, CA -- June 19, 2002 -- Orlistat used in conjunction with diet is a valuable adjunctive therapy in overweight and obese type 2 diabetics at all levels of glycemic control, researchers announced at the 62^nd Scientific Sessions of the American Diabetes Association (ADA).

Dr. Ralph De Fronzo, from the University of Texas Health Science Center in San Antonio, Texas, United States, presented the results of a retrospective analysis that examined the effect of orlistat on hemoglobin A1c (HbA1c) levels in patients with differing baseline HbA1c levels.

Data were pooled from seven multicenter, double-blind trials in which overweight or obese type 2 diabetics treated with metformin, sulfonylurea, and/or insulin were randomized to treatment with orlistat, 120 mg, or placebo, tid, in addition to a mildly reduced-calorie diet (500 to 600 kcal/d deficit) containing approximately 30 percent of calories as fat, for up to one year.

A total of 2,550 patients were randomized to treatment; 1,230 in the placebo group and 1,249 in the orlistat groups were eligible for intent-to-treat analysis.

Results showed that the weight loss from baseline was significantly greater for patients treated with orlistat than for those in the placebo group (-3.8 percent versus 1.4 percent, respectively). The least squares mean (LSM) difference between the two treatment groups was -2.4 kg.

In the whole intent-to-treat population, 1122 orlistat-treated patients had a significantly larger decrease in HbA1c than 1153 placebo recipients (-0.7 percent versus -0.3 percent). The LSM difference between the two treatment groups was -0.4 percent.

In all subpopulations of patients with differing baseline levels of hemoglobin A1c, ranging from 7 percent or greater to 11 percent or greater), those treated with orlistat had greater reductions in HbA1c from baseline to end point (week 24 or 52) than placebo recipients.

The LSM difference between the orlistat and the placebo groups for change in HbA1c level in patients with baseline level of 8 percent or greater was -0.5 percent. A significantly larger proportion of orlistat than placebo patients had reductions in HbA1c levels of 0.5 percent or greater from 8 percent or greater at baseline to less than 8 percent at end point (43.8 percent versus 27.8 percent).

Orlistat is a non-systemically acting lipase inhibitor that has been shown to have multiple benefits in trials in overweight patients with type 2 diabetes, including improving glycemic control, decreasing weight, and improving other risk factors for cardiovascular disease.

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