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Orlistat Reduces Type 2 Diabetes in High-Risk Obese Patients: Presented at ADA
By Jill Stein
NEW ORLEANS, LA -- June 16, 2003 -- Treatment with orlistat in conjunction with lifestyle changes decreases the rate of type 2 diabetes in obese patients with impaired glucose tolerance (IGT) or metabolic syndrome.
These results were reported here on June 14th at the 63rd Scientific Sessions of the American Diabetes Association.
Ralph DeFronzo, MD, from University of Texas Health Science Center, in San Antonio, United States, led a team that studied the effects of orlistat on the onset of type 2 diabetes in patients with IGT or metabolic syndrome, enrolled in the Xenical in the prevention of Diabetes in Obese Subjects (XENDOS) study.
The XENDOS study is a 4-year, prospective, randomized, double-blind trial in which 3,304 obese Swedish patients with normal glucose tolerance (79%) or IGT (21%) received 3 times daily dosing of orlistat 120 mg or placebo in combination with lifestyle changes.
The diagnosis of metabolic syndrome was established on the basis of the Adult Treatment Panel III criteria, and type 2 diabetes was diagnosed on the basis of a single 2-hour oral glucose tolerance test (OGTT) and whole-blood glucose measurement greater than or equal to 10.0 mmol/L.
After 4 years of treatment, and in all patients, orlistat significantly decreased the progression to type 2 diabetes compared to placebo. The hazard ratio (0.627) corresponded to a 37.3% decrease in the risk of developing diabetes in patients receiving orlistat compared with placebo.
Treatment with orlistat also decreased the risk of progression to type 2 diabetes by 45% compared with placebo in patients with IGT at baseline, irrespective of metabolic syndrome status.
In patients with baseline normal glucose tolerance, the rate of progression to type 2 diabetes was low in both the orlistat and placebo groups.
Results also showed that orlistat treatment greatly decreased the progression to type 2 diabetes compared with placebo in patients with and without metabolic syndrome, with a reduction of 36% and 40%, respectively.
"The study is the first ever to show that a weight-loss medication can prevent or postpone the onset of type 2 diabetes in at-risk patients," Dr. DeFronzo concluded.
This study was supported by Hoffmann-La Roche of Nutley, New Jersey.
[Study title: XENDOS: Onset of Type 2 Diabetes in Obese Patients with Normal Glucose Tolerance/IGT and Metabolic Syndrome. Abstract 1706]
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