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FDA Approves Labeling Showing Orlistat Delays Onset of Type 2 Diabetes
FDA Approves Labeling Showing Orlistat Delays Onset of Type 2 Diabetes -- Posted by Gumbo on 11-14-04 19:48
FDA Approves Labeling Showing Orlistat Delays Onset of Type 2 Diabetes
The Food and Drug Administration approved new labeling for Hoffmann-La Roche
Inc.s weight-loss drug orlistat (Xenical), which indicates the compound
delays the onset of type 2 diabetes in obese patients with impaired glucose
tolerance.
The label change makes [orlistat], the first weight loss medication to show
a reduction in the risk of developing type 2 diabetes, important news for
obese adults in the U.S. with impaired glucose tolerance, said Dr. Marc
Jacobson, of the North Shore-Long Island Jewish Health System, in a Roche
press release.
Approval of the new labeling was based on a 4-year study involving 3,304
obese patients with normal (n=2,643) or impaired glucose tolerance (nf1).
Results at 4 years showed orlistat reduced the relative risk of developing
type 2 diabetes by 42% in patients with impaired glucose tolerance as
compared with placebo. Orlistat did not reduce the risk among patients who
had normal glucose tolerance at baseline.
Furthermore, at 4 years, 21% of orlistat-treated patients had lost 10% of
their body weight or more and 45% had lost more than 5%, compared with 10%
and 28%, respectively, among placebo-treated patients.
Roche said this study marks the first time a weight-loss drug has been shown
to prevent or delay the onset of type 2 diabetes. This effect is believed to
be due to the weight loss itself rather than any independent effect of
orlistat on glucose or insulin metabolism, the company noted.
Orlistat was approved by the FDA in 1999 for use in conjunction with a
reduced-calorie diet for obesity management, including weight loss and
weight management, as well as to reduce the risk of weight regain following
weight loss.
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