Xenical May Cut Type 2 Diabetes Risk
Diet Drug Safe, Maintains Weight Loss During 4-Year Study
Dec. 23, 2003 -- The diet drug Xenical -- combined with lifestyle changes -- helps prevent type 2 diabetes, a new study shows.
But the drug doesn't work all by itself. But when combined with regular exercise and a low-fat, reduced-calorie diet, the drug helps people lose more weight then they would through exercise and diet alone.
More importantly, the drug cut the risk of diabetes by 37%. Most of this effect was because of diabetes prevention in people with impaired glucose tolerance. Impaired glucose tolerance, or IGT, is one of the early signs of the metabolic meltdown leading to diabetes.
"[These] results represent a significant step forward in diabetes prevention, confirming that adding Xenical to lifestyle changes is a more effective strategy than lifestyle changes alone in delaying or preventing this deadly disease," researcher Lars Sjöström says in a news release from Roche, the company that makes Xenical.
The findings appear in the January issue of Diabetes Care.
An Extra 6-Pound Weight Loss With Xenical
All of the 3,300 men and women in the Roche-sponsored study were obese, with an average weight of about 224 pounds and an average age of about 43 years. At the beginning of the study, about one in five already had impaired glucose tolerance.
Everybody in the study underwent "lifestyle changes." In this study, that meant a reduced-calorie diet with no more than 30% of calories from fat and not more than 300 milligrams of cholesterol per day. It also meant dietary counseling every two weeks for six months, with monthly counseling sessions for the next three and a half years. Everyone was encouraged to add at least a half mile of walking to their daily activities -- and everyone had to keep a physical activity diary.
That worked for the people who got placebo pills instead of Xenical. After four years, those who stayed with the program lost more than 6.5 pounds.
But those who took Xenical three times a day -- and stayed with the program -- lost nearly 13 pounds.
Staying with any diet program is tough. About two-thirds of those assigned to placebo dropped out of the study, mostly because they weren't happy with how much weight they were losing. In contrast, more than half of those getting Xenical stayed in the study.
Nearly every patient taking Xenical did experience at least one gastrointestinal side effect, mostly in the first year of treatment. Diarrhea is a common side effect of Xenical. Because it blocks the body's ability to digest fats, people taking the drug have to be very careful to eat a low-fat diet. However, most of the Xenical side effects seen in the current study were mild to moderate in intensity.
"The study demonstrated that [Xenical] plus lifestyle changes significantly reduced the incidence of type 2 diabetes over four years and improved weight loss when compared with placebo plus lifestyle changes," Sjöström and colleagues conclude.