|January 19, 1999 |
BIRMINGHAM, Ala., -- The experimental anti-obesity drug Xenical (known by the trade name Orlistat) used in conjunction with diet,
promotes slightly greater weight loss and improves obesity-related co-morbid conditions when compared with dietary management
alone, according to a new study in the Journal of the American Medical Association (JAMA). The multi-center study, which
included researchers at UAB (University of Alabama at Birmingham), is the largest and longest of any double-blind
placebo-controlled trial designed to test the efficacy of any weight-loss medication in obese patients. The study also shows that
treatment with Xenical was associated with lower total cholesterol and LDL levels beyond the effects of weight loss alone.
"The results of this study are encouraging," said Douglas C. Heimburger, M.D., professor of Nutrition Sciences and Medicine, who
directed the UAB component of the study. "Weight loss is an important goal in obesity treatment, but equally important are
improvements in obesity-related risk factors. This study shows that Xenical has a beneficial effect on both of these endpoints,
thereby improving patient’s overall health."
However, as with other medications developed for treating obesity, Xenical will not prevent the need for permanent lifestyle
change, according to Heimburger. He also says the drug’s effects disappear within several months to a year after it is
The study was conducted at 18 research centers nationwide and was designed to evaluate whether Xenical combined with a moderate
calorie diet is more effective than placebo plus diet for weight loss and maintenance of weight loss over a 2-year period. The
first year of the study focused on weight loss, while the second year focused on maintenance of weight loss.
A total of 892 adult patients were randomized; 668 subjects received Xenical 120 mg and 224 received placebo. During the first
year of the study, subjects receiving Xenical plus a low-calorie diet lost 8.8% of body weight compared to the 5.8% of body weight
lost by the placebo group on a low-calorie diet alone. At the end of the first year, 65.7% of the Xenical-treated group lost
more than 5% of their initial body weight, compared with 43.6% of the placebo group. Furthermore, 38.9% of the Xenical-treated
group lost more than 10% of initial body weight, compared with 24.8% of the placebo-treated group.
During the second year, patients treated with Xenical 120 mg regained significantly less weight (32% regain) than patients who
received Xenical 60 mg (51.3% regain) or placebo (63.4% regain). Patients who were treated with Xenical 120 mg throughout the
two-years experienced a 7.6% reduction of initial body weight at the end of the study, while those on placebo throughout the
two years showed a 4.2% loss.
In addition to weight loss, Xenical caused significant reduction in total cholesterol, LDL cholesterol, LDL/HDL ratio, glucose,
insulin and blood pressure levels. In addition, treatment with Xenical contributed to lowering total cholesterol and LDL levels
beyond the effects expected with weight loss alone.
Xenical was reasonably well-tolerated. The most common adverse events caused by Xenical were gastrointestinal such as flatus
with discharge and oily spotting. Among the Xenical treated patients, these events occurred early in treatment, were mild to
moderate in intensity and generally resolved spontaneously. Because Xenical partially blocks absorption of dietary fat, it may
affect levels of fat-soluble vitamins such as vitamins D and E. Although vitamin D and E levels did decrease more in the Xenical
group, the changes were small and average vitamin values stayed within normal range.
The United States Food and Drug Administration has not yet approved Xenical for unrestricted use.
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