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| |  Xenical Promotes Weight Loss, Helps Keep It Off For Two Years, Study Shows CHICAGO, IL -- Jan. 19, 1999 -- Taking Hoffman-LaRoche’s drug Xenical (orlistat) helps promote weight loss, lessens weight regain and improves some obesity-related disease risk factors, according to an article in tomorrow’s issue of The Journal of the American Medical Association. Steven Heymsfield, M.D., of the Obesity Research Center at St. Luke’s-Roosevelt Hospital in New York, Michael Davidson, M.D., of the Chicago Center for Clinical Research, and colleagues evaluated 880 obese adults to test whether orlistat combined with dietary intervention is more effective than placebo plus diet for losing weight and keeping the weight off for two years. The participants, who met the definition of obese with ratings of 30 to 43 on the body mass index, a measurement to determine body fat (for example, a five-food-six woman weighing more than 186 pounds), were randomised to receive placebo or 120 mg of orlistat three times a day for the first year. In the second year, the participants were placed on a weight maintenance diet and the orlistat group was randomised again to received either placebo or 60 mg or 120 mg of Orlistat, while the placebo group remained the same. This is the largest placebo-controlled, double-blind study to test the effectiveness of a drug for weight loss and prevention of weight regain over a two-year period. The researchers found that patients taking orlistat in the first year lost more weight (19.31 pounds) than those taking placebo (12.8 pounds). Patients treated with 120 mg of orlistat in the first and second year also regained less weight during the second year (7.05 pounds) than those who received 60 mg of orlistat (9.39 pounds) or placebo (12.41 pounds) during the second year. Treatment with 120 mg of orlistat three times a day was associated with improved low-density lipoprotein cholesterol (LDL-C, the bad cholesterol) and insulin levels. Additionally, the researchers report that 34.1 percent of patients who completed two full years of 120 mg of orlistat three times a day maintained a weight loss of more than 10 percent of their initial body weight, compared with only 17.5 percent of patients who received placebo for two years. According to information cited in the study, obesity affects an increasing number of Americans and poses a therapeutic challenge to physicians. Conventional non-drug interventions based on diet and exercise have had limited long-term success in producing sustained weight loss. Obesity is believed to contribute to the development of a number of serious health conditions, including diabetes, cardiovascular disease and an increased risk of death and disability. Orlistat, one of the drugs available to aid weight loss, is a minimally-absorbable agent that prevents the body from absorbing approximately 30 percent of ingested fat. "This study demonstrates that partial inhibition of fat absorption in obese subjects can produce sustained weight loss," the authors write. "Subjects treated with orlistat plus a mildly controlled-energy diet lost significantly more weight than those treated with placebo plus diet even though all subjects received a high standard of care and similar dietary counselling. "These observations collectively suggest that orlistat may be a useful adjunct to dietary intervention in producing and maintaining weight loss over two years." Related Links: Xenical, Hoffman, The Journal of the American Medical Association,
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