Xenical May Have Role In Long-Term Management of Obesity

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Clinical data presented today at the North American Association for the Study of Obesity (NAASO) Annual Meeting show that Hoffman-La Roche's Xenical(R) (orlistat) may be effective for the long-term management of obesity. Researchers presented results from several abstracts on Xenical, which is being investigated to promote weight loss, weight maintenance and reduction in the risk of weight regain and to improve obesity-related disease factors when compared to diet alone.

Approximately 58 million, or one-third of American adults are overweight or obese. Among adults, the incidence of obesity has increased from 25 to 32 percent in the last 10 years. Obesity is second only to smoking as a cause of preventable death in the US, and is a major contributing factor to serious medical conditions such as diabetes, hypertension and other cardiovascular diseases. Xenical is the first of a new class of non-systemic anti-obesity drugs called lipase inhibitors which act in the gastrointestinal tract to prevent the absorption of fat by about 30 percent. Drugs in this class do not achieve their effect through brain chemistry. Roche originally submitted a New Drug Application (NDA) for Xenical in 1996. An FDA Advisory Committee unanimously recommended approval of Xenical on May 14, 1997. Roche later withdrew its original NDA to conduct further analyses of data at the request of the FDA. Hoffmann-La Roche expects to resubmit the NDA for Xenical within a few days.

In a poster presentation, John Foreyt, PhD, Baylor College of Medicine reported that after one year, patients taking Xenical 120 mg in conjunction with a mildly hypocaloric diet lost significantly more weight than those taking placebo in conjunction with a similar diet (57 percent of patients treated with Xenical lost more than five percent of their initial weight vs. 34 percent of patients taking placebo).

During the second year, significantly less weight was regained in those patients who continued taking Xenical than in patients who switched to placebo (35 percent vs. 63 percent regain of lost weight). Xenical also reduced total cholesterol and LDL cholesterol levels, as well as mean systolic and diastolic blood pressure, compared to diet alone.

The clinical trial showed that Xenical was well-tolerated. The most common side effects reported were non-systemic and primarily gastrointestinal. These effects generally occurred early in treatment and were self-limited and of short duration in most cases. In a poster presented by James Anderson, MD, chief of the endocrine-metabolic section at the VA Medical Center, Lexington, KY, 729 obese patients who had lost more than eight percent of their initial body weight after 24 weeks on a hypocaloric diet, were randomized to receive Xenical 120 mg tid, 60 mg tid, 30 mg tid or placebo in conjunction with a diet designed to help prevent weight regain rather than promote weight loss.

After one year of treatment the amount of weight regain was significantly less in the Xenical 120 mg group than in the placebo (32 percent regain vs. 56 percent with placebo). Furthermore, patients taking Xenical 120 mg experienced significant reductions in total cholesterol and LDL-cholesterol levels compared to diet alone.

The clinical trial showed that Xenical was well-tolerated. The most common side effects reported were non-systemic and primarily gastrointestinal. These effects generally occurred early in treatment and were self-limited and of short duration in most cases. A one-year study of weight loss and glycemic control in type 2 diabetics following orlistat (xenical) treatment, was presented by David Kelley, MD, associate director of the metabolism and body composition research core at the University of Pittsburgh Obesity and Nutrition Research Center. This study examined the efficacy of Xenical in patients with Type 2 diabetes taking sulfonylureas (medications used to control glucose levels) -- a patient group in which it is typically difficult to achieve sustained weight loss.

Results show that patients taking Xenical lost significantly more weight than in those treated with placebo. After one year of treatment, HbA1c levels decreased in the Xenical group but increased in the placebo group. Sulfonylurea doses were reduced 23 percent in the Xenical group versus nine percent in placebo. In addition, more than twice as many Xenical patients lost greater than five percent of initial body weight (49 percent on Xenical versus 23 percent on placebo).

Patients treated with Xenical also showed a significant decrease in total cholesterol and LDL cholesterol compared to diet alone. The clinical trial showed that Xenical was well-tolerated. The most common side effects reported were non-systemic and primarily gastrointestinal. These effects generally occurred early in treatment and were self-limited and of short duration in most cases. The impact of Xenical treatment on quality of life was examined in research presented by Susan Mathias, MPH, senior analyst at the Technology Assessment Research Group. Results of this study show patients taking Xenical 120mg tid for up to two years reported a greater decline in overweight distress, more satisfaction with treatment and slightly improved depression than patients receiving placebo. Data was obtained through a new health-related quality of life (HRQoL) measure and an obesity-specific health state preference assessment.