To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: NAASO: Xenical Safe And Effective For Long-Term Weight Loss URL: http://www.pslgroup.com/dg/1481A2.htm Doctor's Guide November 17, 1999
CHARLESTON, SC -- November 17, 1999 -- Data from two new studies were announced at the Annual Congress of the North American Association for the Study of Obesity (NAASO) in Charleston. The results of one study conducted in high-risk obese patients confirm the results of the one and two year clinical trials that found Xenical® to be an effective adjunct to diet in long-term obesity treatment with improvement of some obesity-related risk factors. In another short term study, Xenical was found to block as much as 40 percent of dietary fat in healthy adults. The same short term study found that the homeopathic diet aid, Chitosan, had minimal effect on the absorption of dietary fat. Xenical, which acts non-systemically, is the only prescription lipase inhibitor approved by the US Food and Drug Administration for weight loss, maintenance of lost weight and to reduce the risk of weight regain after prior weight loss when used with a reduced calorie diet. Chitosan is an over-the-counter dietary supplement and is not regulated or approved by FDA, nor has its safety and efficacy been established in long term double-blind, placebo-controlled clinical trials. "A number of major studies have recently highlighted some important facts about obesity: it is more widespread than ever before in this country; it is growing faster than ever before; and it is claiming nearly 300,000 lives each year," according to Dr. Louis J. Aronne, Director of the Comprehensive Weight Control Program at Cornell Medical College. "Given the urgency of this situation, Xenical's proven effectiveness with diet for medically significant weight loss and weight management means that it is one of our most valuable treatment tools. Physicians and patients alike should be very encouraged by the continued good news about Xenical," continued Dr. Aronne. Principal Investigator, Dr. Hans Lengsfeld, presented data suggesting that Xenical inhibits fat absorption from a normal standard meal by approximately 40 percent, while Chitosan, a partially decalcetylated dietary fibre extracted from the building block of crustacean shells, long rumored to reduce fat absorption, has minimal effect. The study measured the amount of dietary fat in the fecal excretions of 23 healthy volunteers who received 120mg of Xenical or 750mg of Chitosan during a standardized test meal containing 30-35g of fat. Fecal samples from each treatment group were collected 36 hours prior to and 100 hours after the test meal. Dr. Jon Hauptman, presented a new analysis of data from the 24-month, randomized, placebo-controlled study that evaluated the efficacy of long term obesity management with diet and treatment with Xenical. Results showed 66.7 percent and 37.9 percent of subjects treated with Xenical sustained 5 percent and 10 percent loss of their initial weight, compared to 54.8 percent and 26.7 percent of placebo patients. Experts agree that a 5-10 percent drop in body weight is sufficient to improve risk factors for weight-related conditions like coronary heart disease and diabetes. Additionally, patients who lost weight with Xenical showed a greater decrease in cholesterol, fasting blood glucose and diastolic blood pressure compared to placebo. The Xenical clinical trial program is the longest and largest of any anti-obesity medication. In seven one- and two-year double-blind, placebo-controlled and randomized clinical trials involving more than 7,000 patients worldwide, those who took Xenical with reduced calorie meals containing up to 30 percent fat achieved significant weight loss with improvements in many obesity-related risks for coronary heart disease such as high cholesterol, high blood pressure and diabetes. Specifically, results of the pooled data show: -- Almost three times as many patients taking Xenical in addition to a reduced calorie diet vs. reduced calorie diet alone achieved weight loss of more than 10 percent body weight. -- Approximately twice as many lost at least 5 percent body weight. -- Patients taking Xenical lost on average twice as much weight as those on a reduced calorie diet alone (13.4 lbs. vs. 5.8 lbs.) -- Patients losing weight with Xenical had statistically significant reductions in total and low-density lipoproteins (LDL) cholesterol and systolic and diastolic blood pressure, as well as improved concentrations of fasting glucose and insulin. -- Leading medical experts agree that a weight loss of 5-10 percent of initial body weight results in meaningful improvements in health. Xenical, the only prescription lipase inhibitor approved by the FDA, acts by blocking the absorption of dietary fat by approximately 1/3. The drug is prescribed for obesity management including weight loss, weight maintenance, and to reduce the risk for weight regain after prior weight loss when used in conjunction with a reduced-calorie diet. When compared to diet alone, weight loss with Xenical also results in measurable improvements in certain obesity-related conditions, such as high blood pressure, high cholesterol and diabetes. Unlike other anti-obesity agents that work in the brain to suppress appetite, Xenical, through its fat-blocking mode of action, works non-systemically in the gastrointestinal tract, not requiring entry into the bloodstream or brain. Blocking 1/3 of fat from digestion means that a patient who ingests 60 grams of fat a day may absorb only 40 grams of fat. The other 20 grams will be excreted through the digestive tract. The drug is recommended for use three times daily with meals that contain up to 30 percent of calories from fat, consistent with current U.S. dietary guidelines. Xenical is indicated for obese patients with an initial body mass index (BMI) of greater than or equal to 30 or greater than or equal to 27 in the presence of other risk factors, such as high blood pressure, high cholesterol, and diabetes. Xenical is contraindicated in patients with chronic malabsorption syndrome or cholestasis (reduced bile flow) and should not be taken simultaneously with cyclosporine. Organic causes of obesity, such as hypothyroidism, should be excluded before prescribing Xenical. Gastrointestinal symptoms are the most commonly observed side effects associated with the use of Xenical and are primarily a manifestation of its mechanism of action. These effects are generally mild and transient and may include oily spotting, flatulence with discharge, fecal urgency, fatty or oily stool, oily evacuation, increased defecation and fecal incontinence, particularly after meals containing more fat than recommended. Patients should try to follow a healthy eating plan such as the one developed by the American Heart Association. Following this eating plan will help patients lose weight while decreasing some of the possible gastrointestinal effects one may experience while taking Xenical. Because Xenical partially blocks fat absorption, it has been shown to reduce the absorption of some fat-soluble vitamins. Therefore patients are advised to take a daily multi-vitamin supplement that contains vitamins D, E, K and beta-carotene. Related Link: Xenical. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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