Based on pooled analysis in a subpopulation of elderly obese patients, the data suggest that Xenical is effective for weight loss in this population. The weight loss in obese elderly also resulted in improvements in many of the serious health risks associated with obesity. These data, presented today at the annual meeting of the North American Association for the Study of Obesity (NAASO), are promising for the elderly obese - a patient population for which advanced age and fragile health have traditionally combined to limit obesity treatment options.

"Clinically meaningful weight loss is difficult to achieve in this patient age group," said Dr. Charles Lucas, Medical Director, Roche Laboratories. "These data suggest that Xenical can play a critical role as a treatment for obesity with its related risk factors in older patients."

The patients, 65 years of age and older, in this analysis had a body mass index (BMI) of 30 or more. Patients were treated with a reduced calorie diet plus 120 mg of Xenical (tid) or placebo in these one and two year double-blind, placebo-controlled trials. The results of this analysis suggest patients treated with Xenical experienced significantly greater weight loss than patients receiving placebo.

Cardiovascular disease risk factors (including total cholesterol, low-density lipoprotein and systolic blood pressure) also improved more significantly among patients treated with Xenical. The medication was well tolerated among elderly patients and had a similar side-effect profile to that reported for the population as a whole.

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 7000 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 five percent body weight.
• Patients taking Xenical lost on average twice as much weight as those on a reduced calorie diet alone (13.4 lb 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. 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 and does not require 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 reduced-calorie 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. The drug 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. Patients are therefore advised to take a daily multi-vitamin supplement that contain vitamins D, E, K, and beta-carotene.

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