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Title: New Data Confirm Rapid And Sustained Weight Loss With Xenical (Orlistat) 4kg Loss In First Month Rising To 11.6kg After One Year

"New Data Confirm Rapid And Sustained Weight Loss With Xenical (Orlistat) 4kg Loss In First Month Rising To 11.6kg After One Year"

BASEL, SWITZERLAND -- May 28, 2002 -- The weight loss medication Xenical (orlistat) helps patients achieve rapid and sustained weight loss according to the results of a new study designed to reflect usage in a clinical practice setting.1 The 12 month study of 430 overweight men and women (BMI of 30-43 kg/m˛), was designed to assess the efficacy of Xenical in patients who are responsive to treatment. Patients who achieved 5 per cent (approximately 5kg) weight loss after 3 months and maintained this after a further 3 months of Xenical treatment, were followed for a total of 12 months. During this time weight loss and other health improvements, such as blood pressure reductions, were assessed. The results suggest that the efficacy of Xenical in a clinical practice setting is even greater than that demonstrated previously in placebo-controlled studies: ˇ The greatest weight loss was seen in the first four weeks of treatment, with patients losing 4.1 kg ˇ 75 per cent of patients (n= 322) achieved ł 5 per cent weight loss by month three, losing an average of 8kg ˇ 92 per cent of these patients (n= 295) maintained ł 5 per cent weight loss by month six, with a mean weight loss of 10.9kg. This was maintained for the remainder of the study with patients losing 11.6kg after one year ˇ At the end of the study over half of the patients (51.5 per cent) lost ł10 per cent of their baseline bodyweight and 84.4 per cent were able to lose ł 5 per cent - an amount of weight loss shown to clinically improve the health and well-being of overweight people2 Commenting on the results, lead study investigator Professor Hermann Toplak from the Karl-Franzens-Universität, Graz, Austria said: "This study demonstrates the significant benefits of rapid and continuous weight loss with Xenical in a clinical practice setting. Patients who respond rapidly to treatment remain compliant and achieve long-term success." Results also demonstrated significant health gains associated with weight loss with Xenical. Specifically, patients treated with Xenical achieved improvements in: ˇ Blood pressure (bp): In patients with hypertension, mean systolic and diastolic blood pressure were reduced by 18.1mmHg and 9.9mmHg respectively ˇ Cholesterol: The lipid profile of patients was markedly improved: mean LDL-cholesterol levels were reduced by 10.7 per cent and mean total cholesterol levels by 6.8 per cent ˇ Waist circumference: A mean reduction of 10.8 cm was achieved after one year. Excess fat around the waist is associated with insulin resistance, high blood sugar, high cholesterol levels and high blood pressure. The reductions in blood pressure are a key finding as the number of overweight people with hypertension is almost three times higher than the number of adults with a healthy weight.3 Xenical is the only prescription weight-loss medication which can be used in patients with hypertension or uncontrolled hypertension.4 Xenical's mode of action is unique. Unlike appetite suppressants, which have a history of withdrawals because of safety concerns, Xenical does not act on the central nervous system. As a result of Xenical's non-systemic mode of action, it has a safety and tolerability profile, which makes it appropriate for use in a wide range of patients. This is particularly important within the area of overweight / obesity, where a significant number of patients suffer from, or are at risk of cardiovascular disease. References: 1. Toplak H. Oral Presentation at Seville, Roche Event, 31 May - 1 June 2002 2. Goldstein DJ. International Journal of Obesity (1992). 16:397-415 3. Pi-Sunyer FX. "Medical Hazards of Obesity." Ann Intern Med (1993). 119: 655-660. 4. Yanovski S et al. Obesity. NEJM 2002; 346 (8): 591-602 Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30 per cent and effectively promotes weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike appetite suppressants, it does not act on the brain. In clinical trials people taking Xenical in conjunction with a mildly reduced calorie diet have shown twice as much weight loss as diet alone. Since it was first marketed in 1998, there have been more than 11.5 million patient treatments with Xenical world-wide. Xenical is licensed for weight management in 149 countries around the world. For further information please go to: www.managingyourweight.com About Xenical Weight Management Programmes Roche has developed Xenical weight management programmes (WMPs) for healthcare professionals to use with their patients. The programme aims to help patients set and reach realistic weight goals while modifying their dietary intake and behaviour in the long-term. The programmes are individually tailored to help people achieve their weight loss goals, and maintain weight loss, through healthy eating, physical activity, behaviour modification and pharmacotherapy. Roche provides free patient support programmes in around 50 countries worldwide to help support people taking Xenical. Recent data demonstrated that patients enrolled in Xenical WMPs can significantly improve the levels of weight loss achieved and can increase their overall satisfaction and compliance with treatment. About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading research-orientated healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well-being and quality of life. SOURCE: Shire Health

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