News Release

New data shows rapid and sustained weight loss with Xenical

Peer-Reviewed Publication

Shire Hall Communications

4kg loss seen in first 4 weeks

The weight loss medication Xenical helps overweight and obese people lose weight rapidly and is associated with rapid improvements in cardiovascular risk factors according to preliminary results of new research being presented at the North American Association for the Study of Obesity (NAASO) meeting in Québec City, Canada1. A second presentation showed Xenical helps maintain weight loss for up to two years2.

In an ongoing study, conducted by Professor Hermann Toplak from the Karl-Franzens-Universität, Graz, Austria, men and women with a BMI of 30-43 kg/m2 were randomised to treatment with Xenical plus diet (either 500kcal or 1000kcal/day deficit). Of the 430 people who have participated in the study, 83 per cent achieved clinically meaningful weight loss of ≥5 per cent of their body weight in the first 12 weeks of treatment – an amount of weight loss shown to clinically improve the health and well-being of overweight people1,3. The average weight loss achieved by these patients after 12 weeks was 8 kg (or 7% of their body weight).

This weight loss was also associated with rapid improvements in cardiovascular risk factors in the first month of treatment. Reductions were seen in mean diastolic and systolic blood pressure (by 1.3 and 2.6 mmHg, respectively) after the first four weeks of treatment, with further improvements after 12 weeks (to a reduction of 3.0 and 4.3 mmHg respectively).

Further results from the first 12 weeks of the study showed:
· The greatest weight loss was seen in the first four weeks of treatment (4.1kg lost) followed by patients losing a further 2 kg every 4 weeks to week 12.
· BMI was reduced by 2.9kg/m2 on average
· Waist circumference was reduced by 6.3cm on average. Excess fat around the waist is associated with insulin resistance, high blood sugar, high cholesterol levels and high blood pressure.

"This study shows the significant benefits of rapid and continuous weight loss in the first 12 weeks of treatment with Xenical. Not only are there associated health advantages, but patients may also improve their motivation to lose weight and experience greater satisfaction with treatment," Professor Toplak said.

"One of the biggest problems with weight loss programmes is that patients drop out because they do not experience early improvements in body shape or well-being. Rapid weight loss with Xenical means patients are more likely to experience these changes and consequently comply with treatment and succeed long-term on a weight management programme."

A second presentation at NAASO also confirms that Xenical is successful in maintaining weight loss over a 2 year period2. The data presented by Professor Aila Rissanen, Helsinki University Hospital, Finland, demonstrate that in a group of patients who responded to treatment with Xenical:

· Weight loss was 10.4kg after 2 years (10.6%)
· Total cholesterol was reduced by 9% - (LDL decreased by 10%, HDL increased by 9%, Triglycerides decreased by 14%)
· Reductions were seen in mean diastolic and systolic blood pressure (by 4.6 and 9.4 mmHg, respectively)

These studies show that Xenical helps people not only lose weight rapidly, but that it helps maintain weight loss and its associated health benefits for up to two years.

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Notes to Editors:

About Xenical:
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 the most extensively studied pharmacological weight management treatment to date, with over 30,000 overweight or obese patients participating in clinical trials with Xenical. 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 twice as many people taking Xenical in conjunction with a mildly reduced calorie diet have achieved a clinically significant weight loss (>5 -10%) compared to those taking placebo and diet. Since it was first marketed in 1998, there have been more than 10 million patient treatments with Xenical world-wide. Xenical is licensed for weight management in over 100 countries around the world.

Weight management programmes:
Weight Management Programmes are provided in around 45 countries around the world to help support people taking Xenical.

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.

For further information please contact:

Antonia Betts
Shire Hall International
Phone: +44 207 471 1520

OR

Patrick Ward
Shire Hall International
Phone: +44 207 471 1523

References:
1. Toplak H, Sharma AM, Van Gaal L. "Rapid weight loss with orlistat plus diet after 12 weeks of treatment". Poster presented at NAASO, Québec City, 2001.
2. Rissanen A, Rössner S, Chen KW. "Effect of weight loss with orlistat on cardiovascular disease risk prediction in high-risk obese adults". Poster presented at NAASO, Québec City, 2001.
3. Goldstein DJ. International Journal of Obesity (1992). 16:397-415.


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