[ Back to EurekAlert! ] Public release date: 18-Jun-2002
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Contact: Liz Gofton
liz.gofton@shirehealthinternational.com
44-207-471-1518
Shire Health International

New data shows weight loss with Xenical® provides benefits for type 2 diabetes patients

SAN FRANCISCO, June 17, 2002 – The prescription weight-loss medication Xenical® (orlistat) is effective in helping to control blood glucose and reducing insulin resistance in patients with type 2 diabetes, according to three studies being presented today at the American Diabetes Association (ADA) meeting in San Francisco1,2,3. The studies examined the efficacy of Xenical in overweight or obese patients with type 2 diabetes, looking at its impact on body weight, insulin resistance, glycaemic control, fasting plasma glucose and waist circumference – all important outcome measures in this patient population.

Three separate studies presented by Jaime A Davidson, Ralph De Fronzo, and Aila Rissanen, respectively, assessed pooled data from seven double-blind, placebo-controlled trials of Xenical in overweight or obese patients with type 2 diabetes. Study participants were placed on a mildly reduced calorie diet and were on a variety of anti-diabetic medications (metformin, sulfonylureas and/or insulin). All subjects were randomised to receive Xenical 120 mg or placebo three times per day.

"This collection of data provides strong support for the use of Xenical plus diet in conjunction with diabetes treatments in overweight or obese patients with type 2 diabetes," said Dr Davidson, endocrinologist at Medical City Dallas Hospital and clinical associate professor of medicine at the University of Texas Southwestern Medical School, who presented one of the studies. "Xenical, when combined with a moderate diet, appears to be a valuable tool with benefits in glycaemic control, body weight and waist circumference – all endpoints that matter in this patient population."

Achieving sufficient weight loss is a vital, but notoriously difficult to achieve first step in the treatment of people with type 2 diabetes. Any medication, therefore, which helps people to lose weight and improves blood glucose control is of real value for people who need to control their weight and their type 2 diabetes.

Study Outcomes
Study one - Xenical improves glycaemic control in patients with HbA1c levels ³8% The first study, presented by Associate Professor Davidson, evaluated the efficacy of Xenical in patients who had baseline HbA1c levels of 8%. Mean baseline HbA1c levels were 9.3%. Study results showed that there was a significantly greater reduction in HbA1c in the Xenical group compared to the placebo group (-0.99% vs. -0.52%)1.

When assessing fasting plasma glucose levels, researchers saw a 1.83 mmol/L decrease in the Xenical group compared to a decrease of 0.75 mmol/L in the placebo group. Waist circumference decreased nearly twice as much in patients treated with Xenical compared to placebo (4.00 cm vs. 2.02 cm).

Study two – Xenical improves glycaemic control in patients with varying HbA1c levels
Professor Ralph De Fronzo, chief of the diabetes division at the University of Texas Health Science Center in San Antonio, presented an analysis that examined the effects of Xenical in patients at five different baseline HbA1c levels (on a continuum from ³7% to ³11%)2. Patients receiving Xenical had significantly greater decreases in HbA1c than patients on placebo. Patients with the poorest glycaemic control (HbA1c level ³11%) experienced the greatest reduction in HbA1c levels (-2.2% Xenical vs -1.5% placebo) – a relative improvement of 46% for the Xenical group. For patients with the lowest baseline HbA1c levels (³7% or ³8%) the mean reduction in HbA1c was twice as great in the Xenical group compared to placebo. Mean weight loss was also significantly greater in the Xenical treatment group.

Study three – Xenical significantly reduces insulin resistance
In a third study, presented by Professor Aila Rissanen, from Helsinki University Hospital, Finland, researchers looked specifically at the effect of Xenical on insulin resistance in type 2 diabetes patients with HbA1c levels ³8%. Data demonstrated that Xenical significantly reduced insulin resistance, as measured by the homeostatic model assessment (HOMA) method3. Overall, patients receiving Xenical in addition to their background anti-diabetic medication (either metformin, sulfonylureas and/or insulin) saw a 1.61-point reduction on the HOMA insulin resistance index.

Patients in the placebo and diet group achieved, on average, a 0.41-point reduction on the HOMA index. The benefits of Xenical treatment were consistent regardless of which anti-diabetic medication patients were receiving. Patients receiving Xenical and metformin saw a 1.58-point decrease on the HOMA index, on average, and patients receiving Xenical and a sulfonylureas saw an average 1.68-point decrease on the HOMA index.

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References
1. Davidson J et al. "Efficacy of orlistat in patients with type 2 diabetes with baseline HbA1c levels ³8%". Poster presented at American Diabetes Association (ADA) Meeting San Francisco, 14-18 June 2002
2. De Fronzo R et al. "Effect of orlistat in patients with type 2 diabetes at differing baseline HbA1c levels". Poster Presentation at American Diabetes Association (ADA) Meeting, San Francisco, 14-18 June 2002
3. Rissanen A et al. "Effect of orlistat on insulin resistance in patients with type 2 diabetes with baseline HbA1c levels ³8%". Poster Presentation at American Diabetes Association (ADA) Meeting, San Francisco, 14-18 June 2002

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 13.2 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.

Roche International Award for Obesity Journalism
The Roche International Award for Obesity Journalism is a new initiative to recognise excellence in overweight and obesity reporting. The awards are open to medical and consumer journalists from print, broadcast and electronic media. A prize of US$7,500 will be awarded for each winner in the medical and consumer journalism categories. For more information and submission details, please visit www.managingyourweight.com/formedia/formedia_ja.cfm or contact obesityjournalism@shirehealthinternational.com.

For further information please contact:
Antonia Betts
Shire Health International
Phone: +44 207 471 1525
E-mail:Antonia.Betts@shirehealthinternational.com

Liz Gofton
Shire Health International
Phone: +44 207 471 1518
E-mail:Liz.Gofton@shirehealthinternational.com


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