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New study: Xenical significantly improves 5 out of 5 Metabolic Syndrome abnormalities

New study: Xenical significantly improves 5 out of 5 Metabolic Syndrome abnormalities

HELSINKI, FINLAND, May 30, 2003 -- Xenical is significantly more effective than diet alone in reducing weight and simultaneously improving cardiovascular risk factors in patients with Metabolic Syndrome, according to new outcomes from the landmark XENDOS study, presented at the 12th European Congress on Obesity (ECO), Helsinki, Finland.[1]

Metabolic Syndrome, otherwise known as Syndrome X or insulin resistance syndrome, describes a 'cluster' of 3 or more risk factors, such as high waist measurement, increased fasting glucose levels, abnormal blood lipid levels and high blood pressure in a single patient, leading to an increased risk of cardiovascular disease. Up to one in five people in Western countries is considered a 'cardiovascular time-bomb' because they have Metabolic Syndrome.[2] Weight loss is the only intervention that has been shown to improve all of the cardiovascular risk factors seen in patients with Metabolic Syndrome.[3]

This new analysis from XENDOS examined the effects of treatment with Xenical in patients with Metabolic Syndrome, based on criteria from the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP III)*. Forty per cent of XENDOS study participants had Metabolic Syndrome.

In Xenical-treated patients results showed:

  • More than twice as much weight loss as those on diet alone (-6.4kg vs -2.9kg)
  • A significantly greater reduction in waist measurement compared to those on diet alone (-6.1cm vs -3.8cm)
  • A significantly greater reduction in systolic and diastolic blood pressure compared to those on diet alone (-5.4mmHg vs -3.5mmHg and -3.1mmHg vs -2.0mmHg respectively)
  • A significantly greater reduction in triglyceride levels compared to those on diet alone (-6.3% vs -5.5% decrease from baseline)
  • Significantly lower fasting plasma glucose levels compared to those on diet alone (0.08mmol/L vs 0.22mmol/L)
  • An increase in HDL (good) cholesterol (+9.0% from baseline)

In addition, significantly fewer Xenical-treated patients progressed to type 2 diabetes compared to those on diet alone (9.8% vs 13.7%), a relative risk reduction of 36%.

Commenting on the results of the study, XENDOS co-principal study investigator Dr Jarl Torgerson said "Metabolic Syndrome is fast becoming the epidemic of the 21st century, with serious implications for cardiovascular disease in the future. These study results show that Xenical boosts the beneficial effects of weight loss in people with Metabolic Syndrome. Xenical, together with lifestyle changes, is a powerful approach to the effective management of this condition."

XENDOS was the first large-scale and longest clinical trial to assess the efficacy and safety of a weight loss medication (3304 patients over 4 years). It was also the first study of a weight loss medication to show a reduction in the risk of developing type 2 diabetes. These results are a significant step forward in showing that treatment with Xenical in combination with lifestyle modification is more effective than lifestyle intervention alone both in diabetes prevention and weight loss.

*ATP III Criteria[4]

Describes patients with 3 of the following criteria: high fasting glucose levels (>6.1 mmol/L), high waist measurement (>102 cm in men or >88 cm in women), low high density lipoprotein cholesterol (HDL, <1 mmol/L men or <1.3 mmol/L women), high triglyceride levels (>1.7 mmol/L) and high blood pressure (>130/85 mm Hg).

References:

1. Torgerson J. XENDOS - A Unique Advantage. Presented at the satellite symposium "Making the right moves for success" at the European Congress on Obesity; May 2003, Helsinki, Finland.

2. Ford, E.S., Giles, W.H., Dietz, W.H. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA 2002; 287: 356-9.

3. Scottish Intercollegiate Guidelines Network: Clinical guidelines. Obesity in Scotland. Integrating prevention with weight management. November 1996.

4. Adult Treatment Panel III (ATP III) Criteria. National Cholesterol Education Programme - 3rd Report of the National Cholesterol Education Programme (NCEP). www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf

Source: Roche www.roche.com

Posted: May 2003


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