Roche announced today that the European Union's Committee for Proprietary Medicinal Products (CPMP) has given a positive recommendation to extend the European label for its weight loss medication Xenical® to include:
four year data on weight loss;
long-term safety and tolerability profile; and
reduced risk for developing type 2 diabetes.
The decision is based on the results of the landmark XENDOS (XENical in the prevention of Diabetes in Obese Subjects) study, which showed for the first time that a weight loss medication could significantly reduce the risk of developing type 2 diabetes.
XENDOS is the largest and longest study of a weight loss medication, treating 3304 patients for four years with Xenical plus lifestyle changes, or lifestyle changes alone. It is also the first study to assess whether treatment with a weight loss medication, Xenical, can reduce the risk of developing type 2 diabetes. The study showed that losing weight with Xenical reduced the risk of developing diabetes by 37% compared with lifestyle changes alone and by 52% in patients with impaired glucose tolerance (IGT or pre-diabetes). Compared to lifestyle changes alone, Xenical treatment produced significantly greater long-term weight loss and improvements in cardiovascular risk factors (including blood pressure and lipids). The study also confirmed that Xenical has a long-term safety profile that is unmatched in the field of weight loss.
"The CPMP's decision is an important step towards expanding the European label for Xenical, which we believe will provide physicians with an effective strategy for helping patients lose weight and thereby delaying or preventing type 2 diabetes," commented Dr. Paul Brown, Life Cycle Leader for Xenical.
The CPMP's positive opinion will now be proposed for approval by the European Commission.
Type 2 diabetes
Health experts have warned of a global epidemic of diabetes caused by a rise in overweight and obesity. There are currently 120-140 million people worldwide with type 2 diabetes, and if trends continue, this number is predicted to double in the next 25 years.2 More than 90% of all people with type 2 diabetes are overweight or obese.3 Because of the severe health and cost implications of type 2 diabetes, organisations such as the International Diabetes Federation (IDF) have called for increased efforts to prevent the development of type 2 diabetes. The IDF estimates that 314 million people worldwide, or 8.2% of the global population, have impaired glucose tolerance, a state that often precedes type 2 diabetes.
Excess weight is well recognised as the most important modifiable risk factor for the development of type 2 diabetes. A number of recent studies have shown that lifestyle changes (diet and exercise) have a dramatic effect on delaying or preventing the development of type 2 diabetes.5, 6 The XENDOS study represents an important step forward in the evolution of diabetes prevention studies through the study design and the outcomes that were measured.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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They called me mad, and I called them mad,
and damn them, they outvoted me.