EC issues a positive opinion reaffirming the safety and efficacy of Reductil

"As a physician who treats obese patients, the conclusion that sibutramine is safe and effective for the treatment of obesity is consistent with my own experience using sibutramine in treating this disease," said Dr. Stephan Rössner, head of the Obesity Unit, Huddinge University Hospital, Stockholm, Sweden. "Obesity is an international epidemic. It contributes significantly to the onset of other serious medical conditions such as diabetes, cardiovascular diseases, cancer and respiratory conditions. Reductil, when used in combination with diet and exercise, is an important tool in my practice that helps treat obesity."

Dr. Ali Bakir, Head of the Endocrinology Department, Mafraq Hospital and the principal investigator of the Emirates National Diabetes Study (ENDCAD), added, "The results of the investigation confirm my professional experience with Reductil, which is one of the important tools against the disease of obesity, provided its use is combined with diet and exercise."

Ibrahim Aql, General Manager, Gulf region, Abbott Laboratories, said, "The CPMP's conclusion should reassure physicians and patients who depend on sibutramine to treat obesity that the product is safe when used as directed."

The positive opinion of the CPMP was supported by an extensive analysis of data provided by Abbott that included more than 100 clinical studies of sibutramine, dating back to 1989. These studies investigated the use of sibutramine in more than 12,000 obese patients. To date, more than 8.5 million people in more than 70 countries have used sibutramine for the management of obesity. Reductil is the most extensively studied prescription medication currently available for the treatment of obesity.

The CPMP's positive opinion represents the outcome of a rigorous scientific review of data by the 15 European Member States. This positive outcome is binding for all member states. The CPMP's scientific review of sibutramine adds to the world's collective scientific knowledge of Reductil's safety and effectiveness in treating obesity.

The World Health Organization (WHO) recognizes obesity as a global epidemic and serious public health issue. Being overweight or obese substantially increases the risk of hypertension, type 2 diabetes mellitus, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and other respiratory problems, and certain types of cancers (endometrial, breast, prostate, and colon).

Clinical studies show that weight loss of five to 10 percent (which Reductil has been shown to achieve) significantly reduces the incidence of disease and premature death in obese patients - including, for example, a 58 percent reduction in the rate of type 2 diabetes mellitus and a 20 percent reduction in mortality. In studies, Reductil in combination with diet and exercise was effective in producing and maintaining statistically significant weight loss in the majority of obese patients compared to diet and exercise alone.