DATA DEMONSTRATE IMPACT OF WEIGHT LOSS WITH SIBUTRAMINE ON CARDIOVASCULAR RISK FACTORS FOR OBESE PATIENTS

Bangkok--Jun 4--Weber Shandwick (Thailand) Data Address Positive Impact of Weight Loss with Sibutramine On Cardiovascular Risk Factors of Metabolic Syndrome, Left Ventricular Mass, and Predicted Risk of Coronary Heart Disease Data presented on May 26, 2004 at the 13th European Congress on Obesity explored the reduction of cardiovascular risk factors associated with being obese among patients who lost weight with sibutramine treatment. The data presented at the congress demonstrated the relationship of weight loss with sibutramine to improvements in obesity-associated cardiovascular risk factors including metabolic syndrome, reduced left ventricular mass, and lowered predicted risk of coronary heart disease (CHD). "Cardiovascular-related conditions including hypertension, dyslipidaemia and type 2 diabetes are all serious risks for obese patients," stated Professor Arya M. Sharma M.D., Ph.D., Professor of Medicine, Cardiovascular Obesity Research and Management, at McMaster University in Hamilton, Ontario, Canada. "These data are significant because they provide insight into the reduction of cardiovascular risk factors for these obese patients with sibutramine-induced weight loss." Beneficial Effects in Obese Patients with Metabolic Syndrome The majority of obese patients have metabolic syndrome, a condition defined by the presence of three or more cardiovascular risk factors, which include increased abdominal fat (measured by waist circumference), dyslipidaemia (elevated triglyceride levels and reduced HDL cholesterol, typically known as the 'good' cholesterol), hypertension and impaired fasting glucose. Analyses of data from obese patients with metabolic syndrome who participated in five clinical trials with sibutramine and a reduced-calorie diet showed that after 12 months of therapy, 58 percent no longer met the criteria for a metabolic syndrome diagnosis (compared to 40 percent of placebo patients p<0.001). Waist circumference showed a reduction of 10.5 cm in sibutramine-treated patients compared to 5.6 cm in placebo patients (p<0.001). Triglyceride levels showed a reduction in sibutramine patients of 16.6 percent compared to an increase of 2.6 percent on placebo (p<0.001). HDL cholesterol levels showed an increase of 21.7 percent on sibutramine compared to 11.3 percent on placebo (p<0.001). In addition, the STORM (Sibutramine Trial of Obesity Reduction and Treatment) Study Group led by Professor Phillip James, M.D. has previously demonstrated that sibutramine-induced weight loss affected dyslipidemia by lowering triglyceride levels by 19 percent and increasing HDL-cholesterol levels by 21 percent (The Lancet, 2000). These findings, especially the increase in HDL-cholesterol, are beyond what has been seen in clinical trials with weight loss alone. Reduction in Left Ventricular Mass Two thirds of patients with obesity and hypertension have left ventricular hypertrophy, a condition that is associated with serious cardiovascular risk. New data showed that weight loss with sibutramine treatment and a lower-calorie diet reduced left ventricular mass three times more than weight loss from a lower-calorie diet alone (mean 10.9 g compared to mean 3.6 g for placebo, p<0.05). This decrease in left ventricular mass in the sibutramine group is similar to decreases observed in other studies with antihypertensive medication. Cardiovascular Risk in Obese Patients Using risk equations based on the Framingham Heart Study, a meta-analysis presented May 26, 2004 from sibutramine trials including more than 3,000 obese and overweight patients predicts that sibutramine therapy results in a 10 percent relative risk reduction in CHD over a 10-year period. While the Framingham equations used in this analysis do not take into account all known risk factors associated with CHD, their general use within the scientific community to predict outcomes of this sort is widely accepted and validated. These potential treatment benefits of sibutramine are currently being assessed in the landmark Sibutramine Cardiovascular OUTcomes study (SCOUT). This is the first prospective study to examine the role of obesity management in relation to the most common cause of death and disability in the world, cardiovascular disease. "While the connection between obesity and cardiovascular disease is well documented, no study to date has evaluated the impact of long-term weight management as it relates to cardiovascular disease," said the Chairman of the Executive Steering Committee for SCOUT, Professor Philip James, M.D., Chairman of the International Obesity TaskForce. "The SCOUT trial will provide critical long-term data about how physicians can best manage obese patients with cardiovascular disease." More than 5,000 obese and overweight patients at risk for cardiovascular disease have been enrolled in SCOUT since enrollment began in February 2003. This double-blind, randomized, placebo-controlled, multi-center study compares the weight loss effect of sibutramine to placebo on the incidence of heart attacks, stroke and cardiovascular mortality in obese patients at risk for cardiovascular events. Each arm of the trial includes a weight management program. The SCOUT trial will randomize 9,000 patients over approximately five years and will involve more than 300 study sites in 17 countries around the world. "The data presented focuses on the benefits of weight loss with sibutramine that may impact debilitating cardiovascular-related risk factors in obese patients. It is our hope that the ongoing SCOUT trial will yield substantial long-term data on the cardiovascular benefits of weight management in obese and overweight patients," said Professor Sharma. Patients cannot take sibutramine if they are taking prescription medicines called monoamine oxidase inhibitors (MAOI's), which are sometimes used to treat depression or Parkinson's disease. Sibutramine also cannot be taken if patients have anorexia nervosa, bulimia nervosa, are taking other weight loss medications that act on the brain or are hypersensitive to any of the ingredients of sibutramine. Sibutramine substantially increases the blood pressure in some patients. Regular monitoring of blood pressure is required when taking sibutramine. Sibutramine should be given with caution to those patients with history of hypertension, and should not be given to patients with uncontrolled or poorly controlled hypertension. Sibutramine should not be used in patients with a history of coronary artery disease, arrhythmias, congestive heart failure, stroke, severe liver or kidney disease. As with all medications, sibutramine may not be for everyone. Patients should notify their doctor if they are taking medications that regulate the neurotransmitter serotonin in the brain. It is important that patients discuss with their doctor all current and past medical problems, all current symptoms; all medications (prescription, over-the-counter, such as cough and cold medications and any herbal products) that they are currently taking or have recently taken. The most common side effects include headache, dry mouth, constipation and insomnia. Sibutramine is classified as a schedule IV drug in the United States. Sibutramine, along with a reduced-calorie diet and exercise, is recommended for obese patients with an initial body mass index (BMI) greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 in patients with other known risk factors such as hypertension, diabetes, and/or dyslipidemia. Patients being treated with sibutramine should see their doctor as directed for regular follow-up visits, during which the doctor can carefully monitor their overall health, including regular monitoring of blood pressure and pulse rate. Insert local safety information here About Abbott Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries. Abbott 's news releases and other information are available on the company's Web site at www.abbott.com. Contact: Media Outside the U.S.: Sarah Henderson, (847) 938-1170 U.S. Media: Catherine Bryan, (847) 938-8551 Financial Community: John B. Thomas, (847) 938 2655 End. -NT-

• ข่าวCoronary Heart Disease
• ข่าวcardiovascular risk
• ข่าวWeber Shandwick
• ข่าวo:fin
• ข่าวo:loc