FIRST LARGE SCALE INTERNATIONAL PRIMARY CARE STUDY CONFIRMS A HIGH WAIST CIRCUMFERENCE IS INDEPENDENTLY ASSOCIATED WITH CARDIOVASCULAR DISEASE

Press Release Issued on behalf of the IDEA steering committee and the investigators. Results from the IDEA Study Highlight the Rising Worldwide Pandemic of Abdominal Obesity Atlanta, GA, USA, March 14, 2006 - Results from the first large scale international study assessing prevalence of abdominal obesity in over 170,000 people confirm that a high waist circumference is associated with cardiovascular disease (CVD) independently of body mass index (BMI) and age.1 The International Day for the Evaluation of Abdominal Obesity (IDEA) study, involving a random sample of more than 6,000 primary care practitioners in 63 countries, shows that abdominal obesity is highly prevalent worldwide among people in a primary care setting.1 The IDEA study results, presented today at the American College of Cardiology’s 55th Annual Scientific Session in Atlanta, show that waist circumference and BMI are both determinants of CVD. However, the relationship of waist circumference measurement with the increased prevalence of CVD was shown to be independent of the relationship of BMI with CVD, regardless of age or geography.1 “The IDEA study confirms to us the importance of measuring waist circumference, alongside current measures such as BMI, blood pressure, blood glucose and lipid levels, in identifying patients in a primary care setting who are at increased cardiometabolic risk,” said Steve Haffner, M.D., Professor of Medicine at the University of Texas Health Science Center in San Antonio, Texas, and member of the IDEA Study Executive Committee. Cardiometabolic risk is the global risk of developing type 2 diabetes and CVD.2 Cardiometabolic risk is determined by the presence of traditional risk factors such as LDL-cholesterol (bad cholesterol), hypertension (elevated blood pressure), type 2 diabetes and smoking as well as by a cluster of emerging markers linked to insulin resistance that are most frequently found in clinical practice among patients with abdominal obesity, especially those with an excess of intraabdominal adiposity (too much “high risk” abdominal fat). Among these clustering emerging markers affecting cardiometabolic risk are increased C-reactive protein (CRP), a marker of inflammation, and reduced adiponectin, an adipose tissue protein that protects against the development of diabetes and CVD. 3,4 These abnormalities are often found clustered together with abdominal obesity, elevated triglycerides (blood fat), low HDL-cholesterol levels (good cholesterol), elevated blood glucose (high blood sugar) and high blood pressure.5 The study not only measured prevalence of abdominal obesity but also determined the relationship between the presence of CVD, waist circumference and BMI. An analysis of the results demonstrated that in both men and women, waist circumference and BMI were both independently associated with the presence of CVD. Furthermore, the IDEA study results provide evidence that waist circumference itself is associated with cardiovascular disease independent of the effect of BMI and increasing age.1 Age and waist circumference are important determining factors for CVD. Every increase in age by 16 years triples the likelihood of an adult having CVD and each increase in waist circumference of 14 cm for men and 14.9 cm for women increases the likelihood of a person having CVD from 21 percent to 40 percent.1 The worldwide prevalence of known CVD in men in the primary care population in the IDEA study was 16 percent and ranged between 10 percent in Latin America to 26 percent in Eastern Europe.1 The worldwide prevalence of known CVD in women was 12.5 percent and ranged between seven percent in North America to 23 percent in Eastern Europe.1 The IDEA study confirms the pandemic nature of abdominal obesity. The results independently confirm and support the findings of the INTERHEART study but add greatly to this knowledge because of the size and geographic spread of the IDEA study population.6 The patient participation rate in the survey was high, with 97 percent of patients agreeing to have their waist circumference measured by their primary care physician, suggesting that waist circumference can be easily measured and included in clinical practice worldwide.1 “This is the first time a study of this magnitude has been conducted worldwide in a primary care population,” said Jean-Pierre Després, Ph.D., Director of Research, Cardiology, Hôpital Laval, Université Laval, Québec City, Québec, Canada and member of the IDEA Study Executive Committee. “These figures show that patients do not feel that having their waist measured is intrusive. The importance and the clinical significance of these results will stimulate initiation of additional studies that will aid us in identifying patients most at risk and help us to evaluate the impact that new treatments will have on the overall cardiometabolic risk of these patients,” said Dr. Després. BMI, an established risk factor for CVD, does not take into account the wide variation in body fat distribution across different individuals and populations.7 Measurements that are more sensitive to individual differences in abdominal obesity might be useful for identifying CVD. Waist circumference is a convenient measure of abdominal obesity that is unrelated to height and correlates closely with BMI and total body fat.7 Abdominal obesity can be simply measured by waist circumference and is an indicator of intra-abdominal adiposity, the hidden fat present deep within the abdomen associated with the development of metabolic disorders.8 Intra-abdominal adiposity has been identified as an underlying cause of cardiometabolic risk factors, such as elevated triglycerides, low HDL-cholesterol and high blood sugar.9 While adipose tissue is useful for storage and release of energy, it produces active substances known as hormones. Too much of this “high risk” fat is responsible for abnormal levels of these substances, interfering with normal metabolic function and leading to high blood sugar and unhealthy cholesterol levels, which can increase the risk for heart disease and diabetes.10 CVD is the leading cause of death and has emerged as a prominent public health issue around the world.11 One in 8 men and one in 17 women die from CVD before the age of 65 in European countries.12 Obesity is typically measured by BMI; however, recent findings have shown that abdominal obesity is a much better determinant of CVD risk than weight or BMI.6 IDEA survey objectives and design The IDEA study was an international non-interventional epidemiological cross-sectional study conducted in 63 countries across five continents. The study aimed to estimate the prevalence of abdominal obesity, as measured by waist circumference, in an unselected population of consecutive patients consulting a randomly selected sample of primary care physicians on two pre-specified half-days. The study also estimated the association between abdominal obesity, CVD and other cardiometabolic risk factors. The study utilised a complex methodology, taking a random sample of primary care physicians; representing all geographic areas within each participating country. This ensured that a good representation of patient data was collected. All patients aged between 18 and 80 years consulting their primary care physician on the two pre-specified half-days were asked for informed consent and invited to participate, irrespective of their reason for consultation. The variables assessed and recorded were waist circumference (measured in centimetres or inches), height (cm/in) and body weight (kg/lbs). In addition, demographic data were collected on gender, age and highest level of education. The presence or absence of classical CVD risk factors such as smoking status, dyslipidaemia, hypertension, diabetes and existing CVD (coronary heart disease, stroke or prior revascularisation) were also recorded. Of 182,970 patients screened, 177,345 patients agreed to participate, a response rate of 97 percent. Data was analysed in 168,159 patients (69,409 men; 98,750 women) meeting the inclusion criteria and for whom full data records were obtained. The IDEA survey is the first part of a large epidemiological programme and will be followed by two other studies: the International Study of Prediction of Intra-Abdominal Adiposity and its Relationship with Cardiometabolic Risk/Intra Abdominal Adiposity (INSPIRE ME) and the INSPIRE ME Intra-Abdominal Adiposity (INSPIRE ME/IAA) study. INSPIRE ME will provide further epidemiological evidence of the relationship between cardiometabolic risk markers and previous CVD events and type 2 diabetes. INSPIRE ME/IAA will have a prospective design with a follow-up of three years; by capturing the new occurrence of cardiovascular events or type 2 diabetes this study will provide further evidence on the link between intra-abdominal adiposity (measured by CT- scan), waist circumference and these cardiovascular and metabolic diseases. For media enquiries at ACC, please contact: Elizabeth Park +44 (0) 7989 988440 or Elizabeth.Park@mslpr.co.uk Rob Jones +44 (0) 7768 637786 or Rob.Jones@mslpr.co.uk For media contacts outside of ACC, please contact: Denis Abbonato +44 (0) 207 878 3129 or Denis.Abbonato@mslpr.co.uk Note to Editor: The IDEA survey was sponsored by an unrestricted grant from sanofiaventis. References: 1 Haffner S on behalf of the IDEA Executive Committee. Waist circumference and Body Mass Index are both independently associated with cardiovascular disease. The International Day for the Evaluation of Abdominal Obesity (IDEA) survey. Abstract presentation at American College of Cardiology’s 55th Annual Scientific Session. 2006 2 Castro JP, El-Atat FA, McFarlane SI, Aneja A, Sowers JR. Cardiometabolic Syndrome: Pathophysiology And Treatment. Curr Hypertens Rep. 2003; 5: 393-401. 3 Matsuzawa Y, Funahashi T, Kihara S, Shimomura I. Adiponectin and Metabolic Syndrome. Arterioscler Thromb Vasc Biol. 2004; 24: 29-33. 4 Patel VB, Robbins MA, Topol EJ. C-Reactive Protein: A ‘Golden Marker’ For Inflammation And Coronary Artery Disease. Cleve Clin J Med. 2001; 68:521-534. Wajchenberg BL. Subcutaneous and visceral adipose tissue: their relation to the metabolic syndrome. 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World Heart Federation. Geneva c2004 [cited 7th February 2006]. Available from: http://www.worldheart.org/call-to-action-myths-facts.php 12 Rayner M & Petersen S. European Cardiovascular Disease Statistics. British Heart Foundation Health Promotion Research Group. Volume 4 2004.