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New European Study Examines the Role of Insulin Resistance in Predicting Cardiovascular Disease
London and Brussels (ots/PRNewswire) -
- RISC Study, Largest of its Kind, Reaches Recruitment Milestone
The European Group for the study of Insulin Resistance (EGIR) announced today that the clinical trial recruitment milestone of 1,200 subjects has been reached in the Relationship between Insulin Sensitivity and Cardiovascular disease risk (RISC) study - the largest study using the euglycaemic clamp technique to date to examine whether insulin resistance predicts cardiovascular disease (CVD), as well as future development of type 2 diabetes. This study, co-sponsored by the European Union (EU) and AstraZeneca, began in February 2002, involves 14 European countries and is expected to publish initial results by 2005.
The RISC study has three main objectives: 1) to establish whether insulin resistance predicts the deterioration of CVD risk markers, diabetes, obesity, atherosclerosis, dyslipidaemia, and CVD; 2) to analyse genetic and environmental contributions to insulin resistance and CVD; and 3) to develop an uncomplicated method for identifying insulin resistant patients in clinical practice. Insulin resistance is a core metabolic dysfunction associated with type 2 diabetes and increased risk of heart disease and stroke. The condition is a result of the body's inability to respond effectively to the insulin the body produces, and is associated with blood lipid imbalances, such as an increased prevalence of small low-density lipoprotein (LDL cholesterol) particles, low levels of high-density lipoprotein (HDL cholesterol), and increased levels of triglycerides, all of which can cause atherosclerosis.
"It is estimated that millions of people in the world have insulin resistance, which is strongly linked to the development of future complications such as type 2 diabetes and, possibly, CVD," said Ele Ferrannini, MD, Department of Internal Medicine, University of Pisa School of Medicine, Pisa, Italy. "While theories have been proposed, evidence is lacking as to the role of insulin resistance as an independent and direct cardiovascular risk factor. The RISC study seeks to provide more definitive evidence of this link, which can then be applied to current treatment strategies for these patients."
"People who suffer from type 2 diabetes are at a higher risk for cardiovascular disease-in fact, a person with type 2 diabetes shares the same increased risk as someone who has already suffered from a previous heart attack. The prevalence of coronary heart disease, heart attacks and stroke is threefold higher in people with metabolic syndrome than in those without the syndrome," said Gunnar Olsson, MD, Vice President, Cardiovascular Therapeutic Area, AstraZeneca. "Through AstraZeneca's support of the RISC study, we hope to advance current research and gain a better understanding of type 2 diabetes, metabolic syndrome, and their link to CVD."
RISC is a prospective (three- and 10-year follow-up), observational, cohort study of more than 1,200 patients. Using the infrastructure of an extended European collaborative research group, the RISC study will examine people thirty to sixty years of age at 19 centres in 14 countries including Austria, Denmark, Finland, France, Germany, Greece, Holland, Ireland, Italy, Sweden, Spain, Switzerland, United Kingdom and Serbia and Montenegro.
"The twin epidemics of CVD and diabetes are escalating: CVD may be responsible for up to 17 million deaths annually while the number of people with diabetes is expected to grow to 333 million worldwide by 2025," said Alain Vanvossel, Head of Unit "Major Diseases" in the Directorate General for Research at the European Commission in Brussels. "Research into the growing diabetes epidemic, and its connection to CVD, is critical to the health of our countries."
The European Group for the Study of Insulin Resistance (EGIR) was formed in 1992 by a group of investigators from different research backgrounds interested in epidemiology, endocrinology, basic science, and public health-all of whom were interested in insulin resistance. The first combined activity of the group was a data-pooling project from euglycaemic hyperinsulinaemic clamp experiments performed in 21 centres across Europe. This unique database has now produced 11 publications.
AstraZeneca's commitment to type 2 diabetes
AstraZeneca is committed to the research and development of innovative treatments designed to decrease the risk, prevalence and impact of CVD, including type 2 diabetes. According to the International Diabetes Federation, an estimated 194 million people worldwide were afflicted with diabetes in 2003 and that number was expected to increase to 333 million by 2025. The World Health Organization (WHO) and the IDF estimate 3.2 million deaths can be attributed to diabetes each year. More than 65 per cent of deaths in diabetes patients are attributed to heart and vascular disease. To that end, AstraZeneca is researching new treatment options for type 2 diabetes and other metabolic disorders.
The research financed by the European Union aims at contributing to fighting the diabetes tide as well as related diseases, mainly obesity and metabolic syndrome. For diabetes research only, in the EU Fifth Framework programme (1998-2002), 22 research projects (including RISC) have been funded with an EU contribution of more than 42 million Euros. These projects address several aspects of diabetes, such as fundamental genomics, applied biotechnology, nutrition and obesity, and public health factors. In addition, the objective of diabetes research in the sixth Framework Programme (2003-2006) is to develop improved strategies for the prevention and management of diabetes. The emphasis is put on translational research aimed at bridging basic knowledge and clinical application.
Diabetes has enormous health and cost implications across the world. Diabetes is the fourth leading cause of death in most developed countries. There are several important long-term complications of diabetes. Type 2 diabetes is a progressive disorder as the combined effects of a decreased response to insulin and pancreatic cell dysfunction mean that blood glucose control becomes increasingly difficult. Over time, this can seriously damage the heart and circulation, nerves, eyes and kidneys. People with diabetes also develop cardiovascular complications at an earlier age, are two to four times more likely to suffer strokes, and about 73 per cent of adults with diabetes are considered prehypertensive. Given the high prevalence of diabetes, and thus the high numbers of complications seen, this disease is a huge drain on economic resources claiming on average 8 per cent of national healthcare budgets in developed countries. Type 2 diabetes is by far the most common form of diabetes, accounting for approximately 90 per cent of all diabetes cases worldwide.
Notes to Editors:
Through its 40 years of cardiovascular experience, AstraZeneca has developed a robust portfolio of products for high cholesterol, high blood pressure and heart failure. AstraZeneca is committed to researching and developing innovative treatments and aims to expand its range of CV products into the areas of type 2 diabetes and metabolic syndrome, dyslipidemia, vascular disease prevention, thromboembolism and atrial fibrillation.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top pharmaceutical companies in the world with healthcare sales of over US$18.8 billion and leading positions in sales of cardiovascular, gastrointestinal, oncology, neuroscience and respiratory products.
ots Originaltext: AstraZeneca LP
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