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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
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.
About Diabetes
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:
About AstraZeneca
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.


Emily Denney, AstraZeneca LP, +1-302-885-3451, Sarah
Hills, EGIR, Tel +39-050-55-24-65,