2004-09-03

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 of1,200 subjects has been reached in the Relationship between InsulinSensitivity and Cardiovascular disease risk (RISC) study - thelargest study using the euglycaemic clamp technique to date toexamine 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 inFebruary 2002, involves 14 European countries and is expected topublish initial results by 2005.

The RISC study has three main objectives: 1) to establish whetherinsulin resistance predicts the deterioration of CVD risk markers,diabetes, obesity, atherosclerosis, dyslipidaemia, and CVD; 2) toanalyse genetic and environmental contributions to insulin resistanceand CVD; and 3) to develop an uncomplicated method for identifyinginsulin resistant patients in clinical practice. Insulin resistanceis a core metabolic dysfunction associated with type 2 diabetes andincreased risk of heart disease and stroke. The condition is a resultof the body's inability to respond effectively to the insulin thebody produces, and is associated with blood lipid imbalances, such asan increased prevalence of small low-density lipoprotein (LDLcholesterol) particles, low levels of high-density lipoprotein (HDLcholesterol), and increased levels of triglycerides, all of which cancause atherosclerosis.

"It is estimated that millions of people in the world have insulinresistance, which is strongly linked to the development of futurecomplications such as type 2 diabetes and, possibly, CVD," said EleFerrannini, MD, Department of Internal Medicine, University of PisaSchool of Medicine, Pisa, Italy. "While theories have been proposed,evidence is lacking as to the role of insulin resistance as anindependent and direct cardiovascular risk factor. The RISC studyseeks to provide more definitive evidence of this link, which canthen be applied to current treatment strategies for these patients."

"People who suffer from type 2 diabetes are at a higher risk forcardiovascular disease-in fact, a person with type 2 diabetes sharesthe same increased risk as someone who has already suffered from aprevious heart attack. The prevalence of coronary heart disease,heart attacks and stroke is threefold higher in people with metabolicsyndrome 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 advancecurrent 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 theinfrastructure of an extended European collaborative research group,the RISC study will examine people thirty to sixty years of age at 19centres 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 beresponsible for up to 17 million deaths annually while the number ofpeople with diabetes is expected to grow to 333 million worldwide by2025," said Alain Vanvossel, Head of Unit "Major Diseases" in theDirectorate General for Research at the European Commission inBrussels. "Research into the growing diabetes epidemic, and itsconnection to CVD, is critical to the health of our countries."

EGIR

The European Group for the Study of Insulin Resistance (EGIR) wasformed in 1992 by a group of investigators from different researchbackgrounds 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 projectfrom euglycaemic hyperinsulinaemic clamp experiments performed in 21centres across Europe. This unique database has now produced 11publications.

AstraZeneca's commitment to type 2 diabetes

AstraZeneca is committed to the research and development ofinnovative treatments designed to decrease the risk, prevalence andimpact of CVD, including type 2 diabetes. According to theInternational Diabetes Federation, an estimated 194 million peopleworldwide were afflicted with diabetes in 2003 and that number wasexpected to increase to 333 million by 2025. The World HealthOrganization (WHO) and the IDF estimate 3.2 million deaths can beattributed to diabetes each year. More than 65 per cent of deaths indiabetes patients are attributed to heart and vascular disease. Tothat end, AstraZeneca is researching new treatment options for type 2diabetes and other metabolic disorders.

EU

The research financed by the European Union aims at contributingto fighting the diabetes tide as well as related diseases, mainlyobesity and metabolic syndrome. For diabetes research only, in the EUFifth Framework programme (1998-2002), 22 research projects(including RISC) have been funded with an EU contribution of morethan 42 million Euros. These projects address several aspects ofdiabetes, such as fundamental genomics, applied biotechnology,nutrition and obesity, and public health factors. In addition, theobjective of diabetes research in the sixth Framework Programme(2003-2006) is to develop improved strategies for the prevention andmanagement of diabetes. The emphasis is put on translational researchaimed at bridging basic knowledge and clinical application.

About Diabetes

Diabetes has enormous health and cost implications across theworld. Diabetes is the fourth leading cause of death in mostdeveloped countries. There are several important long-termcomplications of diabetes. Type 2 diabetes is a progressive disorderas the combined effects of a decreased response to insulin andpancreatic cell dysfunction mean that blood glucose control becomesincreasingly difficult. Over time, this can seriously damage theheart and circulation, nerves, eyes and kidneys. People with diabetesalso develop cardiovascular complications at an earlier age, are twoto four times more likely to suffer strokes, and about 73 per cent ofadults with diabetes are considered prehypertensive. Given the highprevalence of diabetes, and thus the high numbers of complicationsseen, this disease is a huge drain on economic resources claiming onaverage 8 per cent of national healthcare budgets in developedcountries. Type 2 diabetes is by far the most common form ofdiabetes, accounting for approximately 90 per cent of all diabetescases worldwide.

Notes to Editors:

About AstraZeneca

Through its 40 years of cardiovascular experience, AstraZeneca hasdeveloped a robust portfolio of products for high cholesterol, highblood pressure and heart failure. AstraZeneca is committed toresearching and developing innovative treatments and aims to expandits range of CV products into the areas of type 2 diabetes andmetabolic syndrome, dyslipidemia, vascular disease prevention,thromboembolism and atrial fibrillation.

AstraZeneca is a major international healthcare business engagedin the research, development, manufacture and marketing ofprescription pharmaceuticals and the supply of healthcare services.It is one of the top pharmaceutical companies in the world withhealthcare sales of over US$18.8 billion and leading positions insales of cardiovascular, gastrointestinal, oncology, neuroscience andrespiratory products.

ots Originaltext: AstraZeneca LPIm Internet recherchierbar: http://www.presseportal.de

Contact:Emily Denney, AstraZeneca LP, +1-302-885-3451, egirpisa@tin.it. SarahHills, EGIR, Tel +39-050-55-24-65, emily.denney@astrazeneca.com

AstraZeneca LP

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