CARDS (Collaborative AtoRvastatin Diabetes Study) was sponsored by the charity Diabetes UK, the Department of Health and Pfizer. The study found that a daily 10mg dose of atorvastatin reduced the risk of a major cardiovascular event by 37%; for instance, serious heart problems were reduced by more than one third (36%) and strokes by almost half (48%). Importantly, these benefits were observed even amongst patients whose LDL-cholesterol levels were already quite low before treatment.
Professor John Betteridge, CARDS co-principal investigator and Professor of Endocrinology and Metabolism at UCL, says: "This exciting study has very important implications for the cardiovascular health of people with Type 2 diabetes. For all patients with Type 2 diabetes consideration should now be given to whether they warrant statin therapy. What this study shows is in this case, atorvastatin treatment is safe and highly effective at reducing the risk of cardiovascular disease."
The trial, co-ordinated at UCL, was carried out in 132 centres in the UK and Ireland and involved 2,838 people with Type 2 diabetes, each taking a daily dose of 10mg of atorvastatin or placebo. Participants entered CARDS with no previous history of heart disease or stroke, but with some cardiovascular risk factors other than diabetes and with relatively low levels of cholesterol.
The study was due to run until 2005 but was stopped in June 2003 when interim results showed a significant reduction in the risk of heart attacks, strokes or the need for cardiovascular surgery in participants taking atorvastatin.
There are 1.4 million people in the UK diagnosed with diabetes. People with Type 2 diabetes (the most common form of the disease) are at significantly increased risk of developing cardiovascular disease compared to people without diabetes.
CARDS is the first clinical trial specifically designed to investigate the effectiveness of cholesterol lowering with a statin in people with Type 2 diabetes who have no previous history of heart disease or stroke.
Paper describing the design of CARDS available at: http://www.blackwell-synergy.com/
Baseline data - the characteristics of patients entering the study - will be published in the journal Diabetic Medicine in July.
The main results of the study will be published later this year.
See the CARDS Website www.cardstrial.org for further information.
CARDS Executive Committee
Professor John Betteridge,* University College London
Professor Helen Colhoun,* CARDS Co-ordinating Centre, University College London
Professor Paul Durrington,* CARDS Central Laboratory, University of Manchester
Professor John Fuller,* CARDS Co-ordinating Centre, University College London
Professor Graham Hitman,* Barts and The London, Queen Mary's School of Medicine & Dentistry
Ms Dot Lambert, Department of Health - Study Sponsor
Dr Moira Murphy, Diabetes UK - Study Sponsor
Dr Andrew Neil,* University of Oxford Dr Craig Stevenson, Pfizer UK Ltd - Study Sponsor
* Co-principal investigator
For more information, please contact:
Jenny Gimpel (University College London Press Office) on tel 44-207-679-9739, Mobile 44-799-067-5947