- First ever specifically designed study of cholesterol lowering in patients with Type 2 diabetes, but without existing cardiovascular disease (CVD) 1
- Treatment with atorvastatin cut incidence of stroke by almost a half and reduced cardiovascular (CV) events by over a third 2
- Results may have major implications for how diabetes is managed in the UK
- Landmark UK study sponsored by Diabetes UK, Department of Health and Pfizer UK 1
Patients with Type 2 diabetes and a CV risk factor would benefit from a cholesterol-lowering medicine according to results from the first ever specifically designed UK primary prevention statin trial announced today at the American Diabetes Association (ADA)2.
CARDS, a unique collaboration between Diabetes UK, the Department of Health, Pfizer UK and co-ordintated by University College London, showed that 10mg atorvastatin (Lipitor) reduced cardiovascular (CV) events by 37% (p=0.01) in patients with diabetes without existing CVD2. Stroke, the third most common cause of death in the UK and the single biggest cause of disability among adults3, was substantially reduced by 48% (p=0.016)2.
"In this study, patients on atorvastatin experienced major CVD benefits – so much so that the trial was stopped early because it would be unfair to those receiving placebo to continue," commented Professor John Betteridge, CARDS investigator. "Currently, only patients with diabetes with elevated cholesterol or established heart disease routinely receive statins – but this study shows that even those without CVD or high cholesterol could benefit from cholesterol-lowering."
Simon O'Neill, Head of Information and Education at Diabetes UK added, "People with diabetes spend 1.1 million days in hospital in the UK every year. Two thirds of this time is as a result of cardiovascular disease, much of which could be prevented. Doctors should now consider all of their patients with diabetes for statin therapy."
CARDS stands for the Collaborative Atorvastatin Diabetes Study and was conducted in 132 centres across UK and Ireland1. A total of 2,838 patients with moderately elevated LDL-cholesterol and triglyceride levels were involved1. The study was designed to assess the effectiveness of lipid-lowering treatment (with atorvastatin 10 mg) for the primary prevention of CVD in Type 2 diabetes patients with additional risk factors for CVD1.
Patients on atorvastatin experienced large and significant reductions in CV events (defined as acute coronary events, stroke and CABG/other revascularisation procedures)2. The benefit to patients was observed irrespective of their LDL-cholesterol or triglyceride levels at the start of the study2.
The results of CARDS also reinforce the long-term safety profile of atorvastatin, with no differences in adverse events observed between patients on atorvastatin and placebo2.
For further information, please contact:
Nita Ares
Ketchum
Tel: 020 7424 1165
Mobile:07818421415
Bill Harnett
Diabetes UK
Tel: 020 7424 1165
bill.harnett@diabetes.org.uk
Dr Michael Zaiac
Pfizer Ltd
Tel: 01737 330 507
michael.zaiac@pfizer.com
Notes to editors
Atorvastatin is a prescription only medicine licensed in the UK to lower elevated total cholesterol, LDL-cholesterol and triglycerides in patients with high levels of blood cholesterol (hypercholesterolaemia) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin is currently not licensed for the prevention of coronary or cardiovascular events.
References
1. Colhoun, H.M, Thomason M.J., Mackness M.I., Maton S.M., Betteridge D.J., Durrington P.N., Hitman G.A., Neil H.A.W, Fuller, J.H. and the CARDS Investigators. Design of the Collaborative AtoRvastatin Diabetes Study (CARDS) in Patients with Type 2 Diabetes. Diabetic Medicine 2002, 19: 201-211.
2. Data on file.
3. National Service Framework. National Service Framework for Older People (Chapter Two, Standard Five). Department of Health, March 2001.