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The CARDS Investigators: Primary Prevention of Cardiovascular Disease With Atorvastatin in Type 2 Diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): Multicentre Randomised Placebo- Controlled Trial

Posted on: Wednesday, 9 February 2005, 03:00 CST

Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HA, Livingstone SJ, Thomason MJ, Mackness MI, Charlton-Menys V, Fuller JH, the CARDS Investigators: Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo- controlled trial. Lancet 364:685-696, 2004

Findings. This randomized trial in 2,838 patients aged 40-75 years assessed the effectiveness of 10 mg atorvastatin daily compared with placebo for primary prevention of major cardiovascular events in patients with type 2 diabetes without high concentrations of LDL cholesterol. At entry, the patients had no previous history of cardiovascular disease, an LDL cholesterol concentration of ≤4.14 mmol/l (160 mg/dl), a fasting triglyceride concentration of ≤6.78 mmol/l (600 mg/dl), and at least one of the following: retinopathy, albuminuria, current smoking, or hypertension. The primary end point was time to first occurrence of either acute coronary heart disease events, coronary revascularization, or stroke. The average LDL cholesterol and triglyceride concentrations at baseline were 117 and 149 mg/dl, respectively. The trial was terminated 2 years earlier than expected because the prespecified early stopping rule for efficacy had been met. Median duration of follow-up was 3.9 years. A total of 127 patients allocated placebo (2.46 per 100 person-years at risk) and 83 allocated atorvastatin (1.54 per 100 person-years at risk) had at least one major cardiovascular event (rate reduction 37% [95% CI - 52 to -17], P = 0.001). Treatment would be expected to prevent at least 37 major vascular events per 1,000 of such people treated for 4 years. Assessed separately, acute coronary heart disease events were reduced by 36% (-55 to -9%), coronary revascularizations by 31% ( -59 to 16%), rate of stroke by 48% (-69 to -11%), and the death rate by 27% (-48 to 1%, P = 0.059). No excess of adverse events was noted in the atorvastatin group.

Significance. Type 2 diabetes is associated with a substantially increased risk of cardiovascular disease. The role of lipid- lowering therapy with statins for the primary prevention of cardiovascular disease in diabetes has only recently been determined by this study and the Heart Protection Study (using 40 mg/day simvastatin). The plasma lipid levels at the start of this study would have been insufficient to start statin therapy according to guidelines existing at that time. This study demonstrated that 10 mg atorvastatin daily is safe and efficacious in reducing the risk of a first cardiovascular disease event, including stroke, in patients with type 2 diabetes without high LDL cholesterol.

Impact. It may be appropriate for most patients with type 2 diabetes who are >40 years of age to receive therapy with a statin.

Copyright American Diabetes Association Feb 2005

Source: Diabetes Care

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