CARDS: The Collaborative Atorvastatin Diabetes Study

Purpose To assess the effectiveness of 10 mg atorvastatin daily in the primary prevention of cardiovascular disease in patients with type 2 diabetes, but without high concentrations of LDL-cholesterol Reference Colhoun HM, Betteridge PN, Hitman GA et al. Primary prevention of cardiovascular disease with atorvastatin in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;264:685696.

CARDS: The Collaborative Atorvastatin Diabetes Study - TRIAL DESIGN Design Multicenter, multinational, randomized, double-blind, parallel group
Patients 2838 patients aged 40-75 yrs with type 2 diabetes mellitus and at least one of: hypertension, retinopathy, albuminuria, smoking. Patients with history of MI, angina, coronary vascular surgery, cerebrovascular accident or severe peripheral vascular disease ineligible Follow up and primary endpoint Primary endpoint: acute coronary event, coronary revascularization, or stroke. Median 3.9 years follow-up Treatment Atorvastatin 10 mg per day or placebo

CARDS: The Collaborative Atorvastatin Diabetes Study - TRIAL DESIGN continuedBaseline characteristics
Atorvastatin 10 mg (n=1428) Age (years) Female Diabetes duration (years) Hypertension Retinopathy Albuminuria Current smoker 62 32% 7.9 84% 30% 15% 22% Placebo (n=1410) 62 32% 7.8 84% 30% 15% 23%

CARDS: The Collaborative Atorvastatin Diabetes Study - RESULTS -

Compared with placebo, patients receiving 10 mg atorvastatin daily showed a 37% reduction in major cardiovascular events from 9.0% to 5.8 % (p = 0.001)

There was a favourable trend in the atorvastatin group with regard to all cause mortality, acute coronary events, coronary revascularization, and stroke
Adverse event rate similar in atorvastatin and placebo groups. No cases of rhabdomyolysis.

CARDS: The Collaborative Atorvastatin Diabetes Study - RESULTS continued -

CARDS: The Collaborative Atorvastatin Diabetes Study - RESULTS continued Breakdown of primary endpoint by treatment
Type of first event Fatal myocardial infarction Other acute coronary heart disease death Non-fatal MI Unstable angina Resuscitated cardiac arrest Coronary revascularization Fatal stroke Non-fatal stroke Total Atorvastatin 10 mg (n=1428) 89 10 25 7 0 12 1 20 83 Placebo (n=1410) 20 4 41 9 0 18 5 30 127

CARDS: The Collaborative Atorvastatin Diabetes Study - RESULTS continued -

CARDS: The Collaborative Atorvastatin Diabetes Study - SUMMARY -

Atorvastatin (10 mg, once daily) is safe and effective in reducing the risk of cardiovascular events, including stroke, in patients with type 2 diabetes There was a favourable trend in the atorvastatin group with regard to all cause mortality, major coronary events, coronary revascularization, and stroke