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CARDS: The Collaborative Atorvastatin DiabetesStudy

PurposeTo assess the effectiveness of 10 mg atorvastatin daily in the primaryprevention 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 preventionof cardiovascular disease with atorvastatin in the CollaborativeAtorvastatin Diabetes Study (CARDS): multicentre randomisedplacebo-controlled trial. Lancet 2004;264:685696.

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CARDS: The Collaborative Atorvastatin DiabetesStudy

- TRIAL DESIGN -

Design

Multicenter, multinational, randomized, double-blind, parallel group

Patients

2838 patients aged 40-75 yrs with type 2 diabetes mellitus and atleast one of: hypertension, retinopathy, albuminuria, smoking.Patients with history of MI, angina, coronary vascular surgery,cerebrovascular accident or severe peripheral vascular diseaseineligible

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

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CARDS: The Collaborative Atorvastatin DiabetesStudy

- TRIAL DESIGN continued-

Baseline characteristicsAtorvastatin 10 mg

(n=1428)

Placebo

(n=1410)

Age (years) 62 62

Female 32% 32%Diabetes duration(years)

7.9 7.8

Hypertension 84% 84%

Retinopathy 30% 30%

Albuminuria 15% 15%

Current smoker 22% 23%

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CARDS: The Collaborative Atorvastatin DiabetesStudy

- RESULTS -

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

There was a favourable trend in the atorvastatin groupwith regard to all cause mortality, acute coronaryevents, coronary revascularization, and stroke

Adverse event rate similar in atorvastatin and placebogroups.

No cases of rhabdomyolysis.

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CARDS: The Collaborative Atorvastatin DiabetesStudy

- RESULTS continued -

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CARDS: The Collaborative Atorvastatin DiabetesStudy

- RESULTS continued -

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CARDS: The Collaborative Atorvastatin DiabetesStudy

- SUMMARY -

Atorvastatin (10 mg, once daily) is safe and effective inreducing the risk of cardiovascular events, including stroke, inpatients with type 2 diabetes

There was a favourable trend in the atorvastatin group withregard to all cause mortality, major coronary events, coronaryrevascularization, and stroke