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Odkazy a zdroje - Studie - CARDS



CARDS


Author(s)
(a) Colhoun HM, Thomason MJ, Mackness MI, Maton SM, Betteridge DJ, Durrington PN, Hitman GA, Neil HAW, Fuller JH, and the CARDS Investigators (b) Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HAW, Livingstone SJ, Thomason MJ, Mackness MI, Charlton-Menys V, Fuller JH

Title(s)
(a) Design of the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with Type 2 diabetes (b) Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial

Reference(s)
(a) Diabet Med 2002;19:201-11 (b) Lancet 2004;364:685–96

Disease
Diabetes mellitus

Purpose
To evaluate the effectiveness of lipid lowering with atorvastatin for the primary prevention of cardiovascular events in patients with type 2 diabetes

Study design
Randomised, double-blind, placebo-controlled

Follow-up
Median 3.9 years

Patients
2838 patients (1428 atorvastatin, 1410 placebo), mean age 62 years, with type 2 diabetes and one other risk factor for coronary heart disease, LDL cholesterol ≤ 160 mg/dl and triglycerides ≤ 600 mg/dl, without established coronary or cerebrovascular disease

Treatment regimen
Atorvastatin, 10 mg/day, or placebo

Concomitant therapy
-

Results
The primary endpoint of acute coronary heart disease events (MI including silent infarction, unstable angina pectoris, acute coronary heart disease death, resuscitated cardiac arrest), coronary revascularisation procedures, or stroke occurred in 5.8% of patients receiving atorvastatin and in 9.0% of those receiving placebo (p = 0.001)

Comments
The trial was terminated 2 years earlier than expected because the prespecified stopping rule for efficacy had been met