Collaborative Atorvastatin Diabetes Study (CARDS) - Lipids Online

Collaborative Atorvastatin Diabetes Study (CARDS)
Commentary by Harold Bays, MD, FACP
CARDS: Patient Baseline Characteristics
Age
Mean (SD) years
70
Placebo
(n = 1410)
61.8 (8.0)
529 (38%)
708 (50%)
173 (12%)
Women
453 (32%)
White ethnicity
1326 (94%)
BMI
Mean (SD), kg/m 2 28.8 (3.5)
Obese (BMI >30 kg/m 2 ) 538 (38%)
Atorvastatin
(n = 1428)
61.5 (8.3)
558 (39%)
703 (49%)
167 (12%)
456 (32%)
1350 (95%)
28.7 (3.6)
515 (36%)
Colhoun HM et al. Lancet 2004;364:685-696.
Reprinted with permission from Elsevier.
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Key Points
The Collaborative Atorvastatin Diabetes Study (CARDS) was a multicenter, randomized, placebocontrolled,
4-year, double-blind trial of atorvastatin 10 mg/day that was the first to evaluate statin therapy
prospectively and specifically in patients with type 2 diabetes. Study participants were patients aged 40–75
years with type 2 diabetes, low-density lipoprotein cholesterol (LDL-C) concentration 160 mg/dL or less,
fasting triglycerides 600 mg/dL or less, and at least one additional risk factor (hypertension, retinopathy,
microalbuminuria or macroalbuminuria, or current smoking) but no history of CHD, cerebrovascular
accident, or severe peripheral vascular disease. Randomization was completed in June 2001. Follow-up was
initially planned to be endpoint driven, concluding after the occurrence of 304 primary endpoints.
However, as a result of a significant benefit demonstrated by atorvastatin at an interim analysis, the
independent steering committee of CARDS stopped the trial earlier than planned, after 149 primary
endpoints.
Of 4053 subjects screened, 3249 (80%) entered baseline assessment, and 2838 (70%) were randomized;
1410 subjects were allocated placebo (1398 [99.1%] of whom completed follow-up) and1428 to
atorvastatin 10 mg/day (1421 [99.5%] of whom completed follow-up). The median time of follow-up was
3.9 years. Baseline characteristics were similar between treatment groups. During the course of the study,
some placebo group subjects were administered nonstudy statin. The percentage of patients taking at least
one lipid-lowering drug (including atorvastatin) in the atorvastatin group was 90%, 87%, 86%, and 78% at
years 1, 2, 3, and 4, respectively, with an average of 85% atorvastatin use over the duration of the study.
The percentage of patients taking at least one lipid-lowering drug in the placebo group was 2%, 7%, 12%,
and 15% at years 1, 2, 3, and 4, respectively, with an average of 9% nonstudy drug use over the duration of
the study.
The group treated with atorvastatin 10 mg/day had an average 26% (54 mg/dL) reduction in total
cholesterol and 40% (46 mg/dL) reduction in LDL-C. The average reduction in triglyceride levels was
19%, with a 1% increase in HDL-C levels compared with placebo.
The relative risk reduction in the primary endpoint of first acute CHD event (MI including silent infarction,
unstable angina, acute CHD death, resuscitated cardiac arrest), coronary revascularization procedures, or
Collaborative Atorvastatin Diabetes Study (CARDS)
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