Collaborative Atorvastatin Diabetes Study (CARDS) - Lipids Online

Collaborative Atorvastatin Diabetes Study (CARDS)
Commentary by Harold Bays, MD, FACP
CARDS: Effect of Atorvastatin on the Primary
Endpoint: Major CV Events Including Stroke
Cumulative Hazard, (%)
Placebo
Atorvastatin
15
10
5
Relative Risk Reduction 37% (95% CI, 17–52)
P = 0.001
Placebo
127 events
0
0 1 2 3 4
Years
1410
1428
1351
1392
Colhoun HM et al. Lancet 2004;364:685-696.
Reprinted with permission from Elsevier.
1306
1361
1022
1074
Atorvastatin
83 events
651
694
4.75
305
328
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CARDS: Adverse and Serious Adverse Events
Type of Event
Serious adverse event
possibly associated
with study drug
Discontinued for AE
Rhabdomyolysis
Myopathy AE report
CPK ≥10 × ULN
ALT ≥3 × ULN
AST ≥3 × ULN
Patients (%) with Event
Placebo
(n = 1410)
20 (1.1%)
145 (10%)
0
1 (0.1%)
10 (0.7%)
14 (1%)
4 (0.3%)
Atorvastatin 10 mg
(n = 1428)
19 (1.1%)
122 (9%)
0
1 (0.1%)
2 (0.1%)
17 (1%)
6 (0.4%)
Colhoun HM et al. Lancet 2004;364:685-696.
Slide Source:
Lipids Online Slide Library
www.lipidsonline.org
Implications and Clinical Relevance
CARDS showed that in patients with type 2 diabetes mellitus with lower LDL-C levels, atorvastatin 10 mg
daily was safe, well tolerated, and significantly efficacious in reducing the risk of first CHD events.
CARDS supports recommendations such as that made by the American Diabetes Association that patients
with type 2 diabetes mellitus should be considered as candidates for statin treatment—even at lower LDL-C
levels. Subgroup analysis revealed that irrespective of whether the baseline LDL-C was at or above, or
below the median of 120 mg/dL, atorvastatin patients in both subgroups had similar relative risk reductions
of 37–38% for the primary endpoint.
Previous support for the benefits of statin therapy in diabetes patients had been derived from the
extrapolation of data from primary and secondary CHD prevention trials that included nondiabetic
populations. Because CARDS was the first study to evaluate statin therapy prospectively and specifically
in patients with type 2 diabetes mellitus, and because it was one of the few primary prevention trials
Collaborative Atorvastatin Diabetes Study (CARDS)
Baylor College of Medicine, Houston, Texas Page 4 of 5