| Authors |
| Colhoun HM, Betteridge DJ, Durrington PN, et al. |
| Title |
| Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial |
| References |
| Lancet. 2004 Aug 21-27;364(9435):685-96. |
| Background |
| Type 2 diabetes is associated with a substantially increased risk of cardiovascular disease, but the role of lipid-lowering therapy with statins for the primary prevention of cardiovascular disease in diabetes is inadequately defined. |
| Purpose |
| To assess the effectiveness of atorvastatin 10 mg daily for primary prevention of major cardiovascular events in patients with type 2 diabetes without high concentrations of LDL-cholesterol. |
| Design |
- Multicenter, randomized, double-blind, placebo controlled trial
- 2938 patients, aged 40-75 with DMII at least 6 months prior to study entry
- Had one of (hypertension, retinopathy, microalbuminuria, current smoker)
- LDL-C <4.14 mmol/L
- Triglycerides <6.78 mmol/L
|
| Exclusion Criteria |
- History of myocardial infarction, angina, CABG, stroke, PVD
- Creatinine>150 umol/L
- HbA1c >12%
|
| Follow-Up |
| Median 4.0 years (3.0-4.7 years) |
| Treatment Regimen |
- Atorvastatin 10mg/day or placebo
- Follow-up monthly for first 3 months, then at 6months, and thereafter 6 monthly. Compliance assessed as well as routine bloodwork and clinical outcomes
|
| Results |
|
Primary Endpoints
Atorvastatin
n=1428 |
Placebo
n=1410 |
Hazard Ratio |
p |
| Combined |
| 5.8% |
9.0% |
0.63 (0.48-0.83) |
0.001 |
| Acute coronary events |
| 3.6% |
5.5% |
0.64 (0.45-0.91) |
0.02 |
| Coronary revascularization |
| 1.7% |
2.4% |
0.69 (0.41-1.16) |
0.2 |
| Stroke |
| 1.5% |
2.8% |
0.52 (0.31-0.89) |
0.02 |
Secondary Endpoints - Death from any cause non-significantly reduced in atorvastatin group by 27%; p=0.059
- Any acute cardiovascular disease event reduced in atorvastatin group by 32%; p=0.001
|
| Summary |
| Atorvastatin 10 mg daily is safe and efficacious in reducing the risk of first cardiovascular disease events, including stroke, in patients with type 2 diabetes with at least 1 additional risk factor without a high LDL-cholesterol. |