Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial - PubMed (original) (raw)
Clinical Trial
Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial
Helen M Colhoun et al. Lancet. 2004 Aug.
Abstract
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. We aimed 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.
Methods: 2838 patients aged 40-75 years in 132 centres in the UK and Ireland were randomised to placebo (n=1410) or atorvastatin 10 mg daily (n=1428). Study entrants had no documented previous history of cardiovascular disease, an LDL-cholesterol concentration of 4.14 mmol/L or lower, a fasting triglyceride amount of 6.78 mmol/L or less, and at least one of the following: retinopathy, albuminuria, current smoking, or hypertension. The primary endpoint was time to first occurrence of the following: acute coronary heart disease events, coronary revascularisation, or stroke. Analysis was by intention to treat.
Findings: The trial was terminated 2 years earlier than expected because the prespecified early stopping rule for efficacy had been met. Median duration of follow-up was 3.9 years (IQR 3.0-4.7). 127 patients allocated placebo (2.46 per 100 person-years at risk) and 83 allocated atorvastatin (1.54 per 100 person-years at risk) had at least one major cardiovascular event (rate reduction 37% [95% CI -52 to -17], p=0.001). Treatment would be expected to prevent at least 37 major vascular events per 1000 such people treated for 4 years. Assessed separately, acute coronary heart disease events were reduced by 36% (-55 to -9), coronary revascularisations by 31% (-59 to 16), and rate of stroke by 48% (-69 to -11). Atorvastatin reduced the death rate by 27% (-48 to 1, p=0.059). No excess of adverse events was noted in the atorvastatin group.
Interpretation: 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 without high LDL-cholesterol. No justification is available for having a particular threshold level of LDL-cholesterol as the sole arbiter of which patients with type 2 diabetes should receive statins. The debate about whether all people with this disorder warrant statin treatment should now focus on whether any patients are at sufficiently low risk for this treatment to be withheld.
Comment in
- Statins for all patients with type 2 diabetes: not so soon.
Garg A. Garg A. Lancet. 2004 Aug 21-27;364(9435):641-2. doi: 10.1016/S0140-6736(04)16907-9. Lancet. 2004. PMID: 15325810 No abstract available. - Statins for patients with type 2 diabetes.
Auer J, Berent R, Weber T, Eber B. Auer J, et al. Lancet. 2004 Nov 27-Dec 3;364(9449):1933-4. doi: 10.1016/S0140-6736(04)17464-3. Lancet. 2004. PMID: 15566997 No abstract available. - Statins for patients with type 2 diabetes.
Pimpinella G, Bertini Malgarini R, Martini N. Pimpinella G, et al. Lancet. 2004 Nov 27-Dec 3;364(9449):1933; author reply 1933. doi: 10.1016/S0140-6736(04)17462-X. Lancet. 2004. PMID: 15566999 No abstract available. - Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes.
Clearfield M. Clearfield M. Curr Atheroscler Rep. 2005 Feb;7(1):7-8. Curr Atheroscler Rep. 2005. PMID: 15683592 No abstract available. - CARDS and A to Z.
Liebson PR. Liebson PR. Prev Cardiol. 2005 Winter;8(1):59-62. doi: 10.1111/j.1520-037x.2005.4002.x. Prev Cardiol. 2005. PMID: 15722696 No abstract available. - Atorvastatin reduced major cardiovascular disease events in type 2 diabetes mellitus.
Gami AS, Smith SA. Gami AS, et al. ACP J Club. 2005 Mar-Apr;142(2):29. ACP J Club. 2005. PMID: 15739976 No abstract available. - Statins and CVD prevention in the diabetic population: implications of the CARDS trial.
Murad O, Palmer J, Sowers J, McFarlane SI. Murad O, et al. Curr Diab Rep. 2005 Jun;5(3):191-3. doi: 10.1007/s11892-005-0008-1. Curr Diab Rep. 2005. PMID: 15929865 Review. No abstract available.
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