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 40โ75 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 4ยท14 mmol/L or lower, a fasting triglyceride amount of 6ยท78 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 3ยท9 years (IQR 3ยท0โ4ยท7). 127 patients allocated placebo (2ยท46 per 100 person-years at risk) and 83 allocated atorvastatin (1ยท54 per 100 person-years at risk) had at least one major cardiovascular event (rate reduction 37% [95% CI โ52 to โ17], p=0ยท001). 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% (โ55 to โ9), coronary revascularisations by 31% (โ59 to 16), and rate of stroke by 48% (โ69 to โ11). Atorvastatin reduced the death rate by 27% (โ48 to 1, p=0ยท059). 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.