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Statin therapy recommended for all patients with diabetes, regardless of cholesterol levels.
Cholesterol-lowering therapy (statins) reduce the risk of macrovascular events for people with diabetes, even if they do not have manifest coronary disease or elevated cholesterol levels, researchers report.
Myocardial infarction and stroke are common causes of major morbidity and mortality in people with diabetes. However, blood concentrations of total and LDL cholesterol in these patients are similar to the general population, so most do not receive cholesterol-lowering therapy despite their elevated risk.
The Heart Protection Study Collaborative Group, Oxford, United Kingdom, has conducted a study to address whether diabetics without symptomatic coronary diseases may benefit from LDL cholesterol reduction.
In a randomized trial, 5963 diabetics patients (mean age, 62.1; males, 70%) and 14,573 high-risk patients without diagnosed diabetes (mean age, 64.7, males, 78%) received either 40 mg simvastatin or placebo daily over a five-year period. At baseline, the mean total LDL cholesterol was 3.2 mmol/L for the diabetes group and 3.4 mmol/L for the non-diabetes group. The simvastatin-allocated participants (both diabetic and non-diabetic) showed a 1.0-mmol/L average reduction in LDL cholesterol compared to those receiving the placebo during the treatment period.
Among the participants with diabetes, allocation to simvastatin produced a 22% (95% CI 13-39, p<0.0001) proportional reduction in the first occurrence of any major vascular event, including major coronary events, strokes and revascularizations. This reduction was similar to that observed for the other high-risk participants (24%, 95% CI 19-28, p<0.0001).
The researchers also report a highly significant 33% (95% CI 17-46, p=0.0003) proportional reduction in first major vascular events among the 2912 diabetic patients who did not have any diagnosed coronary or other occlusive arterial disease at study entry, and a 27% (95% CI 13-40, p=0.0007) proportional reduction among the 2426 diabetic participants whose pre-treatment measurements of LDL cholesterol were below 3.0 mmol/L.
The proportional risk reductions among all diabetic participants appeared to be approximately a quarter irrespective of sex, age, blood creatinine concentration, treatment for hypertension, or body size at study entry.
The researchers conclude these results represent “definitive evidence that cholesterol-lowering statin therapy can produce substantial reductions in the risk of heart attacks, of strokes, and of revascularizations in people with diabetes, even if they do not already have diagnosed coronary or other occlusive arterial disease.”
They recommend that, “statin therapy should now be considered routinely for all diabetic patients at sufficiently high risk of such major vascular event, irrespective of their initial cholesterol concentrations.” Lancet 2003 Jun 14;361:9374:2005-2016.
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