Statins (a class of cholesterol-lowering drugs) have proven efficacy in reducing cardiovascular risk, even among people with normal cholesterol concentrations; however their effect on people with diabetes has not been proven, and people with diabetes do not generally receive cholesterol-lowering therapy despite their increased risk of cardiovascular disease.
As part of the UK Heart Protection Study led by Rory Collins and colleagues from the Clinical Trial Service Unit, Oxford, UK, around 6000 people with diabetes (of whom 10% had type 1 disease) and around 14,500 people with occlusive arterial disease (who were not diabetic) were randomly allocated to receive 40 mg simvastatin daily or placebo.
Both groups of patients had their risk of primary outcomes ( one or more of cardiac death, non-fatal heart attack, stroke, coronary revascularisation) reduced by around 25% compared with those given placebo. The reduction in risk appeared to be greater (33%) among diabetic patients who did not have occlusive arterial disease (around half of people in the diabetes group). Risk reductions of around a quarter were found among patients with different duration, type, or control of diabetes, among older people (those aged over 65 years at study entry), among patients with high blood pressure, and among those with below-average cholesterol levels.
Rory Collins comments: "The present study provides direct evidence that cholesterol-lowering therapy is beneficial for people with diabetes even if they do not already have manifest coronary disease or high cholesterol concentrations. Statin therapy should now be considered routinely for all diabetic patients at sufficiently high risk of major vascular events, irrespective of their initial cholesterol concentrations."
In an accompanying Commentary (p 2000), Lars Lindholm from Umea University, Sweden, concludes: "Current guidelines for diabetes emphasise the importance of good glycaemic control as well as good blood-pressure control for all diabetic patients, but do not generally recommend starting statin therapy unless serum cholesterol concentrations are increased (eg, LDL cholesterol above 3•0 or 3•4 mmol/L). The use of statins is not common even in high-risk patients with type 2 diabetes and with hypertension and left ventricular hypertrophy participating in clinical trials. In the diabetic patients of the Losartan Intervention For Endpoint reduction in hypertension study (LIFE), for instance, the use of statins at baseline was below 10%, increasing to only 30% during the trial. Against this background, it is interesting that the investigators of the elegant HPS-diabetes paper now suggest that statin therapy should be considered routinely for all diabetic patients at sufficiently high risk of major vascular events, irrespective of their initial cholesterol values. Since all the studies discussed above came out favourably for statin use in diabetic patients (also the ones where this was not significant), one could go a step further and ask whether all patients with type 2 diabetes should be given a statin, regardless of their cholesterol value. This prescription may now be possible after the dramatic drop in the cost of simvastatin since it came off patent in several countries."
Contact:
Margaret Willson, MW Communications;
T) 44-0-1536-772181;
M) 44-0-7973-853347;
E) m.willson@mwcommunications.org.uk
Mark Corbett, Clinical Trial Service Unit;
T) 44-0-1865-404805;
E)mark.corbett@ctsu.ox.ac.uk
Dr Lars Lindholm, Department of Epidemiology
Umea University, SE 901 85 Umea Sweden;
T) 46-0-90-785-29-34;
F) 46-0-90-13-89-77;
E) Lars.Lindholm@epiph.umu.se
Journal
The Lancet