NPC Archive Item: ASPEN study: atorvastatin ineffective in reducing CVD outcomes in type 2 diabetes

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.
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You may have missed the results of the ASPEN study when it was published last year, as it did not seem to hit the headlines. Could it have something to do with the fact that it was a negative study?

What does this study claim?
In ASPEN, 2410 people were included with type 2 diabetes and LDL-cholesterol levels below contemporary US guideline treatment thresholds (previous CHD: LDL-cholesterol ≤ 3.6 mmol/l, no previous CHD: ≤ 4.1 mmol/l) were randomised to receive either atorvastatin 10mg /day or placebo. Over a four-year period there was a significant (approximately 30%) reduction in LDL-cholesterol in those randomised to receive atorvastatin compared with placebo. However, this did not translate into a significant reduction in serious cardiovascular (CV) events, including myocardial infarction (MI), stroke and CV death (atorvastatin 13.7%, placebo 15.0%, hazard ratio 0.90 [95% CI 0.73–1.12]). There were no statistically significant differences found between subgroups of patients with and without a history of MI or interventional procedures. Of particular note was that only around 12% of those included in the study currently smoked, compared with between 20-30% in similar studies such as ASCOT and the Heart Protection Study (HPS), not to mention the current adult UK population.

So What?
This study questions the benefit of offering atorvastatin 10mg/day routinely to all people with type 2 diabetes regardless of their other CV risk factors such as cholesterol level and smoking status. Of course, this is only one study and perhaps illustrates the fallacy of changing practice on one negative study when we have other studies such as ASCOT (with the same dose of atorvastatin) and the HPS (using simvastatin 40mg/day) that show benefits in the same patient group. This perhaps adds support to the use of simvastatin 40mg/day as the statin of choice in those who choose to take a statin.

It is worth remembering that the likely incremental benefit to individual patients with diabetes of any statin therapy needs to be considered in the context of other important interventions for reducing CV risk, such as smoking cessation, diet and exercise, blood pressure lowering, antiplatelet therapy and lowering blood glucose.

NPC has a wealth of information and educational support materials on lipid-lowering therapies as well as the management of type 2 diabetes – just click the links or even better, go to the lift and visit the relevant floors.