From the 59th Scientific Sessions of the American College of Cardiology
14th March 2010
For the last two years the Residual Risk Reduction Initiative (R3i) has supported the hypothesis of residual vascular risk and its clinical importance. This is encapsulated in the position papers published by the Foundation during this time.
Now, we are delighted that the long-anticipated announcement of the results from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial confirms that, targeting non-LDL lipids in a sub-group of statin-treated diabetic patients with well-controlled low-density lipoprotein cholesterol (LDL-C), reduces cardiovascular events and is consistent with the position taken by the R3i.1
ACCORD Lipid also shows that in this sub-group analysis, pre-specified in the study protocol, this high residual risk can be substantially reduced with the addition of fenofibrate. A reduction of 31 percent in cardiovascular risk in patients with type 2 diabetes and atherogenic dyslipidemia who had reached
LDL-C goals was achieved when compared to patients taking simvastatin alone. This reduction is comparable in magnitude to those seen in landmark statin trials.
The benefit of fenofibrate was only seen in the group of patients with atherogenic dyslipidemia, and none of the primary or secondary endpoints were statistically significant in the total study population which included many patients with LDL-C at goal and without combined atherogenic dyslipidemia. There is a risk that the positive and clinically important results seen in ACCORD Lipid will be lost in the context of ACCORD being seen as a ‘negative’ study.
This puts the R3i in a unique and very important position. We have to ensure that the clinical implications of this very important study are not misinterpreted and that the millions of diabetic patients with atherogenic dyslipidemia can benefit from a further reduction in CVD morbidity and mortality. Given the magnitude of the global epidemic of type 2 diabetes – especially in developing regions – a lipid-modifying strategy that combines fenofibrate with a statin could play an important role in reducing the global burden of residual vascular risk in type 2 diabetic patients with atherogenic dyslipidemia, who represent a huge population on a global scale.
This unique evidence from ACCORD will support our existing research activities. Indeed, the REALIST study, being conducted at Harvard Medical School and over 20 well-known academic centers worldwide, becomes even more important. The REALIST will form the platform for the R3i’s activities at the European Society of Cardiology.
ACCORD-Lipid shows that residual vascular risk can be safely and effectively addressed in patients with type 2 diabetes and atherogenic dyslipidemia. It is up to all of us to ensure that this message is communicated as effectively as possible to fellow physicians across the world as soon as possible.
1. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Eng JMed 2010. DOI:10.1056/NEJMoa1001282