While it is true that the none of the primary or secondary endpoints were statistically significant in the total study population the Action to Control Cardiovascular Risk in Diabetes (ACCORD)included many patients with LDL-C at goal and without combined atherogenic dyslipidemia.
For the last two years the Residual Risk Reduction initiative (R3i) has supported the hypothesis that in patients with atherogenic dyslipidaemia there is a residual vascular risk which is clinically importance. This is encapsulated in the position papers published by the Foundation during the last two years (www.r3i.org ).
The R3i believes that although being negative for the majority of type 2 diabetics enrolled in ACCORD the results from the 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.
ACCORD Lipid 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 who had reached LDL-C goals but also have a triglycerides level of 204mg/dL (2.3 mmol/L) or higher and HDL-cholesterol of 34 mg/dL (0.88 mmol/L or lower was achieved when compared to patients taking simvastatin alone. This reduction is consistent with the conclusions of the ACCORD study investigators themselves and is comparable in magnitude to those seen in landmark statin trials.
Patients with atherogenic dyslipidaemia had 70 percent more cardiovascular events (cardiovascular deaths, heart attacks and strokes) providing evidence that residual cardiovascular risk is real.
Atherogenic dyslipidaemic patients made up 17 percent of the study population. Experts believe that this figure is likely to be much higher.
ACCORD Lipid also confirms the safety of combining fenofibrate with a statin and showed a significant effect on macro- and microalbuminuria across the whole study population.
We are conserned that 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.
ACCORD-Lipid shows that residual vascular risk can be safely and effectively addressed in patients with type 2 diabetes and atherogenic dyslipidemia. The R3i beleives that this message should be communicated as effectively as possible to fellow physicians across the world as soon as possible.