The New England Journal of Medicine has published two subgroup analyses of the ACCORD study. The first analysis compares combination lipid lowering therapy to standard care and the second analysis compares intensive blood pressure control to standard care.
In the first analysis, 5,518 patients with type 2 diabetes were treated with open label simvastatin and randomly assigned to blinded treatment with fenofibrate or placebo. The primary outcome was a composite of non-fatal myocardial infarction, non-fatal stroke or death from cardiovascular causes. The study found no statistical differences between the two groups for the primary outcome or for any of the secondary outcome when analysed individually.
The authors conclude that, "these results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk".
In the second analysis, 4,733 participants were assigned to intensive blood pressure treatment with the aim of reaching a systolic blood pressure target of 120mmHg or less versus standard treatment with a target of 140mmHg or less. Again, the primary outcome was a composite of non-fatal myocardial infarction, non-fatal stroke or death from cardiovascular causes.
The study found no statistical difference in the primary outcome however there was a lower risk of stroke (Hazard ratio 0.59, 95% CI 0.39 - 0.89, p=0.01). It was also noted that there was a higher risk of adverse events (3.3% of participants in the intensive arm versus 1.3% in the standard arm).
The authors conclude that, "a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events".
The current NICE guideline recommends that blood pressure is treated to below 140/80mmHg (or 130/80mmHg in the presence of kidney, eye or cerebrovascular damage) and that fibrates are used in addition to statins to treat hypertriglyceridaemia (2.3 to 4.5 mmol/L) in individuals with high cardiovascular risk.
Action: Clinicians should be aware of these analyses. The results indicate that aggressive treatment to reach targets below those recommended by NICE results in no or limited benefit while increasing the risk of side effects.