The AIM-HIGH Study (
N Engl J Med 2011; 365:2255-2267) looked at patients with established cardiovascular disease already on appropriate statin therapy who had low LDL and low HDL. They were randomized to statin alone or statin plus niacin. There was no incremental clinical benefit from the addition of niacin to
statin therapy during a 36-month follow-up period, despite significant
improvements in HDL cholesterol and triglyceride levels.
The ACCORD Trial (N Engl J Med 2010; 362:1563-1574) looked at combination lipid therapy in type 2 diabetes and found no difference in cardiovascular outcomes between statin alone and statin plus fenofibrate. However, a subgroup analysis of patients with low HDL and triglycerides above 200 did show improved outcomes. Based on this subgroup, a new clinical trial is currently underway to study whether addition of fibrates to patients on optimal statin therapy (ie: LDL less than 70) with low HDL and high triglycerides reduces cardiovascular mortality.
So niacin is out, but the the utility of fibrates is yet to be determined.
Remember: just because the numbers look good doesn't mean it has any clinical significance!
