"We are encouraged by the overall safety reported in the ACCORD Lipid study for fenofibrate," added Sun.  "The results are consistent with the safety shown in other studies and support how fibrates are used in treatment today based on guideline recommendations."

The National Cholesterol Education Program (NCEP) treatment guidelines recommend using fibrates with statins in patients with triglycerides above 200 mg/dL when the LDL goal has been met.  

The primary endpoint for ACCORD Lipid (n = 5,518) compared fenofibrate plus simvastatin to simvastatin alone on cardiovascular outcomes of heart attacks, strokes and cardiovascular death.  There was no statistical difference in the primary outcome between the two treatment groups (p = 0.32).  In a pre-specified sub-group of patients with both high triglycerides (at or above 204 mg/dL) and low HDL (at or below 34 mg/dL), there was a 31 percent lower rate of cardiovascular events in the fibrate-plus-statin arm compared to the statin-only arm (p = 0.057 for interaction).

SOURCE Abbott