Both TriLipix (ABT-335) studies are part of the largest clinical program to date designed to evaluate the efficacy and safety of a fibrate in combination with statins. These studies using fenofibric acid combined with atorvastatin and simvastatin met their primary endpoints.
Combination therapy significantly improved high-density lipoproteins (HDL) and triglycerides compared to statin therapy alone, and significantly improved low-density lipoprotein (LDL) compared to TriLipix alone. Both the combinations and the two statins had clinically meaningful reductions in LDL. In the clinical trials, combination therapy was generally well tolerated, with reported safety similar to the monotherapies.
Christie Ballantyne, investigator in the TriLipix studies, said: “Data from these two studies show that TriLipix in combination with atorvastatin or simvastatin improved all three key lipids, LDL, HDL and triglycerides, in patients with multiple lipid problems.”