Abbott's investigational TriLipix combined with AstraZeneca's Crestor led to greater improvements than the corresponding monotherapy in treating all three key lipids—LDL cholesterol, HDL cholesterol and triglycerides, according to Phase III study results presented at the National Lipid Association’s 2008 scientific sessions in Seattle.
The randomized, double-blind, controlled, 12-week study of 1, 445 patients is part of a clinical program designed to evaluate the efficacy and safety of a fibrate in combination with statins, according to both companies.
The investigators reported that study data showed that TriLipix (ABT-335) in combination with Crestor (rosuvastatin calcium) met its primary endpoints with significantly greater improvements in HDL and triglycerides compared to rosuvastatin alone, and significantly greater improvements in LDL compared to TriLipix alone, according to the presenters. Both the combinations and rosuvastatin alone resulted in clinically meaningful reductions in LDL.
In the clinical trial, TriLipix in combination with rosuvastatin was generally well tolerated, with reported safety similar to the monotherapies, the Abbott Park, Ill.-based Abbott and the London-based AstraZeneca reported. The researchers did not identify any cases of rhabdomyolysis or unexpected liver, kidney or muscle safety issues in the study.
“Patients with mixed dyslipidemia may need treatment options that help address these three key lipids," said lead investigator Peter H. Jones, MD, Methodist DeBakey Heart and Vascular Center in Houston. “Results from this study showed that TriLipix in combination with rosuvastatin significantly increased HDL, and decreased both LDL and triglycerides.”