News from ACC 2009: Benefits of combination fenofibric acid/rosuvastatin in mixed dyslipidemia

29 March, 2009 - Combination therapy with fenofibric acid and rosuvastatin calcium (135 mg/5 mg) provided significantly improved, comprehensive lipid management over either monotherapy in patients with mixed dyslipidemia. Notably, high density lipoprotein (HDL) cholesterol levels were doubled compared with rosuvastatin alone. The study was reported at the American College of Cardiology Annual Scientific Sessions, Orlando, March 29-31 2009.

Roth EM, Rosenson RS, Carlson DM et al. A phase III study evaluating the efficacy and safety of 135 mg fenofibric acid (ABT-335) in combination with 5 mg rosuvastatin in patients with atherogenic dyslipidemia. Abstract number 1021-85

This multicenter, randomized, double-blind, parallel group study included 760 patients with mixed dyslipidemia, characterised by low density lipoprotein (LDL) cholesterol ³130 mg/dL, triglycerides ³150 mg/dL and low HDL cholesterol (<40 mg/dL for men and <50 mg/dL for women). Following a 6-week run-in period in which patients were not allowed to take cholesterol modifying medications, patients were randomized to treatment with fenofibric acid monotherapy (135 mg/day), rosuvastatin monotherapy (5 mg/day) or the combination. The primary efficacy comparisons were the mean percent changes in triglycerides and HDL cholesterol with the combination versus rosuvastatin monotherapy and mean percent change in LDL cholesterol with the combination versus fenofibric acid monotherapy.

After 12 weeks, patients in the combination therapy group had significant improvements compared with rosuvastatin monotherapy in HDL cholesterol (increase by 23% vs. 12.4%) and triglycerides (decrease by 40.3% vs. 17.5%), and LDL cholesterol compared to fenofibric acid monotherapy (decrease by 28.7% vs. 4.1%). These differences were statistically significant (p<0.001). The adverse event profile of the combination therapy did not differ from those reported for the individual agents.

The combination therapy also lowered levels of C-reactive protein by 28% percent, compared with 8.7% with fenofibric acid and 11.4% with rosuvastatin monotherapy.

According to Eli Roth MD, University of Cincinnati College of Medicine, and Sterling Research Group, Cincinnati, Ohio: "More comprehensive treatment is often needed in certain patients with mixed dyslipidemia to help reach targets for all three key lipids. The results from this study are encouraging because fenofibric acid combined with the lowest available dose of rosuvastatin improved LDL cholesterol, HDL cholesterol and triglycerides."