The aim of the study was to evaluate the efficacy and safety of rosuvastatin in combination with fenofibric acid in a group of patients treated for 12 weeks with rosuvastatin 10 mg + fenofibric acid 135 mg and consequently treated for up to 52 weeks with rosuvastatin 20 mg + fenofibric acid 135 mg. The patients included in the study were men and women ≥18 years of age with mixed dyslipidemia, determined as TG ≥150 mg/dL, LDL-C ≥130 mg/dL, and HDL-C <40/50 mg/dL. In the 12-week controlled study the patients were randomized to receive rosuvastatin 10, 20, or 40 mg, fenofibric acid 135 mg, or rosuvastatin 10 or 20 mg + fenofibric acid 135 mg. The patients who completed the 12 week controlled study were entitled to enroll in a subsequent 52-week open-label study and received rosuvastatin 20 mg + fenofibric acid 135 mg. The post hoc analysis assessed the patients treated with rosuvastatin 10 mg + fenofibric acid 135 mg in the controlled study and received rosuvastatin 20 mg + fenofibric acid 135 mg in the open-label study. The variables of efficacy were mean percentage changes in LDL-C, HDL-C, non- HDL-C, and apolipoprotein B (ApoB), and median percentage changes in TG and high-sensitivity C-reactive protein (hsCRP) from baseline to incremental time up to 52 weeks in the extension study, and the proportion of patients attaining individual and mutual goals for LDL-C and non-HDL-C. The results of the study revealed that:

• Out of 261 patients primarily randomized to rosuvastatin 10 mg + fenofibric acid 135 mg, 220 completed the controlled study and 187 sustained to the treatment with rosuvastatin 20 mg + fenofibric acid 135 mg in the extension study
• Raising the rosuvastatin dose from 10 mg to 20 mg in combination with fenofibric acid 135 mg for up to 52 weeks ensued in considerable mean percentage changes from baseline in LDL-C (-9.5%), non-HDL-C (-6.0%), ApoB (-8.5%), and HDL-C (3.6%), while median TG levels remained largely unchanged (0.8%) at the end of week 52
• Massive percentage of patients attained their risk-stratified lipid goals at week 52 compared with baseline for LDL-C (89% versus 84%), non-HDL-C (50% versus 25%), and both LDL-C and non-HDL-C (50% versus 19%)
• The combination therapy was well tolerated and the incidence of muscle-, hepatic-, and renal-related adverse effects and laboratory values were within the anticipated range.

The investigators therefore concluded that combination therapy with rosuvastatin and fenofibric acid was well tolerated and raising the rosuvastatin dose from 10 mg to 20 mg in the combination results in further beneficial effects on key lipid parameters in patients with mixed dyslipidemia.

Source: Ferdinand KC, Davidson MH, Kelly MT, Setze CM. One-year efficacy and safety of rosuvastatin + fenofibric acid combination therapy in patients with mixed dyslipidemia: evaluation of dose response. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):117-25.