LONG-TERM EFFICACY OF FENOFIBRIC ACID 135 MG IN COMBINATION WITH ROSUVASTATIN 20 MG IN PATIENTS WITH MIXED DYSLIPIDEMIA

Abstract

Background: Fenofibric acid + statin combination therapy over 12 weeks results in more comprehensive improvement in mixed dyslipidemia than the individual monotherapies. This 2-year analysis evaluated the long-term efficacy and safety of fenofibric acid + rosuvastatin in patients with mixed dyslipidemia. Methods: Patients were initially randomized to fenofibric acid, rosuvastatin, or fenofibric acid + rosuvastatin treatment for 12 weeks, which was followed by open-label treatment with fenofibric acid 135 mg + rosuvastatin 20 mg in 2 subsequent year-long extension studies (year 1 and 2). Only patients treated in the year 2 study were analyzed. Mean levels of efficacy and safety laboratory values at pretreatment baseline (week 0), week 64, and week 116, and mean percent changes from baseline to week 116 were evaluated. Data are summarized as observed. Results: Baseline lipid levels (N=174) are consistent with mixed dyslipidemia (Table). Compared with baseline, all mean lipid levels were considerably improved at week 64 and week 116. Minor mean changes from week 0 to 116 were observed in the safety laboratory values. Adverse events tended to occur early in the treatment course and no new or unexpected muscle, hepatic, or renal safety signals occurred.