Abstract 5069: Atorvastatin/Fenofibrate 40/100 mg Fixed-Dose Combination Tablet (LCP-AtorFen 40/100 mg) Offers Improved Efficacy Over 40 mg Atorvastatin and Higher Dose 145 mg Fenofibrate in Patients with Dyslipidemia
This was a multicenter, randomized, double-blind study comparing the efficacy and safety of a fixed-dose combination tablet of atorvastatin/fenofibrate 40/100 mg (LCP-AtorFen 40/100 mg), 40 mg atorvastatin, and 145 mg fenofibrate in men and women, ≥18 yrs, with mixed dyslipidemia (non-HDL-C >130 mg/dL; TG ≥ 150 mg/dL and ≤500 mg/dL). Washout was 4 – 8 wks depending on prior therapy (fibrate, niacin, statin, etc). Primary efficacy endpoints were the mean % changes from baseline to final visit (Week 12) in non-HDL-C, HDL-C, and TG. Secondary variables were LDL-C, Apo B, fibrinogen, Lp(a), hs-CRP and MPO. Safety endpoints included adverse events (AEs) and changes in laboratory values. Of 220 subjects randomized (safety analysis), 200 were analyzed for efficacy, and 192 completed the study. LCP-AtorFen had greater decreases in non-HDL-C, TG and Apo B, and greater increases in HDL-C, than either atorvastatin or fenofibrate alone. Cardiac risk markers showed greater increases with atorvastatin: Lp(a) (20%), MPO (37%) and fibrinogen (7%) compared to LCP-AtorFen: 10% (p=NS), 7% (p=0.057) and -1% (p<0.001), respectively. However, the 2 treatments had similar median % decreases in hs-CRP; ~ 35%. The incidence of any AEs was 58.9%, 66.2% and 65.8% for LCP-AtorFen, atorvastatin and fenofibrate; LCP-AtorFen had the fewest “related” AEs: 16.4%, 23.0% and 26.0%, respectively. There were no incidences of muscle-associated AEs with LCP-AtorFen compared to 5 and 4 total incidences in the other treatments, respectively. There were no incidences of rhabdomyolysis in any group. The fixed-dose combination tablet LCP-AtorFen 40/100 mg resulted in a greater improvement in primary lipid parameters compared to either 40 mg atorvastatin or the higher dose 145 mg fenofibrate therapy alone. LCP-AtorFen 40/100 mg also demonstrated improvement in cardiac risk markers and a trend towards better safety. A 12 month, open-label, extension study is ongoing.