Long-Term Efficacy of Rosuvastatin and Fenofibric Acid 20 mg/135 mg in Dyslipidemic Patients Initially Treated with Rosuvastatin and Fenofibric Acid 10 mg/135 mg

Abstract

Synopsis: The efficacy and safety of combination therapy with rosuvastatin and fenofibric acid were demonstrated in a 12-week, controlled study of patients with mixed dyslipidemia randomized to rosuvastatin 10, 20, or 40 mg; fenofibric acid 135 mg; or the combination of rosuvastatin and fenofibric acid (R/FA; 10/135 or 20/135 mg). A subsequent 52-week open-label extension study included an evaluation of the long-term efficacy and safety of R/FA 20/135 mg. Purpose: To evaluate the long-term efficacy of increasing the R/FA dose from 10/135 to 20/135 mg in patients initially treated for 12 weeks with R/FA 10/135 mg. Methods: Patients who completed the 12-week controlled study were eligible to enroll in the 52-week extension study and received R/FA 20/135 mg for up to 52 weeks. This analysis evaluated the effects of R/FA 20/135 mg on low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (HDL-C), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and high-sensitivity C-reactive protein (hs-CRP) in patients who had completed 12 weeks of treatment with R/FA 10/135 mg in the controlled study. All data were analyzed as observed. Median values were calculated at the end of 12 weeks of treatment with R/FA 10/135 mg in the controlled study and after 52 weeks of treatment with R/FA 20/135 mg in the extension study; a paired t-test was used to compare the two time points. Median percent changes relative to the end of 12 weeks of therapy with R/FA 10/135 mg were calculated at various time points during 52 weeks of treatment with R/FA 20/135 mg. Results: Of the 261 patients initially randomized to R/FA 10/135 mg, 220 completed the 12-week controlled study, and 187 continued treatment with R/FA 20/135 mg in the extension study. In these patients, transitioning from R/FA 10/135 to 20/135 mg resulted in additional reductions in LDL-C, non-HDL-C, apoB, and hs-CRP at all evaluated time points. After 52 weeks of therapy with R/FA 20/135 mg, a median decrease in LDL-C of 13.9% was observed (week 52 median of 80.0 mg/dL). In addition, a median decrease in non-HDL-C of 8.9% and apoB of 10.2% (week 52 median values of 105.0 and 76.0 mg/dL, respectively), as well as a median increase in HDL-C of 3.8% (week 52 median of 45.0 mg/dL) were observed. TG levels remained largely unchanged. The changes in LDL-C, non-HDL-C, apoB, and HDL-C after 52 weeks of R/FA 20/135 mg therapy were statistically significant (P ≤ .004 pre- vs post-R/FA 20/135 mg). Conclusions: Long-term combination therapy with R/FA 20/135 mg resulted in additional improvements in LDL-C, non-HDL-C, apoB, HDL-C, and hs-CRP in patients with mixed dyslipidemia initially treated for 12 weeks with R/FA 10/135 mg.