Effects of monotherapy with high-dose rosuvastatin compared with the combination of low-dose rosuvastatin with fenofibrate or n-3 fatty acids on non-lipid serum parameters in patients with severe mixed dyslipidemia

AP. Agouridis, TD. Filippatos, MS. Kostapanos, V. Tsimihodimos, DP. Mikhailidis, AD. Tselepis, MS. Elisaf



Introduction: The present study is a post-hoc analysis of a study that investigated the effects of hypolipidemic treatment on lipid variables in patients with mixed dyslipidemia. These patients need an overall improvement of lipid profile in order to reduce their cardiovascular risk.
Aim: This study investigated the efficacy of high-dose rosuvastatin monotherapy or low-dose rosuvastatin combined with fenofibrate or ω-3 fatty acids on non-lipid metabolic parameters in patients with severe mixed dyslipidemia and increased triglyceride levels.
Methods: Study participants (n=44) had triglyceride levels >220 mg/dl and non-HDL cholesterol >160 mg/dl and were randomized to rosuvastatin 40 mg/day (n=15, R group), rosuvastatin 10 mg plus fenofibrate 200 mg/day (n=15, RF group) or rosuvastatin 10 mg plus omega-3 fatty acids 2 gr/day (n=14, RΩ group).
Results: Homeostasis model assessment (HOMA) index was significantly increased in the R (+29%, p < 0.01 compared with baseline) and RΩ groups (+7%, p < 0.05 compared with baseline), whereas a significant decrease (-42%, p < 0.05 compared with groups R and RF) was noted in the RF group. A significantly greater reduction in serum uric acid levels was observed in the RF group compared with the R and RΩ groups (p < 0.05 for both comparisons). A significant increase in serum creatinine concentration was observed in the RF group compared with R and RΩ groups (p < 0.05). Additionally, a significant decrease of gamma-glutamyl-transpeptidase and alkaline phosphatase (p < 0.05 compared with baseline) was observed in groups R and RF.
Conclusions: The combination of low-dose rosuvastatin plus fenofibrate seems to have more potent effects on HOMA index and serum uric acid levels than high doses of rosuvastatin and small doses of rosuvastatin plus omega-3 fatty acids in individuals with sever mixed dyslipidemia and increased triglycerides.

Keywords: dyslipidemia, hypertriglyceridemia, rosuvastatin, fenofibrate, omega-3 fatty acids, uric acid