High Doses of Rosuvastatin are Superior to Low Doses of Rosuvastatin Plus Fenofibrate or n‐3 Fatty Acids in Mixed Dyslipidemia

Abstract

The aim of the study was to compare the efficacy of high-dose rosuvastatin, low-dose rosuvastatin plus fenofibrate and low-dose rosuvastatin plus omega-3 fatty acids with regard to the lipid profile in patients with mixed hyperlipidemia. The primary endpoint was changes in non-high density lipoprotein-cholesterol (non-HDL-C) levels. Study participants were randomly allocated to receive rosuvastatin 40 mg (n = 30, R group), rosuvastatin 10 mg plus fenofibrate 200 mg (n = 30, RF group) or rosuvastatin 10 mg plus n-3 fatty acids 2 g (n = 30, RN group). Non-HDL-C levels were reduced in all groups: in R group by 54%, in RF group by 42% and in RN group by 42%. Significant reductions in total cholesterol (TC), low density lipoprotein (LDL)-C and triglyceride levels were observed in all groups. The reductions in total and LDL-C were greatest in the R group while a more pronounced reduction of triglycerides in the RF group compared with that in the R and the RN group was observed. HDL-C levels were significantly increased only in the RF group. In conclusion, high doses of rosuvastatin and small doses of rosuvastatin plus either fenofibrate or n-3 fatty acids exhibit favorable effects on both LDL-C and non-HDL-C levels. However, rosuvastatin monotherapy more potently reduces these parameters. The combination of rosuvastatin plus fenofibrate leads to a greater decrease in triglyceride levels and a greater increase in HDL-C levels compared with the other two treatments. While awaiting the results of ongoing trials high doses of rosuvastatin may represent the treatment of choice in individuals with mixed dyslipidemia.

Effect of rosuvastatin monotherapy or in combination with fenofibrate or ω-3 fatty acids on lipoprotein subfraction profile in patients with mixed dyslipidaemia and metabolic syndrome

“…On the other hand, RF reduced TG levels more than R monotherapy and RF and was the only treatment that significantly increased HDL‐C levels. These effects on the serum lipid profile are consistent with our previous findings in the whole population consisting of patients with mixed dyslipidaemia independently of the presence of MetS (12,13). The LDL subfraction profile, expressed by sdLDL cholesterol, was improved by all treatments, but more with RF.…”

“…All regimens significantly reduced total plasma lipoprotein‐associated phospholipase A 2 (Lp‐PLA 2 ), but R and RF were more effective compared with Rω (13). The present work is a substudy that only includes patients with MetS from the previously published study (12). We assessed the effect of rosuvastatin‐based regimens on their LDL and HDL subfraction profile.…”

Effect of hypolipidemic treatment on emerging risk factors in mixed dyslipidemia: a randomized pilot trial

“…In our study, the highest dose of rosuvastatin followed by add-on ER-NA/LRPT were associated with the most pronounced apoB level reduction, followed by the add-on fenofibrate group. In addition, fenofibrate monotherapy and combined with rosuvastatin have been associated with significant apoB level reduction in patients with mixed dyslipidaemia [29,30]. In addition, fenofibrate monotherapy and combined with rosuvastatin have been associated with significant apoB level reduction in patients with mixed dyslipidaemia [29,30].…”

Adverse events following statin–fenofibrate therapy versus statin alone: A meta‐analysis of randomized controlled trials

“…Because the duration of follow up could affect the incidence of increased enzyme levels and muscle‐associated AEs, we analysed the effect of follow‐up duration (< 12 months vs > 12 months) on the incidence of AEs. In eight studies, the duration of follow up was < 12 months, whereas in five studies it was > 12 months.…”

“…Muscle‐associated AEs were defined as myalgia, musculoskeletal discomfort, muscle spasm, muscle weakness, arthralgia, musculoskeletal stiffness, musculoskeletal pain and rhabdomyolysis. All 13 studies reported muscle‐associated AEs …”