Authors: Rupendra Kumar Bharti*, Pratima Kosawara, P S Negi, P K Kaundal
Background: We aimed to compare lipid lowering efficacy and safety of fixed dose combination (FDC) of rosuvastatin and fenofibrate with high dose rosuvastatin (HDR) in patients of stable coronary artery disease (CAD) with mixed dyslipidemia. Materials and Methods: 165 patients with stable CAD with mixed dyslipidaemia were randomly assigned to HDR group, 40mg per day (n=79) and FDC group; fenofibrate with rosuvastatin, 145 mg and 20 mg per day respectively (n=88). The lipid profile was measured at baseline and at 12 weeks. The safety profile was measured by recording self-reported adverse reactions during follow up visits and by measuring serum levels of transaminases, creatinine phosphokinase (CPK) at 4 weeks. The lipid lowering efficacy was compared by estimating differences in percentage mean change from baseline values of the lipid fractions and percentage of patients achieving target goals between study groups using unpaired t test and Xtest respectively. Result : The FDC achieved greater reduction compared to HDR in LDL-C, -11.0% 95% C.I. (-17.7% to -4.3%) p Conclusion : The combination of moderate dose rosuvastatin and fenofibrate is more effective in reducing atherogenic lipid fractions and increasing the HDL-C level compared to high dose rosuvastatin and had better safety profile. Keywords: Mixed dyslipidemia, Rosuvastatin, Fenofibrate, Combination, Randomization
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