Original Articles: 2016 Vol: 8 Issue: 1
Comparison of the efficacy and safety of atorvastatin monotherapy and atorvastatin plus fenofibrate combination therapy in combined dyslipidemia
Abstract
Dyslipidemia is a major risk factor for Coronary Artery Disease (CAD). Dyslipidemic patients display abnormal lipid profiles associated with elevated levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein cholesterol (VLDL-C), as well as reduced levels of highdensity lipoprotein cholesterol (HDL-C).The present study aims at evaluating the efficacy and safety of atorvastatin monotherapy versus atorvastatin plus fenofibrate combination therapy in dyslipidemic patients from Tiruchirappalli (Tamil Nadu, India).This is a randomized, open-label, parallel study comparing the efficacy and safety of the atorvastatin monotherapy (10 mg) (Group A) with the atorvastatin plus fenofibrate combination therapy (10/135 mg) (Group B) for 24 weeks in dyslipidemic patients(n=80) with regard to lipid profiles. Both atorvastatin monotherapy and atorvastatin plus fenofibrate combination therapy were significantly effective in reducing the levels of TC by 16.24% and 15.95% (p<0.001, both),TG by 16.57% and 34.02% (p<0.001, both), LDL-C by 24.40% and 26.11% (p<0.001, both), and VLDL-C by 17.96% and 33.50% (p<0.001, both), respectively. Interestingly, atorvastatin monotherapy did not cause a significant increase in HDL-C level (0.63%, p=0.37), which was significantly increased by 25.48% (p<0.001) after atorvastatin plus fenofibrate combination therapy. The lipid profile changes appear to be gender-dependent, in which females responded better to both treatments. Both treatments were safe and caused no serious side effects. Overall, atorvastatin plus fenofibrate combination therapy is more effective than atorvastatin monotherapy. In sum, both treatments display high efficacy and safety in the treatment of hyperlipidemia.