Comparative Study of Efficacy and Safety of Atorvastatin (10mg) Co-administered with Ezetimibe (10mg) Versus Atorvastatin (20mg) Monotherapy in Newly Diagnosed Patients with Dyslipidemia
Keywords:
CHD, Atorvastatin, EzetimibeAbstract
Introduction: Coronary heart disease (CHD) refers to a narrowing of the coronary arteries. It accounts for nearly 30 percent of all deaths. Guidelines from the National Cholesterol Education Program, the American Heart Association and American stroke association all support recommendations to lower LDL to at least under 100mg/dl with recommendations to lower LDL < 70mg/dl as a ‘therapeutic option’. Ezetimibe is a novel drug in a class of lipid-lowering compounds. Added to a statin, Ezetimibe further decreased LDL to a significantly greater extent. Studies have shown that Atorvastatin and Ezetimibe combination therapy achieves greater reduction in LDL levels and greater increase in HDL levels than Atorvastatin monotherapy.
Objective: To compare the efficacy and safety of Atorvastatin co- administered with Ezetimibe versus Atorvastatin alone.
Material & Methods: This was a prospective, randomized, parallel-group, open labelled study. Sample size was 50 per group. The quantitative variables will be evaluated using unpaired t-test or chi square test. The qualitative variables will be compared using Chi-square test and mean variables by T or Anova test.
Results: A total 100 patients were enrolled. 50 patients were allocated to Atorvastatin group and 50 patients to Atorvastatin and Ezetimibe group. They had received either Atorvastatin (20 mg) or combination of Atorvastatin plus Ezetimibe (10 mg + 10 mg). Administration of Ezetimibe with Atorvastatin resulted in significantly greater percentage reduction in LDL as compared to that achieved with Atorvastatin alone. Also there was greater reduction in the levels of TC, TG, VLDL in Atorvastatin plus Ezetimibe combination group as compared with Atorvastatin alone.
Conclusion: Atorvastatin co-administered with Ezetimibe offers more effective and equally tolerated option than Atorvastatin alone for the patients with newly diagnosed dyslipidemia having LDL levels of > 100 mg/dl as it significantly lowers the LDL, TG, TC and VLDL along with significant increase in HDL.
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