OPEN LABEL RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFICACY OF ATORVASTATIN ALONE AND COMBINATION OF ATORVASTATIN AND EZETIMIBE IN PRIMARY DYSLIPIDEMIA

Abstract

Introduction: Coronary artery disease (CAD) is assuming increasing importance among the developed as well as developing countries. Various studies have associated the direct casual relationship between CAD and dyslipidemia. Statins are the most widely used hypolipidemic drugs. Despite the proven efficacy of statin therapy, there is a significant gap between evidence based medicine and real world clinical practice. Objectives:The study was designed to evaluate the efficacy of atorvastatin alone and combination of atorvastatin and ezetimibe in patients diagnosed with primary dyslipidemia. Methods: An open labelled, randomized study enrolling 200 patients diagnosed with CAD and primary dyslipidemia was conducted in the Department of Cardiology M.S.Ramaiah Hospitals, Bengaluru. These patients were randomized to either atorvastatin 10 mg alone once daily or combination of atorvastatin 10mg and ezetimibe 10 mg once daily for 3 months. Lipid profile was analysed both at the entry as well as at the end of the study. Results: The reduction of LDL-C level between the atorvastatin alone and combination of atorvastatin and ezetimibe group from the baseline was 41.63 mg/dl and 49.98 mg/dl respectively (P <0.001). On comparing between the 2 groups the combination group had higher reduction than the atorvastatin alone group (P < 0.001). Conclusion: The combination of atorvastatin and ezetimibe is highly effective in treatment of primary dyslipidemia.