Comparative study on efficacy and safety of atorvastatin in combination with ezetimibe and atorvastatin monotherapy among patients with dyslipidemia – A randomized and double-blind study

ABSTRACT

Background: Dyslipidemia is defined as the high-density lipoprotein and apolipoprotein A (apo A) levels <10th percentile and/or total cholesterol, triglycerides, low-density lipoprotein (LDL), apolipoprotein B, or Lipoprotein (a) levels more than the 90th percentile. Aim and Objectives: This study aimed to compare the efficacy and safety of the fixed-dose combination of Atorvastatin and Ezetimibe with Atorvastatin monotherapy among patients with dyslipidemia. Materials and Methods: The present study was a randomized, double-blinded, prospective, and parallel-group study. Ninety-two outpatients of age in between 18 and 70 years from the Department of General Medicine who attended the hospital for the treatment of dyslipidemia were selected as study participants. Among 92 patients, 12 patients did not meet the study criteria. The remaining 80 patients were divided into two treatment groups at random and under double-blind conditions (39 in Group A and 41 in Group B). Each patient in both groups was followed for a period of 4 weeks after initiation of therapy. Total cholesterol and LDL-cholesterol levels were recorded at day 1, 2 weeks, and 4 weeks of therapy. Results: In this study, by the end of the study period (4 weeks), tablet Atorvastatin + tablet Ezetimibe combination therapy showed statistical significance difference in reducing mean total cholesterol and mean serum LDL levels in dyslipidemia cases than the group receiving Atorvastatin monotherapy. Conclusion: Atorvastatin in combination with Ezetimibe was more efficacious than Atorvastatin monotherapy in reducing total blood cholesterol and serum LDL levels. Atorvastatin plus Ezetimibe is equally safer as Atorvastatin monotherapy and well tolerated with fewer adverse effects.