A comparative study of efficacy and safety of pitavastatin versus atorvastatin in the patients of dyslipidemia in medicine department of a tertiary care teaching hospital.

ABSTRACT

Background: Cardiovascular diseases (CVDs) are the major cause of death globally. Dyslipidemia is one of the most significant risk factors for CVD. 3-hydroxy 3-methyl glutaryl coenzyme A reductase inhibitors (statins), which are used for the treatment of dyslipidemia, has a beneficial effect in both primary and secondary prevention of CVD. Hence, this study was done to compare the efficacy and safety of atorvastatin versus pitavastatin in patients of dyslipidemias. Methods: After obtaining ethical clearance from institution and written informed consent from patients, 100 patients included in the study were randomly allocated to any of the following two groups. (1) Group A Tablet atorvastatin 10 mg given orally once a day for 12 weeks. (2) Group B Tablet pitavastatin 2 mg given orally once a day for 12 weeks. The primary endpoint of the study was a comparative assessment of change in lipid profile (triglyceride, low-density lipoprotein [LDL], high-density lipoprotein [HDL]) from baseline and after 12 weeks. The secondary endpoint involved recording all the adverse effects during the study. Results: Analysis of the baseline and post 12 weeks lipid levels by non-parametric unpaired t-test showed a statistically significant increase in HDL-cholesterol (HDL-C) in Group B as compared to Group A (p=0.028 i.e. p<0.05). However, there was no significant difference between two groups in decreasing LDL-cholesterol (LDL-C) (p=0.615). Conclusions: In this study, pitavastatin is found to be more efficacious than atorvastatin in increasing HDL-C levels, while as efficacious as atorvastatin in decreasing LDL-C in dyslipidemic patients. Atorvastatin is better tolerated than pitavastatin.