Efficacy and safety of a combination therapy of atorvastatin and krill oil versus atorvastatin and niacin in dyslipidemia: a randomized, open, and comparator study

摘要

Background: Atherosclerotic cardiovascular disease is a major health problem, with CAD being the leading cause of mortality. Epidemiologic data strongly associate high CAD risk to elevated total and LDL cholesterol and low levels of HDL cholesterol. Combination therapy is often required to achieve multiple lipid treatment goals, and ≥50% reduction in low-density lipoprotein. Niacin/statin combination therapy may promote the cost-effective achievement of OLVs in several at-risk patient populations. Krill oil is extracted from Antarctic krill, Euphausia superba, a zooplankton crustacean rich in phospholipids. Krill oil significantly reduces total cholesterol, LDL, and triglycerides, and increase HDL levels and has been found to be effective in the management of hyperlipidemia and long-term regulation of blood lipids. The aim of this study is to compare the Efficacy and Safety of a combination therapy of statin and krill oil versus Statin and Niacin in dyslipidemia. Methods: 30 eligible patients were randomized in a 12 week, open-label, comparative (2-arm, 1:1), prospective study into 2 arms, the first receiving atorvastatin 10mg od and krill oil 500mg bid and the second receiving atorvastatin 10mg od and niacin 375mg od. The primary endpoint of the study was a comparative assessment of change in lipid profile (LDL, TG, 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 week lipid levels by non-parametric unpaired 't' test (Mann-Whitney test) showed a statistically significant change in two of the lipid levels (i.e. LDL - p=0.0037 in favour of statin and niacin and HDL - p=0.0003 in favour of statin and niacin). However the triglyceride levels showed no significant change in the two groups (p=0.2452). Conclusions: In our study the conventional combination therapy of statin and niacin is found to be more efficacious than the newer statin and krill oil combination in lowering LDL levels and increasing HDL levels in dyslipidemic patients. A further study with a higher sample size could confirm the findings of this study.