Abstract

Background: A large number of studies have suggested that the triglyceride/high density lipoprotein cholesterol (TG/HDL-C)) ratio provides useful information about atherogenicity of plasma (AIP) and that a higher ratio has been linked to increased incidence of myocardial infarction. Others have suggested the use of AIP (log ratio of molar concentrations of TG to HDL-C) as a significant predictor of cardiovascular risk and to identify insulin resistant individuals at high cardio-metabolic risk. In this report, we analyzed data from the VASCAZEN-REVEAL trial to investigate if the correction of Omega-3 fatty acid deficiency with a unique Omega-3 formulation (referred to as 6:1 OM-3) in 6:1 ratio of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids affects TG/HDL-C and AIP indices in hypertriglyceridemic subjects. Methods: A double blind, placebo-controlled study of 42 ambulatory cardiovascular subjects with elevated baseline TG levels (200-500mg/dL) were treated with either placebo (corn oil, 4g/day, n=22) or with 6:1 OM-3 (4g/day; n=20) for 8 weeks. Primary endpoint: Correction of OM-3 deficiency by determining changes in the Omega Score (OS, constituting blood concentration of EPA, DHA and DPA-docosapentaenoic acids). Secondary endpoints: changes in the serum lipid profile including TG and HDL-C. Results: Eight weeks of treatment with 6:1 OM-3 resulted in a significant increase in placebo adjusted median OS (+120.8%, p<0.0001) with concomitant reduction in TG/HDL (-50.3%, p=0.0005), AIP (-46.9%, p< 0.0006) and in AA (arachidonic acid): EPA (-86.6%, p<0.0001) ratios. No significant changes in OS (-2.0% p= 0.5519), TG/HDL (+4.72%, p=0.5233), AIP (+2.43%, p=0.8119) or in AA/EPA (11.3%, p=0.6780) ratios were observed in placebo. Treatment with 6:1 OM-3 also resulted in a significant increase in placebo adjusted median levels of HDL-C (+9.1%, p=0.0069), a significant decrease in VLDL-C (-30.2%, p=0.0023) and with no significant changes in LDL-C (+11.3, p=0.1164). Conclusions: This study shows that 6:1 OM-3 is effective in correcting OM-3 deficiency in hypertriglyceridemic patients and that this correction is strongly associated with significant decreases in TG/HDL ratio and in AIP- an emerging predictor of cardiovascular risk.

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