Abstract 447: Treatment of Omega-3 Nutritional Deficiency Improves Cardiovascular Disease Risk Factors: Results of the Randomized, Double-Blind, Placebo-Controlled VASCAZEN-REVEAL Trial

Abstract

Introduction Treatments with Omega-3 (OM3) formulations have been suggested to have cardio-protective effects. A strong association of high plasma OM3 levels has been correlated with reduced risk of sudden death and “risk quartiles” based upon OM3 levels, have been previously described. However, systematic studies describing the extent of OM3 deficiency, it’s correction by intervention, and improvement in CVD risk factors are lacking. Our study is the first to determine dietary levels of OM3 in plasma and in red blood cells using Omega-Score and Omega-3 Index diagnostics, improvement after treatment with a proprietary “>90%-pure OM3 preparation with a 6:1 EPA (eicosapentaenoic acid): DHA (docosapentaenoic acid) ratio” (6:1-OM3), and the concomitant beneficial effects on CVD risk factors in patients with high triglycerides (TG 200-500mg/dL). Hypothesis CVD patients are nutritionally deficient in OM3 fatty acids, and through treatment with 6:1-OM3, such deficiency can be corrected, improving CVD risk factors. Methods A double blind, placebo-controlled study comprised of 110 subjects randomized and stratified by baseline TG levels (A: 90-199 mg/dL, and B: 200-500mg/dL). This report includes placebo (corn oil, n=54) and 6:1-OM3 treatment (> 3g of EPA + DHA/day; n=56) groups at baseline and after 8 weeks of treatment. The primary endpoints were the change in the Omega-Score (OS) and Omega-3-Index (OI), with secondary endpoints including the change in serum TG, lipoprotein cholesterol (VLDL, LDL, HDL, ApoB, and subfractions), and hsCRP. Results 89% of screened CVD subjects (N=655) were nutritionally deficient in Omega-3. In group B subjects, a significant (p<0.0001) increase in OS (121%) and OI (112%) was observed in treated subjects with a TG reduction of 48% (p=0.0005), VLDL-C reduction of 30% (p=0.0023) and HDL-C increase of 9% (p=0.0069) without significantly affecting LDL-C, ApoB or hsCRP levels. Conclusions This study confirms that omega-3 deficiency is prevalent with CVD, and that such a deficiency can be corrected with 6:1-OM3 resulting in a concomitant and significant placebo-corrected reduction in TG and VLDL, and increase in HDL-C in patients with high TG (200-500mg/dL), without adversely affecting LDL-C.