Abstract 20243: Differential Uptake of Omega-3 Polyunsaturated Fatty Acids in Trial Subjects Could Explain Variability of the Trials’ Outcome
Background: A relationship of regular fish consumption with lowered incidence of cardiovascular disease (CVD) has been appreciated for decades. However, preparations from fish oils, showed mixed results in recent meta-analyses and have raised some doubts on the efficacy of omega-3 polyunsaturated fatty acids (ω-3 PUFA) for management of CVD. Some of these reports suffer from inclusion of studies with ill-defined patient populations, varying PUFA doses, purity, and formulation, while others have patients on drug milieu or have employed placebo that could have undermine the trial outcome. Very few studies have determined ω-3 PUFA levels pre & post treatment. In this report, we are the first to describe heterogeneity of Omega 3 uptake among trial subjects that could have contributed to the inconsistencies of results.
Methods: In VASCAZEN-REVEAL trials, 54 subjects with normal to high blood triglycerides levels (TG 90-500mg/dl) and with ω-3 PUFA deficiency (Omega-Score™, OS, blood levels of eicosapentaenoic (EPA)+docosahexaenoic (DHA) +docosapentaenoic acid (DPA) of <6.1% of total blood fatty acids) were provided 4g/day of 6:1 EPA/DHA formulation (>90% purity) for 8 weeks. Changes in the OS levels pre-and post treatment along with individual fatty acids including arachidonic (AA) were determined and desaturation enzymes activities were calculated.
Results: Based upon post-treatment increases in the blood levels of OS, weak (WR), intermediate (IR) and strong (SR) responders were identified.
Conclusion: This is the first report to show differential effect of Omega-3 on trial subjects and warrants caution in the interpretation of trial data without identifying the responders.
Author Disclosures: N.A. Shaikh: Consultant/Advisory Board; Modest; Consultant. S.N. Shaikh: None. J. Yantha: Employment; Significant; STAFF. G. Jackowski: Employment; Significant; CSO.
- © 2014 by American Heart Association, Inc.