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1. Omega(w)-fatty acids + macular xanthophylls supplementation did not improve primary composite outcome of cardiovascular (CV) mortality and morbidity.
Evidence Rating Level: 2 (Good)
Study Rundown: Several trials have investigated the effects of w-fatty acids on cardiovascular (CV) outcomes. More recent trials seem to point towards a lack of benefit on CV mortality. This study is a randomized clinical trial designed to examine the impact of w-fatty acids and macular xanthophylls on progression to advanced age-related macular degeneration. As part of the trial, an ancillary study called the Cardiovascular Outcome Study (COS) was created with a factorial-designed randomized trial to evaluate the impact of w- fatty acids and macular xanthophylls on a primary composite outcome of myocardial infarction (MI), stroke, and cardiovascular death. The investigators found no significant improvement in the primary or secondary outcomes with the use of w-fatty acids or macular xanthophylls. The strengths of the study include the randomized placebo controlled design, high follow-up rates, and the use of rigorous adjudication. However, readers should be aware that the study is primarily powered to detect a change in macular degeneration. Therefore, the sample size would have been inadequate to detect significant differences in singular outcomes such as rates of myocardial infarction. Therefore, a broader composite primary outcome had to be used.
Click to read the study, published today in JAMA Internal Medicine
Relevant Reading: n–3 Fatty Acids and Cardiovascular Outcomes in Patients with Dysglycemia
In-Depth [randomized controlled trial]: This study is an ancillary study (COS) of the Age-Related Eye Disease Study 2 (AREDS2). Patients who met the criteria for the AREDS2 study but also had stable coronary artery disease were eligible to participate. A total of 4203 patients were recruited at 82 centers. They were randomized to one of four primary arms: placebo, Lutein + Zeaxanthin (Macular xanthophylls), DHA + EPA (w- fatty acids), or w- fatty acids + Macular Xanthophylls. The median length of follow-up was 4.8 years. There was no significant decrease in the primary outcome in either the w-fatty acid group (HR, 0.95; 95% CI, 0.78-1.17), the macular xanthophylls group (HR, 0.94; 95% CI, 0.77-1.15), or the combined w- fatty acids + macular xanthophylls group (HR, 089; 95% CI, 0.67-1.19). The same was true for composite secondary end points as well.
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