Primary Prevention With Marine Omega-3 Fatty Acids Did Not Modify MACE Risk
Supplementation with omega-3 fatty acids did not result in a lower MACE incidence compared with placebo.
|The following article is part of conference coverage from the 2018 AHA Scientific Sessions in Chicago, Illinois.The Cardiology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in cardiology. Check back for the latest news from AHA 2018.|
CHICAGO — Supplementation with marine omega-3 fatty acids was not associated with a reduced likelihood of major cardiovascular events (MACEs) or invasive cancer when compared with placebo, according to research presented at the AHA Scientific Sessions 2018, held in Chicago, Illinois, November 10-12, 2018, and simultaneously published in the New England Journal of Medicine.
Male and female study participants, 50 and 55 years of age or older, respectively, were randomized to receive (1) daily vitamin D and omega-3, (2) daily vitamin D and omega-3 placebo, (3) daily vitamin D placebo and omega-3, or (4) daily vitamin D placebo and omega-3 placebo in VITAL (Vitamin D and Omega-3 Trial) (ClinicalTrials.gov Identifier: NCT01169259).
A total of 25,871 participants were randomized to receive either eicosapentaenoic acid with docosahexaenoic acid (n=12,933) or placebo (n=12,938).
Researchers used questionnaires to collect clinical and lifestyle risk factor data at baseline. Additionally, a dietary questionnaire was used to collect data on omega-3 fatty acid consumption in the cohort.
Major cardiovascular events, including myocardial infarction (MI), stroke, or death from cardiovascular causes, and invasive cancer comprised the primary endpoints. Additionally, individual components of the composite cardiovascular endpoint, the composite endpoint in addition to coronary revascularization, site-specific cancers, and cancer-related mortality were included as secondary endpoints.
Fewer patients in the omega-3 supplementation group experienced a major cardiovascular event during a median 5.3-year follow-up compared with the placebo group (n=386 vs n=419, respectively; hazard ratio [HR], 0.92; 95% CI, 0.80-1.06; P =.24), but the difference was not significant.
No difference was observed between the omega-3 and placebo groups in terms of the incidence of invasive cancer (n=820 vs n=797, respectively; HR, 1.03; 95% CI, 0.93-1.13; P =.56).
In regard to secondary endpoints, no significant difference was found between the 2 groups in the expanded composite of cardiovascular events (HR, 0.93; 95% CI, 0.82-1.04), total MI (HR, 0.72; 95% CI, 0.59-0.90), total stroke (HR, 1.04; 95% CI, 0.83-1.31), death from cardiovascular causes (HR, 0.96; 95% CI, 0.76-1.21), and cancer-related mortality (HR, 0.97; 95% CI, 0.79-1.20).
The researchers found omega-3 supplementation to be relatively safe and associated with no serious adverse events or excess risks for bleeding.
According to the investigators, the single dose level of the omega-3 supplementation did not permit an assessment of dose-response relationships, which may limit the findings.
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Manson JE, Cook NR, Lee I, et al. Marine n−3 fatty acids and prevention of cardiovascular disease and cancer [published online November 10, 2018]. NEJM. doi: 10.1056/NEJMoa1811403