There may be a dose-related risk for atrial fibrillation (AF) with omega-3 acid uptake, data from four randomized clinical trials suggest.
The most recent experiment to evaluate the association, the VITAL-RHYTHM study, showed that the use of low-dose omega-3 fatty acids or vitamin D supplementation did not significantly affect the risks of developing an AF event.
The lawsuit, first reported at last year’s American Heart Association meeting, was published online today in the Journal of the American Medical Association.
However, together with three other randomized clinical trials, these results suggest an effect associated with doses of omega-3 fatty acids on the risk for AF, which is accompanied by an “Editor’s Note” praising.
An nota, le JAMA Deputy editor Gregory Curfman, MD, reveals that, in the past 2 years, four randomized clinical trials have provided data on the risk of AF with omega-3 acid uptake.
In the STRENGTH and REDUCE-IT trials, both evaluating high doses (4 g / day) of omega-3 fatty acids in patients with (or at high risk for) heart disease, there was an increase statistically significantly at risk for AF in the omega-3 vs control groups in both trials.
In the recent OMEMI trial in elderly patients with myocardial infarction, a moderate dose of (1.8 g / day) of omega-3 fatty acids showed an increase in AF risk (1.84 risk ratio) but this was not significant. . And now, the VITAL-RHYTHM test shows no significant effect at a low dose (840 mg / day) of omega-3 fatty acids on the risk of developing AF in a preventative population primary school.
“Patients who choose to take omega-3 fatty acids, especially in high doses, should be informed of the risk of AF and follow up for a possible development of this common arrhythmia. could be dangerous, “Curfman concludes.
The authors of the VITAL-RHYTHM trial, led by Christine M. Albert, MD, MPH, Cedars-Sinai Medical Center, Los Angeles, California, explain that the lawsuit was filed after observational studies showed that individuals with low blood levels of omega -3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vitamin D3 were at higher risks of AF incidence, but there were data on dietary or supplemental intake of these nutrients at mixed AF risk.
“To our knowledge, this study is the first randomized, placebo-controlled trial to test the effect of any intervention on AF event and is the only trial to test other defense agents upstream for AF in a large enough population over a sufficiently long period of time to assess the plausible benefits and risks, ”they write.
The VITAL-RHYTHM study was a supportive trial rooted within the Vitamin D and Omega-3 (VITAL) test, which used a 2 x 2 factory design to assess daily elevation with 2000 IU of vitamin D3 and / or 840 mg of omega mara- 3 fatty acids (460 mg EPA and 380 mg DHA), in primary prevention of cardiovascular disease and cancer in 25,871 men and women aged 50 and older in the United States.
Results showed that, over a median of 5.3 years of treatment and follow-up, the primary role of AF event occurred in 3.6% of the study population. For the omega-3 portion of the trial, AF events occurred in 3.7% of patients taking EPA / DHA vs 3.4% of the placebo group, giving a risk ratio of 1.09, which was not significant (P. = .19).
For a vitamin D3 vs placebo comparison, results were very similar, with AF incidence events occurring in 3.7% vs 3.4% of participants, respectively, giving a risk ratio of 1.09, which was again not significant. (P. = .19). There was no evidence of interaction between the two study representatives.
“Overall, these findings do not support the use of supplemental EPA-DHA or vitamin D3 for primary AF inhibition and provide reassurance regarding the lack of significant risk of comorbid AF frequency. associated with these common medications at these doses, “the authors conclude.
Noting that the REDUCE-IT and STRENGTH tests have seen a significant increase in AF with much higher doses of omega-3 fatty acids, they add: “ the adverse effects on AF risk may be related to doses, and the higher dosages of EPA used in these other studies may account for the significant adverse effects on AF. “
The researchers say, to their knowledge, this is the only randomized trial to evaluate the effect of vitamin D3 supplementation on AF risk and results suggest the effect of null. They add that subgroup analyzes in patients with deficient vitamin D levels (<20 ng / mL) did not suggest an advantage; however, the power to find advantage in this much smaller subset of the population was limited.
They point out that, although there were no significant differences in AF incidence for either omega-3 acid or vitamin D in the overall study population, there was a higher risk for randomized treatment-related AF event. seen in selected subgroups.
For omega-3 fatty acids, the risk of AF was significantly increased in older people, and for vitamin D3, increases in AF risk were observed in younger people and participants who drank less. alcohol.
“While the risk ratios and tests for interaction were important, the P. values associated with these subgroup analyzes were not adjusted for multiple comparisons. Therefore, these conclusions should be carefully interpreted and the generation of hypotheses considered, “they warn.
The VITAL Rhythm Study was supported by a grant from the National Institute of Heart, Lung and Blood. Albert reported receiving grants from St. Jude Medical, Abbott, and Roche Diagnostics. Curfman reports that there is no relevant information.
JAMA. Published online March 16, 2021. Abstract, Editor’s note
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