rct
    2020
    High Quality

    Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk (STRENGTH)

    Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ

    Published in JAMA

    Methodology

    Double-blind randomized trial of 4 g/day carboxylic acid formulation of EPA/DHA vs corn oil in statin-treated high-risk patients; terminated early for futility

    Key Findings

    Primary composite endpoint occurred in 12.0% of the omega-3 group vs 12.2% of corn oil (HR 0.99, 95% CI 0.90-1.09); atrial fibrillation was more frequent with omega-3 (2.2% vs 1.3%).

    Conclusions

    High-dose mixed EPA/DHA did not reduce major adverse cardiovascular events compared with corn oil, contrasting with REDUCE-IT.

    Limitations

    Early termination for futility; comparator differences with REDUCE-IT complicate interpretation.

    Supplements Studied

    Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, resulted in no significant difference in a composite outcome of major adverse cardiovascular events.

    Outcomes Measured

    Primary composite endpoint occurred in 12.0% of the omega-3 group vs 12.2% of corn oil (HR 0.99, 95% CI 0.90-1.09); atrial fibrillation was more frequent with omega-3 (2.2% vs 1.3%).

    The addition of omega-3 carboxylic acids resulted in no significant difference in major adverse cardiovascular events.

    Related Health Concerns

    Study Details

    Year:2020
    Sample Size:13,078
    Duration:182 weeks
    Quality Score:9/10

    Disclosures

    Funding

    AstraZeneca

    This information is for educational purposes only. Always consult a healthcare professional before starting any supplement regimen.