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  • REDUCE-IT Original

    • REDUCE-IT

    "Icosapent Ethyl for Elevated Triglyceride Levels". The New England Journal of Medicine. Published on November 10, 2018. PMID: 30415628.

    Clinical Question


    Does treatment with icosapent ethyl reduce ischemic events in patients with elevated triglyceride levels who are receiving statin therapy?

    Bottom Line


    In patients with elevated triglyceride levels despite statin therapy, 2 g of icosapent ethyl twice daily significantly lowered the risk of ischemic events, including cardiovascular death, compared to placebo.

    Major Points




    Guidelines


    As of the knowledge cutoff date for this assistant, potential updates to guidelines reflecting the results of this trial are yet to be published.

    Design


    This was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 8,179 patients with established cardiovascular disease or diabetes and additional risk factors, elevated fasting triglyceride levels (135 to 499 mg per deciliter), and low-density lipoprotein cholesterol levels of 41 to 100 mg per deciliter. Participants were randomized to receive either 2 g of icosapent ethyl twice daily or placebo and were followed for a median of 4.9 years.

    Population


    The trial included adults aged 45 or older with established cardiovascular disease or 50 or older with diabetes plus additional risk factors. The median age was 64, and 28.8% were female.

    Interventions


    Patients received either 2 g of icosapent ethyl twice daily, totaling a daily dose of 4 g, or placebo.

    Outcomes


    - The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina.
    - The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

    Criticisms


    - The use of ezetimibe or PCSK9 inhibitors was not common during the trial period.
    - The mineral oil placebo used could potentially have affected statin absorption, which may have influenced the trial outcomes.

    Funding


    The trial was funded by Amarin Pharma.

    Further Reading


    Additional information can be found in the full text of this article from the New England Journal of Medicine and ClinicalTrials.gov (NCT01492361).