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    Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT

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    Author
    Gaba, Prakriti
    Bhatt, Deepak L
    Giugliano, Robert P
    Steg, Ph Gabriel
    Miller, Michael
    Brinton, Eliot A
    Jacobson, Terry A
    Ketchum, Steven B
    Juliano, Rebecca A
    Jiao, Lixia
    Doyle, Ralph T
    Granowitz, Craig
    Tardif, Jean-Claude
    Ballantyne, Christie M
    Pinto, Duane S
    Budoff, Matthew J
    Gibson, C Michael
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    Date
    2021-10-04
    Journal
    Journal of the American College of Cardiology
    Publisher
    Elsevier Inc.
    Type
    Article
    
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    See at
    https://doi.org/10.1016/j.jacc.2021.08.009
    Abstract
    Background: REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) randomized statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in adjudicated events, including the primary endpoint (cardiovascular [CV] death, myocardial infarction [MI], stroke, coronary revascularization, unstable angina requiring hospitalization) and key secondary endpoint (CV death, MI, stroke) with IPE. Objectives: The purpose of this study was to determine the effects of IPE on investigator-reported events. Methods: Potential endpoints were collected by blinded site investigators and subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a prespecified charter. Investigator-reported events were compared with adjudicated events for concordance. Results: There was a high degree of concordance between investigator-reported and adjudicated endpoints. The simple Kappa statistic between CEC-adjudicated vs site-reported events for the primary endpoint was 0.89 and for the key secondary endpoint was 0.90. Based on investigator-reported events in 8,179 randomized patients, IPE significantly reduced the rate of the primary endpoint (19.1% vs 24.6%; HR: 0.74 [95% CI: 0.67-0.81]; P < 0.0001) and the key secondary endpoint (10.5% vs 13.6%; HR: 0.75 [95% CI: 0.66-0.85]; P < 0.0001). Among adjudicated events, IPE similarly reduced the rate of the primary and key secondary endpoints. Conclusions: IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA - Intervention Trial]; NCT01492361).
    Rights/Terms
    Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
    Keyword
    central adjudication
    clinical trials
    icosapent ethyl
    investigator-reported endpoints
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/16850
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.jacc.2021.08.009
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