Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of asian patients with atrial fibrillation

So Ryoung Lee, Young Soo Lee, Ji Suck Park, Myung Jin Cha, Tae Hoon Kim, Junbeom Park, Jin Kyu Park, Jung Myung Lee, Ki Woon Kang, Jaemin Shim, Jae Sun Uhm, Jun Kim, Changsoo Kim, Jin Bae Kim, Hyung Wook Park, Boyoung Joung, Eue Keun Choi

    Research output: Contribution to journalArticlepeer-review

    52 Citations (Scopus)


    Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. Materials and Methods: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on-or off-label use according to Korea Food and Drug Regulations. Results: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA 2 DS 2 -VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. Conclusion: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.

    Original languageEnglish
    Pages (from-to)277-284
    Number of pages8
    JournalYonsei medical journal
    Issue number3
    Publication statusPublished - 2019 Mar

    Bibliographical note

    Publisher Copyright:
    © Yonsei University College of Medicine 2019.


    • Atrial fibrillation
    • Dose
    • Drug labeling
    • Non-vitamin K antagonist oral anticoagulant

    ASJC Scopus subject areas

    • General Medicine


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