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.
Bibliographical noteFunding Information:
This study was supported by the Korea National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology (2014R1A1A2A16055218), Korea Government (Ministry of Science, ICT and Future Planning) (NRF-2015R1C1A2A01054767), the Korean Healthcare Technology R&D project funded by the Ministry of Health and Welfare (HI15C1200), and also by the Technology Innovation Program or Industrial Strategic Technology Development Program (10052668, development of wearable self-powered energy source and low-power wireless communication system for a pacemaker) funded by the Ministry of Trade, Industry and Energy (MOTIE, Sejong, Korea).
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