Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
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Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patientswith non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF populationand 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 werecategorized 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 edoxaban12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA2DS2-VASc score was 3.3±1.4. Only one-thirdof 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-labelreduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinineclearance ≤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.
Abstract
Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patientswith non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF populationand 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 werecategorized 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 edoxaban12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA2DS2-VASc score was 3.3±1.4. Only one-thirdof 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-labelreduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinineclearance ≤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.
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