Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
Authors
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 Par ; Boyoung Joung ; Eue-Keun Choi
Administration, Oral ; Aged ; Anticoagulants/administration & dosage* ; Anticoagulants/therapeutic use* ; Asian Continental Ancestry Group* ; Atrial Fibrillation/complications ; Atrial Fibrillation/drug therapy* ; Dabigatran/administration & dosage ; Dabigatran/therapeutic use ; Drug Labeling* ; Female ; Humans ; Male ; Medication Adherence* ; Middle Aged ; Prospective Studies ; Pyrazoles/therapeutic use ; Pyridines/therapeutic use ; Pyridones/therapeutic use ; Republic of Korea ; Risk Factors ; Rivaroxaban/administration & dosage ; Rivaroxaban/therapeutic use ; Thiazoles/therapeutic use ; Vitamin K/antagonists & inhibitors*
Keywords
Atrial fibrillation ; dose ; drug labeling ; non-vitamin K antagonist oral anticoagulant
Abstract
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 CHA₂DS₂-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.