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Label Adherence of Direct Oral Anticoagulants Dosing and Clinical Outcomes in Patients With Atrial Fibrillation.
- Source :
-
Journal of the American Heart Association [J Am Heart Assoc] 2020 Jun 16; Vol. 9 (12), pp. e014177. Date of Electronic Publication: 2020 Jun 04. - Publication Year :
- 2020
-
Abstract
- Background Dose adjustment of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in some patients with atrial fibrillation (AF), based on selected patient factors or concomitant medications. We assessed the frequency of label adherence of NOAC dosing among AF patients and the associations between off-label NOAC dosing and clinical outcomes. Methods and Results We evaluated 53 649 AF patients treated with an NOAC using Korean National Health Insurance Service database during the period from 2013 to 2016. NOAC doses were classified as either underdosed or overdosed, consistent with Korea Food and Drug Administration labeling. Cox proportional hazards regression was performed to investigate the effectiveness and safety outcomes including stroke or systemic embolism, major bleeding, and all-cause mortality. Overall, 16 757 NOAC-treated patients (31.2%) were underdosed, 4492 were overdosed (8.4%), and 32 400 (60.4%) were dosed appropriately according to drug labeling. Compared with patients with label adherence, those who were underdosed or overdosed were older (aged 71±8 and 75±7 years versus 70±9 years, respectively; P <0.001) and had higher CHA <subscript>2</subscript> DS <subscript>2</subscript> -VASc scores (4.6±1.7 and 5.3±1.7 versus 4.5±1.8, respectively; P <0.001). NOAC overdosing was associated with increased risk for stroke or systemic embolism (5.76 versus 4.03 events/100 patient-years, P <0.001), major bleeding (4.77 versus 2.94 events/100 patient-years, P <0.001), and all-cause mortality (5.43 versus 3.05 events/100 patient-years, P <0.001) compared with label-adherent use. Conclusions In real-world practice, a significant proportion (almost 2 in 5) of AF patients received NOAC doses inconsistent with drug labeling. NOAC overdosing is associated with worse clinical outcomes in Asian AF patients.
- Subjects :
- Administration, Oral
Aged
Aged, 80 and over
Atrial Fibrillation complications
Atrial Fibrillation mortality
Databases, Factual
Drug Overdose
Embolism etiology
Embolism mortality
Factor Xa Inhibitors adverse effects
Female
Hemorrhage chemically induced
Humans
Male
Middle Aged
Practice Patterns, Physicians'
Republic of Korea
Risk Assessment
Risk Factors
Stroke etiology
Stroke mortality
Treatment Outcome
Atrial Fibrillation drug therapy
Drug Labeling
Embolism prevention & control
Factor Xa Inhibitors administration & dosage
Off-Label Use
Stroke prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 2047-9980
- Volume :
- 9
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Journal of the American Heart Association
- Publication Type :
- Academic Journal
- Accession number :
- 32495677
- Full Text :
- https://doi.org/10.1161/JAHA.119.014177