Real-world evidence on off-label underdosing of direct oral anticoagulants in Asian patients with atrial…

Cohort studyFuture science OA· Dec 2026

Real-world evidence on off-label underdosing of direct oral anticoagulants in Asian patients with atrial fibrillation: prescribing patterns, determinants, and outcomes.

Pajaree Mongkhon, Tanaphorn Koonlachad, Purachai Bvornphattanasakul … Natrawee Bureekam

Venous ThromboembolismCohort studyQ3IF 2.5

One-fifth of Asian atrial fibrillation patients received off-label underdosed anticoagulants

Real-world evidence on off-label underdosing of direct oral anticoagulants in Asian patients with atrial fibrillation: prescribing patterns, determinants, and outcomes.

Pajaree Mongkhon … Natrawee Bureekam

Future science OA · Dec 2026 · Q3 in General Medicine

Background

Off-label underdosing of direct oral anticoagulants (direct oral anticoagulants) is common among Asian patients with atrial fibrillation (atrial fibrillation), partly reflecting concerns about bleeding, yet Southeast Asian data remain limited.

Purpose

This study aimed to characterize direct oral anticoagulants dosing patterns, identify predictors of off-label underdosing, and evaluate associated effectiveness and safety outcomes.

Methods

We conducted a retrospective cohort using electronic health records (electronic health records) from two tertiary hospitals in Thailand (2015-2023).

n = 553 patients

Results

underdosing was not tied to more strokes or bleeding

AHR 1.06 (95% CI 0.30 to 3.73)

CI crosses the null - not significant

More results

Rivaroxaban was most frequently underdosed.

Older age and diabetes mellitus independently predicted underdosing.

Compared to on-label dosing, underdosing was not associated with ISSE (adjusted hazard ratio [aHR] 0.48, 95% CI 0.11-2.16; p = 0.336) or bleeding (aHR 1.06, 95% CI 0.30-3.73; p = 0.924).

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Conclusion

Off-label underdosing occurred in one-fifth of patients but was not associated with significant differences in ISSE or bleeding. Larger, prospective studies in broader Asian and non-Asian populations are warranted.

Real-world evidence on off-label underdosing of direct oral anticoagulants in Asian patients with atrial fibrillation: prescribing patterns, determinants, and outcomes.

Real-world evidence on off-label underdosing of direct oral anticoagulants in Asian patients with atrial fibrillation: prescribing patterns, determinants, and outcomes.

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