Background: Dabigatran, a direct thrombin inhibitor, is commonly used for the prevention of stroke or systemic embolism in patients with atrial fibrillation (AF) and the treatment of venous thromboembolism (VTE). Either dabigatran 110 mg or 150 mg is recommended in AF patients. However, there were limited data on dabigatran levels in Asian patients using two different doses.

Aims: This study aimed to investigate the plasma levels of dabigatran 110 mg (D110) or 150 mg (D150) twice daily in Thai patients who had AF or VTE.

Methods: This was a single center, cross-sectional study. We included all adult patients (age ≥ 18 years) who were diagnosed with AF or VTE and who were prescribed either dabigatran 110 mg or 150 mg twice daily. We collected data regarding to age, sex, comorbidities, concomitant medications and coagulation tests. Peak and trough levels of dabigatran were measured by diluted thrombin time.

Results: There were 80 patients included in the study (39 in D110 and 41 in D150 group). D150 group had lower mean age (64.39 vs 75.85 years) and higher mean creatinine clearance (CrCl) (69.83 vs 47.20 ml/min). Comparing between two groups, there was no significant difference in trough and peak plasma dabigatran levels in patients with CrCl ≥ 50 ml/min (figure 1). In patients with CrCl < 50 ml/min, there was significant higher mean peak plasma dabigatran level in D150 group compared to D110 group (383.69 ng/mL vs 207.67 ng/mL, P=0.01, figure 1). Patients who had CrCl < 50 ml/min were more likely to have over expected range of dabigatran (figure 2). After adjusting for age and CrCl, D150 was associated with over expected plasma level (odds ratio, 1.12; 95% confidence interval, 1.01-1.25; P=0.037).

Trough and peak level of dabigatran in patient who received 110mg compared with 150mg of dabigatran according to creatinine clearance

Peak level of dabigatran categorized by expected range of peak plasma level for standard dose

Conclusions: In Asian patients, dabigatran 150 mg twice daily was associated with higher plasma dabigatran levels, especially in those with impaired renal function.

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/appropriate-dose-of-dabigatran-in-asian-population/