Key result
Dabigatran exposure was similar between Japanese and Caucasian subjects (median AUC 1,110 vs. 924 ng·h/ml), indicating no need for dose adjustment in Japanese patients.
Why the study?
Are there clinically relevant differences in the pharmacokinetics and pharmacodynamics of oral dabigatran between Japanese and Caucasian subjects?
Meta-Analysis
Are there clinically relevant differences in the pharmacokinetics and pharmacodynamics of oral dabigatran between Japanese and Caucasian subjects?
Absolute Event Rate: 1110% vs 924%
p-value: p=not significant
The pharmacokinetics and pharmacodynamics of dabigatran are similar between Japanese and Caucasian subjects, suggesting no need for ethnic-specific dose adjustments.
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Supports standard dabigatran dosing without ethnic adjustment in Japanese patients; confirms pharmacokinetic similarity to Caucasians.
Yamamura et al. (2011) conducted a meta-analysis in Healthy volunteers and patients with non-valvular atrial fibrillation or undergoing knee or hip arthroplasty. Dabigatran etexilate vs. Caucasian subjects was evaluated on Total exposure (area under the plasma concentration-time curve [AUC]) (p=not significant). Dabigatran exposure was similar between Japanese and Caucasian subjects (median AUC 1,110 vs. 924 ng·h/ml), indicating no need for dose adjustment in Japanese patients.
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