January 1, 2011Circulation Journal115 citationsOpen Access
Efficacy and Safety of Dabigatran vs. Warfarin in Patients With Atrial Fibrillation - Sub-Analysis in Japanese Population in RE-LY Trial -
Key Result
Dabigatran 150 mg and 110 mg twice daily yielded yearly stroke or systemic embolism rates of 0.67% and 1.38% respectively, compared to 2.65% with warfarin in Japanese atrial fibrillation patients.
Study Design
Type
RCT (n=326)
Blinding
PROBE (Prospective, Randomized, Open, Blinded-Endpoint)
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does dabigatran reduce stroke and systemic embolism in Japanese patients with atrial fibrillation at high risk of stroke compared to warfarin?
P
Population
326 Japanese patients with atrial fibrillation (AF) at high risk of stroke
I
Intervention
Dabigatran 110 mg or 150 mg twice daily, administered in a blinded manner
C
Comparator
Open-label warfarin
O
Outcome
Stroke and systemic embolismcomposite
In Japanese patients with atrial fibrillation, dabigatran showed similar efficacy and safety profiles to the overall RE-LY trial population compared to warfarin.
Main Result
Effect estimate: RR 0.25
Absolute Event Rate: 0.67% vs 2.65%
Limitations
- Modest sample size of Japanese patients leading to a limited number of events and wide confidence intervals
- Minor bleeding events were reported by investigators but not adjudicated
Abstract
BACKGROUND: RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) is an international multicenter study (18,113 patients from 967 centers in 44 countries) that demonstrated the ability of dabigatran to reduce the occurrence of both stroke and hemorrhage in patients who had atrial fibrillation (AF) with high risks of stroke compared with patients who received warfarin. From Japan, 326 patients were randomized in RE-LY. METHODS AND RESULTS: RE-LY was designed to compare 2 fixed doses (110 mg or 150 mg, twice daily) of dabigatran, each administered in a blinded manner, with open-label use of warfarin. There were no major differences in patient demographic information among the overall study population and Japanese patients. However, in Japanese patients, the proportion of prior stroke was higher but prior myocardial infarction was lower than in the overall. The yearly rate for the primary endpoints (stroke and systemic embolism) was 1.38, 0.67 and 2.65%/year for 110 mg and 150 mg dabigatran twice daily and warfarin, respectively. These results were similar to the overall results (1.54, 1.11 and 1.71%/year for each group, respectively). For any bleeding, the relative risk of dabigatran at 110 mg and 150 mg twice daily over warfarin was 0.79 and 1.06, respectively, which was similar to the findings overall (dabigatran 110 mg twice daily: 0.78; 150 mg twice daily: 0.91). CONCLUSIONS: In RE-LY, the efficacy and safety profiles of dabigatran for Japanese AF patients at high risk of stroke were essentially the same as for the study population overall.