Key result
Apixaban significantly reduced the composite of major and clinically relevant non-major bleeding compared to unfractionated heparin/warfarin (7.5% vs 28.2%, RR 0.27) in Japanese patients with acute venous thromboembolism.
Why the study?
Does apixaban reduce major or clinically relevant non-major bleeding compared to UFH/warfarin in Japanese patients with acute venous thromboembolism?
RCT (n=80)
Open-label
1:1
Yes
Does apixaban reduce major or clinically relevant non-major bleeding compared to UFH/warfarin in Japanese patients with acute venous thromboembolism?
Relative Risk: 0.27 (95% CI 0.08–0.88)
Absolute Event Rate: 7.5% vs 28.2%
p-value: p=0.0160
In Japanese patients with acute VTE, apixaban was well-tolerated with a lower rate of bleeding and similar efficacy compared to standard UFH/warfarin therapy.
Apixaban may be preferred for VTE in Japanese patients; confirms global AMPLIFY results in this population.
BACKGROUND: Anticoagulation is recommended as standard of care for venous thromboembolism (VTE) (pulmonary embolism [PE]/deep vein thrombosis [DVT]), for which unfractionated heparin (UFH) and warfarin are used in Japan. In the multi-regional AMPLIFY study, a fixed-dose regimen of apixaban alone was non-inferior to conventional therapy for treatment of PE/DVT and was associated with significantly fewer bleeding events. METHODS AND RESULTS: Japan phase 3 study (AMPLIFY-J), randomized, active-controlled, open-label study in Japanese subjects with acute PE/DVT, was designed based on AMPLIFY. Key objectives were to investigate safety and efficacy of apixaban in symptomatic PE/DVT subjects during 24-week treatment. UFH/warfarin was used as control treatment. Apixaban was initiated at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 23 weeks. All endpoints and imaging for thrombotic burden were assessed by an event adjudication committee. Eighty subjects were randomized, 33 subjects (41.3%) were aged <65 years. Proportion of major/clinically relevant non-major bleeding was lower in apixaban (7.5%) compared with well-controlled UFH/warfarin (28.2%; median TTR, 70.4%). [corrected]. Recurrent VTE occurred in no subjects in apixaban and in 1 subject in UFH/warfarin. Thrombotic burden results were similar in both groups. Proportions of subjects with adverse events was generally similar in both groups. CONCLUSIONS: Apixaban was well-tolerated and had a favorable safety profile. No clinically important efficacy difference compared with UFH/warfarin was observed.
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Nakamura et al. (2015) conducted an RCT in Acute venous thromboembolism (DVT or PE) (n=80). Apixaban vs. Unfractionated heparin and warfarin was evaluated on Composite of ISTH-defined major bleeding and clinically relevant non-major (CRNM) bleeding (RR 0.27, 95% CI 0.08-0.88, p=0.0160). Apixaban significantly reduced the composite of major and clinically relevant non-major bleeding compared to unfractionated heparin/warfarin (7.5% vs 28.2%, RR 0.27) in Japanese patients with acute venous thromboembolism.
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