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Clinical question: Is apixaban non-inferior to standard therapy for treating acute VTE?
Background: Apixaban, a direct Xa inhibitor, has not been tested for efficacy and safety in treating acute VTE. Rivaroxaban, another direct Xa inhibitor, is already FDA-approved for acute VTE treatment.
Study design: Randomized, double-blinded trial.
Setting: International multi-center.
Synopsis: Researchers randomized 5400 patients with acute VTE to receive either apixaban (10 mg po bid x 7 days, then 5 mg po bid x 6 months) + placebo, or lovenox with transition to coumadin, with a goal of international normalized ratio 2-3. Recurrent VTE occurred in 2.3% of the apixaban group, compared with 2.7% in the conventional therapy group (apixaban noninferior). Major bleeding occurred less in the apixaban group than in the conventional therapy group (0.6% compared to 1.8%), as did clinically relevant non-major bleeding (3.8% compared to 8%).
Bottom line: Apixaban is a safe alternative for treating acute VTE (pending FDA approval).
Citation: Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. New Engl J Med. 2013;369:799-808.
Clinical question: Is apixaban non-inferior to standard therapy for treating acute VTE?
Background: Apixaban, a direct Xa inhibitor, has not been tested for efficacy and safety in treating acute VTE. Rivaroxaban, another direct Xa inhibitor, is already FDA-approved for acute VTE treatment.
Study design: Randomized, double-blinded trial.
Setting: International multi-center.
Synopsis: Researchers randomized 5400 patients with acute VTE to receive either apixaban (10 mg po bid x 7 days, then 5 mg po bid x 6 months) + placebo, or lovenox with transition to coumadin, with a goal of international normalized ratio 2-3. Recurrent VTE occurred in 2.3% of the apixaban group, compared with 2.7% in the conventional therapy group (apixaban noninferior). Major bleeding occurred less in the apixaban group than in the conventional therapy group (0.6% compared to 1.8%), as did clinically relevant non-major bleeding (3.8% compared to 8%).
Bottom line: Apixaban is a safe alternative for treating acute VTE (pending FDA approval).
Citation: Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. New Engl J Med. 2013;369:799-808.
Clinical question: Is apixaban non-inferior to standard therapy for treating acute VTE?
Background: Apixaban, a direct Xa inhibitor, has not been tested for efficacy and safety in treating acute VTE. Rivaroxaban, another direct Xa inhibitor, is already FDA-approved for acute VTE treatment.
Study design: Randomized, double-blinded trial.
Setting: International multi-center.
Synopsis: Researchers randomized 5400 patients with acute VTE to receive either apixaban (10 mg po bid x 7 days, then 5 mg po bid x 6 months) + placebo, or lovenox with transition to coumadin, with a goal of international normalized ratio 2-3. Recurrent VTE occurred in 2.3% of the apixaban group, compared with 2.7% in the conventional therapy group (apixaban noninferior). Major bleeding occurred less in the apixaban group than in the conventional therapy group (0.6% compared to 1.8%), as did clinically relevant non-major bleeding (3.8% compared to 8%).
Bottom line: Apixaban is a safe alternative for treating acute VTE (pending FDA approval).
Citation: Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. New Engl J Med. 2013;369:799-808.