Apixaban for Extended Treatment of Venous Thromboembolism

Apixaban for Extended Treatment of Venous Thromboembolism

February 21, 2013 | Giancarlo Agnelli, M.D., Harry R. Buller, M.D., Ph.D., Alexander Cohen, M.D., Madelyn Curto, D.V.M., Alexander S. Gallus, M.D., Margot Johnson, M.D., Anthony Porcari, Ph.D., Gary E. Raskob, Ph.D., and Jeffrey I. Weitz, M.D., for the AMPLIFY-EXT Investigators
Apixaban, an oral factor Xa inhibitor, was evaluated in a randomized, double-blind trial for extended treatment of venous thromboembolism (VTE). The study compared two doses (2.5 mg and 5 mg twice daily) with placebo in patients who had completed 6 to 12 months of anticoagulation therapy and had clinical equipoise regarding continuing or stopping treatment. A total of 2486 patients were randomized, with 2482 included in the analysis. The primary efficacy outcome was symptomatic recurrent VTE or death from VTE. In the placebo group, 8.8% of patients experienced this outcome, compared to 1.7% in both the 2.5 mg and 5 mg apixaban groups. The difference was statistically significant (P<0.001). Major bleeding occurred in 0.5% of the placebo group, 0.2% in the 2.5 mg group, and 0.1% in the 5 mg group. Clinically relevant nonmajor bleeding occurred in 2.3%, 3.0%, and 4.2% of the placebo, 2.5 mg, and 5 mg groups, respectively. The rate of death from any cause was 1.7% in the placebo group, compared to 0.8% and 0.5% in the apixaban groups. Apixaban at both doses reduced the risk of recurrent VTE without increasing the rate of major bleeding. The study concluded that extended anticoagulation with apixaban at either dose was effective and safe. The results suggest that apixaban could be a suitable option for extended treatment of VTE, particularly for patients with uncertain clinical equipoise regarding continuing therapy. The study was funded by Bristol-Myers Squibb and Pfizer. The findings indicate that apixaban may be a better option than warfarin for long-term VTE treatment due to its simplicity, fixed dose, and reduced bleeding risk. However, more data are needed to assess its benefit-to-risk profile in patients with specific risk factors, such as older age or renal impairment.Apixaban, an oral factor Xa inhibitor, was evaluated in a randomized, double-blind trial for extended treatment of venous thromboembolism (VTE). The study compared two doses (2.5 mg and 5 mg twice daily) with placebo in patients who had completed 6 to 12 months of anticoagulation therapy and had clinical equipoise regarding continuing or stopping treatment. A total of 2486 patients were randomized, with 2482 included in the analysis. The primary efficacy outcome was symptomatic recurrent VTE or death from VTE. In the placebo group, 8.8% of patients experienced this outcome, compared to 1.7% in both the 2.5 mg and 5 mg apixaban groups. The difference was statistically significant (P<0.001). Major bleeding occurred in 0.5% of the placebo group, 0.2% in the 2.5 mg group, and 0.1% in the 5 mg group. Clinically relevant nonmajor bleeding occurred in 2.3%, 3.0%, and 4.2% of the placebo, 2.5 mg, and 5 mg groups, respectively. The rate of death from any cause was 1.7% in the placebo group, compared to 0.8% and 0.5% in the apixaban groups. Apixaban at both doses reduced the risk of recurrent VTE without increasing the rate of major bleeding. The study concluded that extended anticoagulation with apixaban at either dose was effective and safe. The results suggest that apixaban could be a suitable option for extended treatment of VTE, particularly for patients with uncertain clinical equipoise regarding continuing therapy. The study was funded by Bristol-Myers Squibb and Pfizer. The findings indicate that apixaban may be a better option than warfarin for long-term VTE treatment due to its simplicity, fixed dose, and reduced bleeding risk. However, more data are needed to assess its benefit-to-risk profile in patients with specific risk factors, such as older age or renal impairment.
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Understanding Apixaban for extended treatment of venous thromboembolism.