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Table 3 Summary of phase III studies of direct oral anticoagulants for long-term prevention of recurrent VTE[4, 10, 11]

From: Pharmacokinetic and pharmacodynamic evaluation of rivaroxaban: considerations for the treatment of venous thromboembolism

Drug Study Indication Regimen Dose schedule Comparator Efficacy Safety
Rivaroxaban EINSTEIN EXT Patients with previous VTE already treated for 6–12 months with anticoagulant therapy Single drug 20 mg od for a further 6 or 12 months Placebo Recurrent VTE: rivaroxaban superior to placebo (1.3% vs. 7.1%; HR = 0.18; p < 0.001) Clinically relevant bleeding: greater incidence with rivaroxaban than placebo (6.0% vs. 1.2%; HR = 5.19; p < 0.001)
Major bleeding: similar incidence (0.7% vs. 0%; HR N/A; p = 0.11)
Apixaban AMPLIFY-EXT Patients with previous VTE already treated for 6–12 months with anticoagulant therapy Single drug 2.5 mg or 5 mg bid for a further 12 months Placebo Recurrent VTE: apixaban superior to placebo (3.8% and 4.2% vs. 11.6%; RR = 0.33 and 0.36; p < 0.001 for both doses) Clinically relevant bleeding: similar incidence (3.2% and 4.3% vs. 2.7%; RR = 1.20 and RR = 1.62; p = N/S)
Major bleeding: similar incidence (0.2% and 0.1% vs. 0.5%; RR = 0.49 and RR = 0.25; p = N/S)
Dabigatran RE-SONATE Patients with previous VTE already treated for at least 3 months with anticoagulant therapy Single drug 150 mg bid for a further 6 months Placebo Recurrent VTE: dabigatran superior to placebo (0.4% vs. 5.6%; HR = 0.08; p < 0.001) Clinically relevant bleeding: greater incidence with dabigatran than placebo (5.3% vs. 1.8%; HR = 2.92; p = 0.001)
Major bleeding: similar incidence (0.3% vs. 0%; HR N/A; p = 1.0)
Dabigatran RE-MEDY Patients with previous VTE already treated for at least 3 months with anticoagulant therapy Single drug 150 mg bid for a further 6 months Warfarin (INR 2.0–3.0) Recurrent VTE: dabigatran non-inferior to warfarin (1.8% vs. 1.3%; HR = 1.44; p = 0.01 for non-inferiority) Clinically relevant bleeding: significantly lower incidence with dabigatran vs. warfarin (5.6% vs. 10.2%; HR = 0.54; p < 0.001)
        Major bleeding: lower incidence with dabigatran but not statistically significant (0.9% vs. 1.8%; HR = 0.52; p = 0.06)
  1. bid, twice daily; HR, hazard ratio; INR, international normalised ratio; N/A, not applicable; N/S, not specified; od, once daily; RR, relative risk; VTE, venous thromboembolism.