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Proven Efficacy Profile Versus Enoxaparin After Knee or Hip Replacement Surgery

The efficacy of XARELTO® in a once-daily dose was proven in three phase 3 clinical trials including more than 9000 patients. Significant reductions were achieved in total venous thromboembolism (VTE) and major VTE after hip replacement surgery, as extended therapy after hip replacement surgery, and after knee replacement surgery.

Significantly lower rates of total VTE* and major VTE after hip replacement surgery

71% relative risk reduction of total VTE with XARELTO® after hip replacement surgery 71% relative risk reduction of total VTE with XARELTO® after hip replacement surgery 91% relative risk reduction of major VTE with XARELTO® after orthopedic surgery of the hip 91% relative risk reduction of major VTE with XARELTO® after orthopedic surgery of the hip

XARELTO® delivered 71% and 91% reductions in total VTE and major VTE after hip replacement surgery, respectively, versus enoxaparin in the RECORD1 trial.

  • Results for the components of total VTE (XARELTO® vs enoxaparin): proximal DVT (0.1% vs 2.1%); distal DVT (0.8% vs 1.8%); nonfatal PE (0.2% vs 0.1%); death from any cause (0.3% vs 0.3%)

  • Symptomatic VTE (secondary analysis): 0.2% for XARELTO® versus 0.5% for enoxaparin

*Primary endpoint: total VTE was a composite of proximal and/or distal DVT, nonfatal PE, and death from any cause.

Major VTE was a composite of proximal DVT, nonfatal PE, and VTE-related death.

Significantly lower total VTE and major VTE# for extended treatment after hip replacement surgery

76% relative risk reduction of total VTE with XARELTO® for extended-duration prophylaxis after hip replacement surgery 76% relative risk reduction of total VTE with XARELTO® for extended-duration prophylaxis after hip replacement surgery 87% relative risk reduction of major VTE with XARELTO® for extended-duration prophylaxis after hip replacement surgery 87% relative risk reduction of major VTE with XARELTO® for extended-duration prophylaxis after hip replacement surgery

XARELTO® delivered 76% and 87% reductions in total VTE and major VTE for extended treatment with XARELTO® after hip replacement surgery, respectively, versus short-term enoxaparin in the RECORD2 trial.

  • Results for the components of total VTE (extended-duration XARELTO® vs short-term enoxaparin): proximal DVT (0.6% vs 4.8%); distal DVT (1.3% vs 5.2%); nonfatal PE (0.1% vs 0.5%); death from any cause (0.2% vs 0.5%)

  • Symptomatic VTE: 0.3% for XARELTO® versus 1.3% for enoxaparin

  • Comparative efficacy claims with enoxaparin may not be drawn from this study due to the differences in the treatment duration of XARELTO® and enoxaparin

Primary endpoint: total VTE was a composite of proximal and/or distal DVT, nonfatal PE, and death from any cause.

#Major VTE was a composite of proximal DVT, nonfatal PE, and VTE-related death.>

Significantly lower total VTE§§ and major VTE|||| after knee replacement surgery

48% relative risk reduction of total VTE with XARELTO® after orthopedic surgery of the knee 48% relative risk reduction of total VTE with XARELTO® after orthopedic surgery of the knee 60% relative risk reduction of major VTE with XARELTO®after knee replacement surgery 60% relative risk reduction of major VTE with XARELTO®after knee replacement surgery

XARELTO® delivered 48% and 60% reductions in total VTE and major VTE after knee replacement surgery, respectively, versus enoxaparin in the RECORD3 trial.

  • Results for the components of total VTE (XARELTO® vs enoxaparin): proximal DVT (1.1% vs 2.2%); distal DVT (9.1% vs 17.7%); nonfatal PE (0% vs 0.5%); death from any cause (0% vs 0.2%)

  • Symptomatic DVT: 0.7% for XARELTO® versus 2.0% for enoxaparin

§§Primary endpoint: total VTE was a composite of proximal and/or distal DVT, nonfatal PE, and death from any cause.

||||Major VTE was a composite of proximal DVT, nonfatal PE, and VTE-related death.

ARR = absolute risk reduction.

 

Indications

 

IMPORTANT SAFETY INFORMATION

 

Indication and Important saftey Information

 

  • Reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). There are limited data on the relative effectiveness of XARELTO® (rivaroxaban) and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.
  • Treatment of deep vein thrombosis (DVT).
  • Treatment of pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and/or PE.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery.