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Proven Efficacy Profile in DVT, PE, and Risk Reduction

XARELTO® was evaluated as a single, oral agent in three phase 3 clinical trials including more than 10,500 patients. XARELTO® showed proven efficacy for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce risk of recurrence of DVT and PE. Efficacy was also shown in a pooled subgroup analysis of DVT and PE patients.1

EINSTEIN CHOICE: 10-mg Efficacy profile

Patient Population Studied in the EINSTEIN–DVT and EINSTEIN–PE Clinical Trials

Chart showing results of the Xarelto Einstein DVT and PE trial

At least as effective as standard of care (enoxaparin + warfarin) in DVT

Xarelto is proven noninferior for treatment of DVT. Chart shows time to first occurrence of the composite of recurrent DVT or non-fatal or fatal pulmonary embolism Xarelto is proven noninferior for treatment of DVT. Chart shows time to first occurrence of the composite of recurrent DVT or non-fatal or fatal pulmonary embolism
  • Patients were randomized on either XARELTO® alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) or enoxaparin 1 mg/kg twice daily for at least 5 days with a vitamin K antagonist (VKA) and then continued with VKA only after target INR (2.0-3.0) was reached.

  • The efficacy of XARELTO® was generally consistent across major subgroups (age, weight, gender, CrCl, intended treatment duration)2,6

  • Patients with DVT were treated for 3, 6, or 12 months at physicians' discretion2

    • The mean duration of treatment was approximately 6 months1

The mean duration of treatment was 194 days for patients treated with XARELTO® and 188 days for patients treated with enoxaparin/warfarin.1

At least as effective as standard of care (enoxaparin + warfarin) in PE

Chart shows Xarelto is proven non-inferior for treatment of PE. Time to first occurrence of the composite of recurrent DVT or total PE Chart shows Xarelto is proven non-inferior for treatment of PE. Time to first occurrence of the composite of recurrent DVT or total PE
  • Patients were randomized on either XARELTO® alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) or enoxaparin 1 mg/kg twice daily for at least 5 days with a vitamin K antagonist (VKA) and then continued with VKA only after target INR (2.0-3.0) was reached

  • The efficacy of XARELTO® was generally consistent across major subgroups (age, weight, gender, CrCl, intended treatment duration)3,7

  • Patients with PE were treated for 3, 6, or 12 months at physicians' discretion3

  • The mean duration of treatment was approximately 7 months||

||The mean duration of treatment was 216 days for patients treated with XARELTO® and 214 days for patients treated with enoxaparin/warfarin.1

Pooled subgroup analysis of the EINSTEIN–DVT and –PE randomized trials

XARELTO® shown to be noninferior in regard to recurrent VTE (primary efficacy outcome), in a pooled subanalysis of all patients and patients with cancer, a previous DVT/PE, and those designated as fragile XARELTO® shown to be noninferior in regard to recurrent VTE (primary efficacy outcome), in a pooled subanalysis of all patients and patients with cancer, a previous DVT/PE, and those designated as fragile

A pooled analysis of the efficacy data of both trials was conducted, including key prespecified subgroups, such as fragile patients, those with cancer, and those with previous VTE. Both studies used identical designs, treatment regimens, outcome definitions, and adjudication processes to facilitate pooled analyses.1,4

Fragility was defined as one or more of these criteria: age >75 years, CrCl <50 mL/min, or body weight ≤50 kg.1

Extended treatment proven to reduce risk of recurrence

Does the risk persist?

Rate of recurrent DVT and PE in provoked patients was up to 5% in 1 year trial and 15% for 5 years. In unprovoked patients 1 year was up 10% and 5 years was up 30%. Rate of recurrent DVT and PE in provoked patients was up to 5% in 1 year trial and 15% for 5 years. In unprovoked patients 1 year was up 10% and 5 years was up 30%.
Nearly 1 in 3 patients with unprovoked VTE have a recurrence within 5 years of stopping anticoagulation therapy.8

VTE risk continues after treatment concludes.**

CrCl = creatinine clearance.

 

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/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.
  • 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.

References:

  1. Prins MH, Lensing AWA, Bauersachs R, et al, on behalf of the EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21.
  2. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
  3. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297.
  4. Prins MH, Lensing AWA, Brighton TA, et al. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomized controlled trials. Lancet Haematol. 2014;1(1):e37-e46.
  5. Data on file. Janssen Pharmaceuticals, Inc.
  6. Online supplement to: The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1007903/suppl_file/nejmoa1007903_appendix.pdf. Accessed October 3, 2017.
  7. Online supplement to: The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1113572/suppl_file/nejmoa1113572_appendix.pdf. Accessed October 3, 2017.
  8. Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e419S-e494S.