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Proven Safety Profile in DVT, PE, and Risk Reduction

The safety profile of XARELTO® as a single, oral agent was proven in three phase 3 clinical trials for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for reducing the risk of recurrence of DVT and PE in more than 9400 patients. Safety data was also shown in a pooled subgroup analysis of DVT and PE patients.1,2

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

46% relative risk reduction in major bleeding versus standard of care (enoxaparin + warfarin)1

ROCKET AF studied Xarelto in patients with prior stroke or multiple comorbidities ROCKET AF studied Xarelto in patients with prior stroke or multiple comorbidities

Principal safety outcome: comparable rates of the composite of major bleeding and clinically relevant nonmajor bleeding across treatment groups1

Significantly lower (46% relative risk reduction) major bleeding with XARELTO® versus standard of care in the pooled analysis Significantly lower (46% relative risk reduction) major bleeding with XARELTO® versus standard of care in the pooled analysis
  • 9.4% (388/4130) for XARELTO® versus 10.0% (412/4116) for enoxaparin + warfarin

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

A pooled analysis of the safety data of both trials was conducted, including key prespecified subgroups, such as patients with cancer, patients with previous VTE, and fragile** patients. Both studies used identical designs, treatment regimens, outcome definitions, and adjudication processes to facilitate pooled analyses.1,2

Nonmajor clinically relevant plus major bleeding of XARELTO® versus standard of care in the pooled anaysis Nonmajor clinically relevant plus major bleeding of XARELTO® versus standard of care in the pooled anaysis Major bleeding in a pooled subanalysis of XARELTO® versus standard of care, including patients with cancer, patients with previous VTE, and fragile patients Major bleeding in a pooled subanalysis of XARELTO® versus standard of care, including patients with cancer, patients with previous VTE, and fragile patients

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

Proven safety profile when extending treatment to reduce risk of recurrence

Does the risk persist?

Proven safety during bleeding events with extended-duration XARELTO® Proven safety during bleeding events with extended-duration XARELTO®
Nearly 1 in 3 patients with unprovoked VTE have a recurrence within 5 years of stopping anticoagulation therapy.7

VTE risk continues after treatment concludes.‡‡

Continuing XARELTO® therapy beyond initial regimen with proven safety profile||||

Bleeding events of XARELTO® versus placebo in EINSTEIN-EXT safety population Bleeding events of XARELTO® versus placebo in EINSTEIN-EXT safety population

EINSTEIN–EXT, a randomized, double-blind, event-driven, superiority trial, was part of the largest DVT and PE phase 3 clinical trial program ever conducted (N=9477).¶¶

  • All patients had already undergone 6 to 14 months## of anticoagulation therapy and were at clinical equipoise with respect to the need for continued anticoagulation2

  • Patients were randomized on either XARELTO® 20 mg once daily or placebo

  • There were no fatal or critical-organ bleeding events

‡‡VTE treatment guidelines suggest ongoing treatment could begin any time after 3 months of initial treatment.6,7

||||Longer than 6 months.

¶¶Composed of the EINSTEIN–DVT (N=3449), EINSTEIN–PE (N=4832), and EINSTEIN–EXT (N=1196) trials.

##Although the EINSTEIN–EXT trial was designed to evaluate patients who had previously completed 6 to 12 months of treatment with either rivaroxaban or warfarin before trial enrollment, some of the patients could have received up to 14 months of anticoagulation treatment before enrollment.2

 

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.

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. 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.
  3. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
  4. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297.
  5. Data on file. Janssen Pharmaceuticals, Inc.
  6. Protocol for: The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
  7. 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.
  8. Snow V, Qaseem A, Barry P, et al. Management of venous thromboembolism: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2007;146(3):204-210.