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Proven Safety Profile Versus Enoxaparin After Knee or Hip Replacement Surgery

The safety profile of XARELTO® in a once-daily dose was proven in three phase 3 clinical trialsfor the prophylaxis of deep vein thrombosis (DVT) after hip replacement surgery, as extended therapy after hip replacement surgery, and after knee replacement surgery in more than 9000 patients.

Comparable major bleed* rates versus enoxaparin after hip replacement surgery

Chart showing bleed events in RECORD clinical trial with Xarelto major at .3, any at 5.9, non-major clinically relevant 2.8, hemorrhagic 1.5 versus .1, 5.8, 2.5, and 1.8 respectively. Chart showing bleed events in RECORD clinical trial with Xarelto major at .3, any at 5.9, non-major clinically relevant 2.8, hemorrhagic 1.5 versus .1, 5.8, 2.5, and 1.8 respectively.

In a secondary analysis, XARELTO® demonstrated comparable rates of any bleeding, nonmajor clinically relevant bleeding, and hemorrhagic wound complications versus enoxaparin in the RECORD1 clinical trial.1

  • Following XARELTO® treatment, the majority of major bleeding complications (≥60%) occurred after the first week of surgery

*Major bleeding was defined as bleeding that was fatal, bleeding into a critical organ (ie, retroperitoneal, intracranial, intraocular, or intraspinal), bleeding that required reoperation, or clinically overt extrasurgical site bleeding associated with a fall in hemoglobin ≥2 g/dL or requiring the transfusion of ≥2 units of blood or packed cells.

Comparable major bleed§ rates for extended-duration versus short-term prophylaxis after hip replacement surgery

Chart showing bleed events in RECORD 2 clinical trial with major events less than .1, any events at 6.5, nonmajor clinically relevant events at 3.2, and hemorrhagic events 1.6. versus less than .1, 5.7, 2.8, and 1.8 respectively. Chart showing bleed events in RECORD 2 clinical trial with major events less than .1, any events at 6.5, nonmajor clinically relevant events at 3.2, and hemorrhagic events 1.6. versus less than .1, 5.7, 2.8, and 1.8 respectively.

Despite different lengths of treatment, major bleeding rates were comparable for short-term and extended prophylaxis after hip replacement surgery in the RECORD2 clinical trial.

§Major bleeding was defined as bleeding that was fatal, bleeding into a critical organ (ie, retroperitoneal, intracranial, intraocular, or intraspinal), bleeding that required reoperation, or clinically overt extrasurgical site bleeding associated with a fall in hemoglobin ≥2 g/dL or requiring the transfusion of ≥2 units of blood or packed cells.

Comparable major bleed# rates versus enoxaparin after knee replacement surgery

Chart showing bleed events in RECORD 3 clinical trials show XARELTO major events are .6, any event is 5, nonmajor clinical relevant events are 2.7, henomhogic events are 2.1 and for enoxaparin .5, 4.9, 2.4, and 2 respectively Chart showing bleed events in RECORD 3 clinical trials show XARELTO major events are .6, any event is 5, nonmajor clinical relevant events are 2.7, henomhogic events are 2.1 and for enoxaparin .5, 4.9, 2.4, and 2 respectively

In a secondary analysis, XARELTO® demonstrated comparable rates of any bleeding, nonmajor clinically relevant bleeding, and hemorrhagic wound complications versus enoxaparin after knee replacement surgery in the RECORD3 clinical trial.1

  • Following XARELTO® treatment, the majority of major bleeding complications (≥60%) occurred after the first week of surgery

#Major bleeding was defined as bleeding that was fatal, bleeding into a critical organ (ie, retroperitoneal, intracranial, intraocular, or intraspinal), bleeding that required reoperation, or clinically overt extrasurgical site bleeding associated with a fall in hemoglobin ≥2 g/dL or requiring the transfusion of ≥2 units of blood or packed cells.

Pooled rates of adverse drug reactions versus enoxaparin in the RECORD trials

Other adverse reactions in the RECORD-3 clinical trials Other adverse reactions in the RECORD-3 clinical trials

The overall rate of discontinuation due to adverse events was 3.7% for XARELTO® in the RECORD clinical trials.

 

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. Data on file. Janssen Pharmaceuticals, Inc
  2. Eriksson BI, Borris LC, Friedman RJ, et al; for the RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  3. Kakkar AK, Brenner B, Dahl OE, et al; for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  4. Lassen MR, Ageno W, Borris LC, et al; for the RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.