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Results in NVAF Patients With Diabetes Consistent With the Overall Trial

Major bleeding in patients with diabetes (subgroup analysis)

A lower rate of major bleeding was observed with XARELTO® (n=165) versus warfarin (n=169), HR (95% CI), 1.00 (0.81-1.24)

*Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment (on-treatment period). Major bleeding is defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.
Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid, and/or epidural hematoma.
Hemorrhagic stroke in this table specifically refers to non-traumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days.

AF = atrial fibrillation; HR = hazard ratio; ICH = intracranial hemorrhage; NVAF = nonvalvular atrial fibrillation.

Safety profile in patients with diabetes (subgroup analysis)

||A 38% relative risk reduction (RRR) in ICH# was observed in patients receiving XARELTO® (n=22) versus warfarin (n=36), HR (95% CI), 0.62 (0.36-1.05)††‡‡

A 49% RRR in hemorrhagic stroke** was observed in patients receiving XARELTO® (n=10) versus warfarin (n=20), HR (95% CI), 0.51 (0.24-1.09)††‡‡

§All analyses of rates of bleeding are based on the first event in the safety population during treatment.
#Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid, and/or epidural hematoma.
**Hemorrhagic stroke specifically refers to non-traumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days.
††Rates of ICH and hemorrhagic stroke in patients with diabetes randomized to XARELTO® versus warfarin were similar to those in patients without diabetes.
‡‡RRR was calculated using 1 minus the HR.

 

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.

Reference:

  1. Bansilal S, Bloomgarden Z, Halperin JL, et al. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: The ROCKET AF trial. Am Heart J. 2015;170(4):675-682.e8.