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Proven Efficacy Profile in Nonvalvular AF

XARELTO® reduced the risk of stroke and non-CNS systemic embolism in the ROCKET AF trial, a randomized, phase 3, multicenter, active-controlled, double-blind, double-dummy, event-driven study in more than 14,000 nonvalvular AF patients at moderate to high risk for stroke.1

Patient Characteristics in ROCKET AF1,2

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

In subgroup analyses, efficacy outcomes in patients with moderate renal impairment, those with previous stroke or TIA, those with heart failure, patients ≥75 years of age, and those with diabetes were consistent with the overall trial. In these subgroups, safety outcomes were generally consistent with the overall trial.3-7

AF = atrial fibrillation; CHADS2 = CHF, hypertension, age ≥75 years, diabetes mellitus, prior stroke or TIA; CHF = congestive heart failure; CNS = central nervous system; LVEF = left ventricular ejection fraction; TIA = transient ischemic attack.

XARELTO® effectively reduces stroke risk

Warfarin and XARELTO®  stroke risk rate in nonvalvular AF Warfarin and XARELTO®  stroke risk rate in nonvalvular AF
  • Reductions achieved in patients with prior stroke or multiple comorbidities (eg, hypertension, diabetes, heart failure)

  • 3.5 mean CHADS2 score for study population

XARELTO® in patients with moderate renal impairment

Efficacy consistent with the overall trial

21% (n=2950/14,264) of patients in ROCKET AF had moderate renal impairment (CrCl 30 to 49 mL/min) with a median age of 79 years and a 3.7 mean CHADS2 score3
XARELTO® efficacy by renal function is consistent with the overall trial XARELTO® efficacy by renal function is consistent with the overall trial
  • Efficacy results in patients with moderate renal impairment (CrCl 30 to 49 mL/min) receiving XARELTO® 15 mg once daily were consistent with those with better renal function (CrCl ≥50 mL/min) given XARELTO® 20 mg once daily, and consistent with the overall trial3

  • Increased risk for thrombotic events (ie, stroke and systemic embolism) in both XARELTO® and warfarin groups in patients with renal impairment3

XARELTO® in patients with prior stroke or TIA

Efficacy consistent with the overall trial

55% (n=7811/14,264) of patients in ROCKET AF had prior stroke, TIA, or non-CNS systemic embolism1
XARELTO® efficacy by prior occurrence of stroke is consistent with the overall trial XARELTO® efficacy by prior occurrence of stroke is consistent with the overall trial
  • Efficacy results in patients with prior stroke or TIA were consistent with those without prior stroke or TIA, and consistent with the overall trial4

XARELTO® in patients with heart failure

Efficacy consistent with the overall trial

64% (n=9033/14,171) of patients in ROCKET AF had CHF or LVEF <40%||5
XARELTO® efficacy by presence of heart failure is consistent with the overall trial XARELTO® efficacy by presence of heart failure is consistent with the overall trial
  • Efficacy results in patients with heart failure were consistent with those without heart failure, and consistent with the overall trial5

||Although the original ROCKET AF study classified patients with EF <35% as having HF, in this subanalysis EF was changed to <40% to be in line with the definition of systolic HF used in many randomized trials.

EF = ejection fraction; HF = heart failure.

XARELTO® in patients ≥75 years of age

Efficacy consistent with the overall trial

44% (n=6229/14,264) of patients in ROCKET AF were ≥75 years of age6
XARELTO® efficacy by prior occurrence of stroke is consistent with the overall trial XARELTO® efficacy by prior occurrence of stroke is consistent with the overall trial
  • Efficacy results in patients aged ≥75 years were consistent with those <75 years of age, and consistent with the overall trial6

  • Patients aged ≥75 years had higher stroke and systemic embolism rates than those <75 years of age6

XARELTO® in patients with diabetes

Efficacy consistent with the overall trial

40% (n=5695/14,264) of patients in ROCKET AF had diabetes7

 

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. Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891.
  2. Online supplement to: Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1009638/suppl_file/nejmoa1009638_appendix.pdf. Accessed May 5, 2016.
  3. Fox KAA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32(19):2387-2394.
  4. Hankey GJ, Patel MR, Stevens SR, et al, for the ROCKET AF Steering Committee and Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012;11(4):315-322.
  5. van Diepen S, Hellkamp AS, Patel MR, et al. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013;6(4):740-747.
  6. Halperin JL, Hankey GJ, Wojdyla DM, et al; on behalf of the ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation. 2014;130(2):138-146.
  7. 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.
  8. The Executive Steering Committee, on behalf of the ROCKET AF Study Investigators. Rivaroxaban—Once daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159(3):340-347.e1.