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Results in NVAF Patients With Diabetes Consistent With the Overall Trial

Patients with nonvalvular AF typically have multiple chronic comorbid conditions.*1 XARELTO® has been studied in a large number of these patients in the ROCKET AF trial.2,3

The XARELTO® nonvalvular trial (ROCKET AF) enrolled 14,264 patients with multiple comorbidities†2,3

*Based on 2007 data of 5% sample size of Medicare beneficiaries.
Percentage of patients calculated by pooling total patients with noted characteristics in each trial arm.

AF = atrial fibrillation; CHF = congestive heart failure; LVEF = left ventricular ejection fraction.

Diabetes and its treatment can complicate stroke risk reduction in nonvalvular AF

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The risk of stroke is 1.5x higher in patients with diabetes than in those without4

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Life expectancy can be reduced by ~12 years in patients aged 60 years with diabetes and a history of stroke‡5

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An anticoagulant that requires multiple pills many times a day may add to the pill burden patients with diabetes already face

  • XARELTO® is 1 pill taken once daily
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Patients with diabetes may have to watch their diets more closely with the use of warfarin6

  • XARELTO® has no known dietary restrictions

Based on data from the Emerging Risk Factors Collaboration (689,300 participants) and the UK Biobank (499,808 participants).

Stroke reductions in the high-risk patients with diabetes you see every day (post hoc subgroup analysis)

Patients with diabetes had a mean CHADS2 score of 3.77

§A 19% relative risk reduction (RRR) in stroke or systemic embolism was observed in patients with diabetes receiving XARELTO® (n=95) versus warfarin (n=114), HR (95% CI), 0.81 (0.62-1.07)||

||RRR was calculated using 1 minus the HR.

CHADS2 = CHF, hypertension, age ≥75 years, diabetes mellitus, prior stroke or TIA; HR = hazard ratio.

 

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. Piccini JP, Hammill BG, Sinner MF, Jensen PN, et al. Incidence and prevalence of atrial fibrillation and associated mortality among Medicare beneficiaries, 1993-2007. Circ Cardiovasc Qual Outcomes. 2012;5(1):85-93.
  2. 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.
  3. 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 June 10, 2016.
  4. American Diabetes Association. Stroke. www.diabetes.org/living-with-diabetes/complications/stroke.html. Accessed June 10, 2016.
  5. The Emerging Risk Factors Collaboration. Association of cardiometabolic multimorbidity with mortality. JAMA. 2015;314(1):52-60.
  6. Coumadin® [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; 2015.
  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.