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XARELTO® Real-World Evidence

Published SAFETY and/or EFFICACY OUTCOMES in real-world patients, from observational studies in patients taking XARELTO®

*Based on the following registries, claims databases, and studies: Optum Labs (1)=16,253; IMS Health LifeLink=1649; Truven Health=5563; Danish nationwide administrative registries=1303; XAMOS=8778; Symphony=3654; ORTHO-TEP=1043; Japanese registry=1035; Dresden NOAC=1776; XALIA=2505; DoD database=44,793; XANTUS=6784; RELIEF=1039; SWIVTER=417; REVISIT-US=11,411; Optum Labs (2)=16,175; Danish national prescription registry=5693; Medicare database=66,651.

PMSS: Real-world patient population11

Results based on 15 months of data from an ongoing, 5-year postmarketing safety surveillance (PMSS) study to evaluate major bleeding in a real-world clinical setting through EMRs from the Department of Defense (DoD) database from January 1, 2013, to March 31, 2014.

27,467

Nonvalvular AF patients
taking XARELTO®

Patients evaluated were similar to the comorbid patients you may see every day

Limitations: This is a retrospective study, and there is no comparator arm in the trial. This study used a claims-based definition of major bleeding.

Results are not intended for direct comparison with clinical trials because the real-world studies were observational trials with no comparator arm. Differences in study designs, patient populations, definitions of safety or efficacy outcomes, as well as data collection methods, make it difficult to make comparisons either with clinical trials or with each other.

Validated computer database algorithm developed by Cunningham et al, which identifies bleeding-related hospitalizations from a primary discharge diagnosis, was used to identify major bleeding events in this study. The definition of major bleeding is not an exact match with the ROCKET AF trial.

View the PMSS study

XANTUS: Real-world patient population10

International, noninterventional, observational study (XANTUS) investigated safety and efficacy in a real-world clinical setting through 311 clinical centers in Europe, Israel, and Canada.

6784

Nonvalvular AF patients
taking XARELTO®

Patients evaluated were similar to the comorbid patients you may see every day

Limitations: This is a single-arm, open-label study, and there is no comparator arm in the trial. Selection biases may have occurred due to patient self-selection participation or investigator selection around intact cognitive function. There were no dose adjustments for baseline risk factors.

Consecutive consenting patients with NVAF newly started on XARELTO® were eligible and were followed up at 3-month intervals for 1 year or for at least 30 days after permanent discontinuation.

Results are not intended for direct comparison with clinical trials because the real-world studies were observational trials with no comparator arm. Differences in study designs, patient populations, and definitions of safety or efficacy outcomes, as well as data collection methods, make it difficult to make comparisons either with clinical trials or with each other.

§The primary outcomes included major bleeding events (defined using International Society on Thrombosis and Haemostasis [ISTH] criteria), all-cause death, and any other AEs and SAEs. Secondary outcomes included symptomatic thromboembolic events (stroke, non-central nervous system SE, TIA, and MI) and nonmajor bleeding events.

||Defined using the ISTH criteria, which are the same criteria as in the pivotal AF trial.

View the XANTUS study

View efficacy and safety outcomes in the ROCKET AF trial

AE = adverse event; AF = atrial fibrillation; CHF = congestive heart failure; CNS = central nervous system; CV = cerebrovascular; DVT = deep vein thrombosis; EMR = electronic medical record; GI = gastrointestinal; ICH = intracranial hemorrhage; MI = myocardial infarction; NVAF = nonvalvular atrial fibrillation; PE = pulmonary embolism; SAE = serious adverse event; SE = systemic embolism; TIA = transient ischemic attack; VTE = venous thromboembolism.

Download the Real-World Evidence brochure

 

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. Beyer-Westendorf J, Förster K, Pannach S, et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014;124(6):955-962.
  2. Peacock WF, Tamayo S, Patel M, et al. CHA2DS2-VASc scores and major bleeding in patients with nonvalvular atrial fibrillation who are receiving rivaroxaban. Ann Emerg Med. 2016;1-10. [Published online ahead of print November 29, 2016]. doi: 10.1016/j.annemergmed.2016.09.032.
  3. Camm AJ, Amarenco P, Haas S, et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Euro Heart J. 2016;37(14):1145-1153.
  4. Laliberté F, Cloutier M, Nelson WW, et al. Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients. Curr Med Res Opin. 2014;30(7):1317-1325.
  5. Ogawa S, Ikeda T, Kitazono T, et al; on behalf of the Rivaroxaban Postmarketing Surveillance Registry Investigators. Present profiles of novel anticoagulant use in Japanese patients with atrial fibrillation: insights from the rivaroxaban postmarketing surveillance registry. J Stroke Cerebrovasc Dis. 2014;23(10):2520-2526.
  6. Abraham NS, Singh S, Alexander CG, et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ. 2015;350:h1857.
  7. Chang H-Y, Zhou M, Tang W, Alexander GC, Singh S. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ. 2015;350:h1585.
  8. Lauffenburger JC, Farley JF, Gehi AK, Rhoney DH, Brookhart MA, Fang G. Factors driving anticoagulant selection in patients with atrial fibrillation in the United States. Am J Cardiol. 2015;115(8):1095-1101.
  9. Olesen JB, Sørensen R, Hansen ML, et al. Non-vitamin K antagonist oral anticoagulation agents in anticoagulant naïve atrial fibrillation patients: Danish nationwide descriptive data 2011–2013. Europace. 2015;17(2):187-193.
  10. Ageno W, Mantovani LG, Haas S, et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol. 2016;3(1):e12-e21.
  11. Turpie AGG, Haas S, Kreutz R, et al. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014; 111(1):94-102.
  12. Beyer-Westendorf J, Lützner J, Donath L, et al. Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery. Findings from the ORTHO-TEP registry. Thromb Haemost. 2013;109(1):154-163.
  13. Coleman CI, Antz M, Ehlken B, Evers T. REal-LIfe Evidence of stroke prevention in patients with atrial Fibrillation — The RELIEF study. Int J Cardiol. 2016;203:882-884.
  14. Kucher N, Aujesky D, Beer JH, et al. Rivaroxaban for the treatment of venous thromboembolism: the SWIss Venous ThromboEmbolism Registry (SWIVTER). Thromb Haemost. 2016;116(3):472-9.
  15. Coleman CI, Antz M, Bowrin K, et al. Real-world EVIdence of Stroke prevention In patients with nonvalvular aTrial fibrillation in the United States: the REVISIT-US Study. Curr Med Res Opin. 2016;15:1-23.
  16. Yao X, Abraham NS, Sangaralingham LR, et al. J Am Heart Assoc. 2016;5:e003725. doi: 10.1161/JAHA.116.003725.
  17. Staerk L, Fosbøl EL, Lip GYH, et al. Ischaemic and haemorrhagic stroke associated with non-vitamin K antagonist oral anticoagulants and warfarin use in patients with atrial fibrillation: a nationwide cohort study. European Heart J. 2016;0:1-9.
  18. Graham DJ, Reichman ME, Wernecke M, et al. JAMA Intern Med. doi:10.1001/jamainternmed.2016.5954. Published online October 3, 2016.