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AboutAboutMOA & IndicationsWhy Eliquis®?Dosage & SwitchDosage & SwitchSPAF DosingVTE DosingEfficacy & SafetyEfficacy & SafetyRCT Data: Efficacy and Safety in SPAFRCT Data: Efficacy and Safety in VTERCT Data: Efficacy and Safety in SPAFEliquis® in a Broad Range of Patients With NVAFApixaban & Other NOACsApixaban & Other NOACsApixaban & Other NOACsSupport & ServicesSupport & ServicesSummary of Prescribing InformationExpert Webinars

RCT Data: Efficacy and Safety in SPAF

Apixaban demonstrated consistent benefits across patients with NVAF with a wide range of stroke risks versus warfarin1,5-7,*
 


Adapted from Granger CB, et al. 2011.
​​​​​​​


​​​​​​​Adapted from Lopes RD, et al. 2012.
 


Adapted from Lopes RD, et al. 2012.

Safety in SPAF

Apixaban demonstrated a favourable safety profile across components of major bleeding versus warfarin1,5 
 

  

Adapted from Granger CB, et al. 2011; Conolly SJ, et al. 2011.

  

  

*As assessed by the CHADS2, CHA2DS2-VASc and HAS-BLED scores,7 stroke or SE was the primary efficacy endpoint and major bleeding was the primary safety endpoint of the ARISTOTLE trial.

The ARISTOTLE trial was not designed or powered to detect interactions between study drug and CHA2DS2-VASc score
subgroups.1,7

Apixaban was studied in a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients.1 Stroke/SE was the primary efficacy endpoint and major bleeding was the primary safety endpoint.1 Intracranial bleeding and major bleeding at other locations including GI bleeding were components of the primary safety endpoint.1 The endpoints presented were selected due to their frequency and severity: intracranial bleeding, the most feared complication of anticoagulation therapy due to its high risk of death and disability8; and GI bleeding, the most frequent adverse event associated with OAC use.9-11

     

AF, atrial fibrillation; ARISTOTLE, Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation; AVERROES, Apixaban Versus Acetylsalicylic Acid to Prevent Strokes; CI, confidence interval; CHA2DS2, Congestive Heart Failure; CHA2DS2-VASc, Congestive Heart Failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular Disease, Age 65-74, Sex Category, Female; GI- gastrointestinal; HR, hazard ratio; Hypertension, Age ≥75, Diabetes, Stroke (doubled); ICH, intracerebral hemorrhage; NOAC, non-vitamin K antagonist oral anticoagulants; NVAF, nonvalvular atrial fibrillation; OAC, oral anticoagulant; PCI, percutaneous coronary intervention; ISTH, International Society on Thrombosis and Haemostasis; NOAC, non-vitamin K antagonist oral anticoagulants; NVAF, nonvalvular atrial fibrillation; RRR, relative risk reduction; SE, systemic embolism; SPAF, stroke prevention in patients with atrial fibrillation VKA, vitamin K antagonists.

Refrences:

Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-992.Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-962.Hur M, Park SK, Koo CH, et al. Comparative efficacy and safety of anticoagulants for prevention of venous thromboembolism after hip and knee arthroplasty. Acta Orthop. 2017;88(6):634-641.Cohen AT, Imfeld S, Rider T. Phase III trials of new oral anticoagulants in the acute treatment and secondary prevention of VTE: comparison and critique of study methodology and results. Adv Ther. 2014;31(5):473-493.Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364(9):806-817.Lopes RD, Heizer G, Aronson R, et al. Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation. N Engl J Med. 2019;380(16):1509-1524.Lopes RD, Al-Khatib SM, Wallentin L, et al. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomized controlled trial. Lancet. 2012;380(9855):1749-1758.Camm AJ, Lip GY, De Caterina R, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association [published correction appears in Eur Heart J. 2013 Mar;34(10):790] [published correction appears in Eur Heart J. 2013 Sep;34(36):2850-1]. Eur Heart J. 2012;33(21):2719-2747.Hylek EM, Held C, Alexander JH, et al. Major bleeding in patients with atrial fibrillation receiving apixaban or warfarin: the ARISTOTLE trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation): predictors, characteristics, and clinical outcomes. J Am Coll Cardiol. 2014;63(20):2141-2147.Goodman S, Wojdyla D, Piccini J, et al. Factors associated with major bleeding events. J Am Coll Cardiol. 2014;63(9):891-900.Majeed A, Hwang HG, Connolly SJ, et al. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013;128(21):2325-2332.  

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