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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 VTE

Amplify
 
Apixaban demonstrated superior reduction in major bleeding and comparable efficacy in the treatment and prevention of recurrent VTE versus warfarin5 

   


Adapted from Agnelli G, et al. 2013.
 

Study design
 

AMPLIFY: In this study, a total of 5395 patients were randomised to treatment with apixaban 10 mg BID orally for 7 days followed by apixaban 5 mg BID orally for 6 months, or enoxaparin 1 mg/kg BID subcutaneously for at least 5 days (until INR ≥2) and warfarin (target INR, 2.0-3.0) orally for 6 months. The mean age was 56.9 years and 89.8% of randomised patients had unprovoked VTE events.5

  

AMPLIFY-EXT: In this study, a total of 2482 patients were randomised to treatment with apixaban 2.5 mg BID orally, apixaban 5 mg BID orally or placebo for 12 months after completing 6 to 12 months of initial anticoagulant treatment. Of these, 836 patients (33.7%) participated in the AMPLIFY study prior to enrolment in the AMPLIFY-EXT study. The mean age was 56.7 years and 91.7% of randomised patients had unprovoked VTE events.6

  

In the treatment and prevention of recurrent DVT and PE.


Apixaban was studied in 2 Phase III clinical trials5,6
 


In the treatment and prevention of recurrent DVT and PE.

Apixaban demonstrated efficacy across subgroups that was generally consistent with the overall results of the trial
 

 

Amplify Extension

In AMLIFY-EXT, a study for extended treatment of VTE.

The efficacy and safety of apixaban versus placebo was studied in patients with VTE (DVT, PE or both) who had completed 6 to 12 months of anticoagulation therapy6
 

  

Adapted from Agnelli G, et al. 2013.

  

Study design

  

AMPLIFY-EXT: In this study, a total of 2482 patients were randomised to treatment with apixaban 2.5 mg BID orally, apixaban 5 mg BID orally or placebo for 12 months after completing 6 to 12 months of initial anticoagulant treatment. Of these, 836 patients (33.7%) participated in the AMPLIFY study prior to enrolment in the AMPLIFY-EXT study. The mean age was 56.7 years and 91.7% of randomised patients had unprovoked VTE events.6

Apixaban demonstrated efficacy* across subgroups that was generally consistent with the overall results of the trial

  

    


*Apixaban was superior to placebo in protecting patients from VTE recurrence, with a similar incidence of major bleeding.6

    

AMPLIFY, Apixaban for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-Line Therapy; AMPLIFY-EXT, Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First Line Therapy - Extended Treatment; BID, twice daily; DVT, deep vein thrombosis; INR, international normalised ratio; NS, non-significant; PE, pulmonary embolism; RCT, randomised controlled trial;RRR, relative risk reduction; VTE, venous thromboembolism.
 

References:

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.Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9):799-808.Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8):699-708.Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9):799-808. Supplementary Appendix.

  

Disclaimer: The products discussed herein may have different product labelling in different countries. The product information provided in this site is intended only for the residents of India.

   

Please click the Prescribing Information link to view the safety and adverse events information of Eliquis®.
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