Overview
AMPLIFY
AMPLIFY-EXT
Eliquis® demonstrated efficacy across subgroups that was generally consistent with the overall results of the trial2
Consistent efficacy across subgroups in initial treatment of VTE between patients
treated for a PE or DVT2
For the treatment of VTE and prevention of recurrent Venous Thromboembolism*,
Eliquis® was studied in two phase III clinical trials2,3
AMPLIFY: In the study a total of 5,395 patients were randomised to treatment with apixaban 10 mg twice daily orally for 7 days followed by apixaban 5 mg twice daily orally for 6 months, or enoxaparin 1 mg/kg twice daily subcutaneously for at least 5 days (until INR≥ 2) and warfarin (target INR range 2.0-3.0) orally for 6 months. The mean age was 56.9 years and 89.8% of randomised patients had unprovoked Venous Thromboembolism events.3
AMPLIFY-EXT: In the study a total of 2,482 patients were randomised to treatment with apixaban 2.5 mg twice daily orally, apixaban 5 mg twice daily 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 enrollment in the AMPLIFY-EXT study. The mean age was 56.7 years and 91.7% of randomised patients had unprovoked Venous Thromboembolism events.2
BID: twice daily; DVT: deep-vein thrombosis; INR: International Normalized Ratio; PE: pulmonary embolism; SC: subcutaneous; VTE: venous thromboembolism.
References: 1. ELIQUIS® 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. 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. 3. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8):699-708.
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Click here for Eliquis® 2.5mg Prescribing Information Click here for Eliquis® 5mg Prescribing Information |
 HF0098OA455/122022
Invalidation Date : 21/08/2024 |
VTE treatment Safety
SPAF Guideline recommendations
the efficacy and safety of Eliquis® vs. Enoxaparin/warfarin was studied in patients with DVT or PE (with or without DVT)3
Enoxaparin followed by warfarin Adapted from Agnelli G, et al. N Engl J Med. 2013.
BID: twice daily; BMI: body mass index; CI: confidence interval; DVT: deep-vein thrombosis; INR: International Normalized Ratio; LMWH: low molecular weight heparin; PE: pulmonary embolism; SC: subcutaneous; UFH: unfractionated heparin; VTE: venous thromboembolism; RRR: relative risk reduction.
References: 1. ELIQUIS® 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8):699-708. 3. 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.
|
Click here for Eliquis® 2.5mg Prescribing Information Click here for Eliquis® 5mg Prescribing Information |
HF0098OA455/122022
Invalidation Date : 21/08/2024 |
SPAF Aristophanes
SPAF Guideline recommendations
The Efficacy And Safety Of Eliquis® vs. Placebo was studied in patients with DVT or PE (with or without DVT)2
BID: twice daily; CI: confidence interval; DVT: deep-vein thrombosis; NS: non-significant; PE: pulmonary embolism; RRR: relative risk reduction; VTE: venous thromboembolism.
References: 1. ELIQUIS® 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368:699-708.
|
Click here for Eliquis® 2.5mg Prescribing Information Click here for Eliquis® 5mg Prescribing Information |
HF0098OA455/122022
Invalidation Date : 21/08/2024 |
SPAF Guideline recommendations
VTE treatment Guideline recommendations
PP-ELI-EGY-0467