RCT Data: Efficacy and Safety in VTE

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 trials^5,6
 

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 trial⁷ 
 

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 trial⁶ 

*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.
 

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