AMPLIFY CLINICAL TRIAL
In AMPLIFY, ELIQUIS (apixaban) demonstrated comparable efficacy with significantly fewer major bleeding events vs. enoxaparin / warfarin in patients receiving treatment for DVT / PE1
* Efficacy analyses based on ITT population for whom the outcome status at 6 months was documented. Safety analyses based on patients who had at least one dose of study drug.
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Patient characteristics |
ELIQUIS |
Conventional therapy |
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Randomised subjects |
2,691 |
2,704 |
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Mean age, yr |
57.2 |
56.7 |
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Qualifying diagnosis, % |
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Median time from onset of symptoms to randomisation, days |
5.0 |
5.0 |
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Risk factors for recurrent VTE, % |
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Primary efficacy endpoint |
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Primary safety endpoint |
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|
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Key predefined secondary efficacy endpoints |
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Patients were eligible for inclusion in the trial if they met the following criteria:1
- age ≥18 years
- objectively confirmed, symptomatic proximal DVT, or PE (with or without DVT); proximal DVT was defined as thrombosis involving at least the popliteal vein or a more proximal vein
Patients were excluded if they met the following criteria:1
- had active bleeding, high risk of bleeding, or other contraindications to treatment with enoxaparin and warfarin
- had cancer and long-term treatment with low-molecular-weight heparin was planned
- had deep vein thrombosis or pulmonary embolism that was provoked in the absence of a persistent risk factor for recurrence
- if <6 months of anticoagulant treatment was planned
- had another indication for long-term anticoagulation therapy, dual antiplatelet therapy, treatment with aspirin at a dose >165 mg daily or treatment with potent inhibitors of cytochrome P-450 3A4
- received >2 doses of a once-daily low-molecular-weight heparin regimen, fondaparinux, or a vitamin K antagonist
- received >3 doses of a twice-daily low-molecular-weight heparin regimen
- received >36 hours of continuous intravenous heparin
ELIQUIS has demonstrated comparable efficacy with significantly fewer major bleeding events vs. enoxaparin / warfarin in patients receiving treatment for DVT / PE1
Adapted from Agnelli et al. 2013.1
† The primary efficacy endpoint was the incidence of the adjudicated composite of recurrent symptomatic venous thromboembolism or death related to venous thromboembolism.1 Recurrent venous thromboembolism included fatal or non-fatal pulmonary embolism and deep vein thrombosis.1 The primary safety endpoint was major bleeding.1
The efficacy of ELIQUIS vs. enoxaparin / warfarin was maintained regardless of whether the index event was a DVT or PE (p-value for interaction=0.82).2‡
‡ In patients with PE (with or without DVT), 21 events were reported in the ELIQUIS group vs. 23 events in the enoxaparin / warfarin group. In patients with DVT only, 38 events were reported in the ELIQUIS group vs. 47 events in the enoxaparin / warfarin group.2
In patients receiving treatment for DVT and PE, ELIQUIS demonstrated comparable efficacy and a significant reduction in the risk of major bleeding compared with enoxaparin / warfarin.1
432UK1800479-02 – May 2018
Please click here to access the ELIQUIS Patient Information Leaflet.
AMPLIFY = Apixaban for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-Line Therapy
ARR = Absolute Risk Reduction
BD = Twice Daily
CI = Confidence Interval
DVT = Deep Vein Thrombosis
INR = International Normalised Ratio
ITT = Intention-To-Treat
LMWH = Low Molecular Weight Heparin
N = Total number of patients in either the ELIQUIS group or the enoxaparin / warfarin group
n = Number of patients with event
PE = Pulmonary Embolism
RR = Relative Risk
RRR = Relative Risk Reduction
SC = Subcutaneous
VTE = Venous Thromboembolic Events
¶ Not all patients who start on ELIQUIS for acute DVT / PE will stay on ELIQUIS; some acute DVT / PE patients who receive treatment do not require treatment for the prevention of recurrent DVT / PE. Other patients may be prescribed ELIQUIS for the prevention of recurrent VTE after initial treatment for acute DVT / PE with another anticoagulant.3 This is a decision for the prescribing clinician together with patient involvement in the decision-making.
References
- Agnelli G et al. N Engl J Med 2013; 369: 799–808.
- Agnelli G et al. N Engl J Med 2013; 369: 799–808.Supplementary appendix.
- ELIQUIS® (apixaban) Summary of Product Characteristics.