AMPLIFY-EXT Clinical Trial

Choose ELIQUIS® for prevention of recurrent DVT and PE

In AMPLIFY-EXT, in patients receiving extended treatment for prevention of recurrent DVT and PE, ELIQUIS 2.5 mg BD demonstrated superior efficacy and no significant difference in the rates of both major and major/CRNM bleeding vs placebo1,2*

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Discover the data supporting ELIQUIS in the prevention of recurrent VTE

ELIQUIS (apixaban) is indicated for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75 years, hypertension, diabetes mellitus, symptomatic heart failure (NYHA Class ≥II); treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults; and, prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery.2

Footnotes:

  • *The AMPLIFY-EXT clinical trial was a 12 month, randomised, double-blind trial in 2,482 patients with VTE who had been treated for 6–12 months with standard anticoagulation therapy or had completed treatment with ELIQUIS or enoxaparin / warfarin as participants in the AMPLIFY trial and for whom there was clinical uncertainty about the benefit of continuing treatment.1
  • The primary efficacy endpoint was the incidence of the adjudicated composite of recurrent symptomatic VTE or death from any cause related to VTE.1 Recurrent VTE included fatal or non-fatal PE and DVT.1
  • The primary safety endpoint was major bleeding.1 For patients who had more than one event, only the first was counted.1
  • §The secondary safety endpoint was the composite of major or CRNM bleeding events.1 For patients who had more than one event, only the first was counted.1
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  • BD = Twice Daily   CI = Confidence Interval   DVT = Deep Vein Thrombosis   N = Total number of patients in either the ELIQUIS group or the placebo group   n = Number of patients with event
  • PE = Pulmonary Embolism   RR = Relative Risk   SmPC = Summary of Product Characteristics   VTE = Venous Thromboembolism

References:

  1. Agnelli G et al. N Engl J Med 2013; 368: 699–708.
  2. ELIQUIS® (apixaban) Summary of Product Characteristics.

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance at www.hpra.ie

Adverse reactions should also be reported to Bristol-Myers Squibb Medical Information on 1 800 749 749 or medical.information@bms.com