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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 venous thromboembolic events (VTE) in patients who have undergone elective hip or knee replacement surgery.


FOOTNOTES

* The AMPLIFY clinical trial was a randomised, double-blind, non-inferiority trial in 5,395 patients with acute VTE. Patients received either ELIQUIS 10 mg BD for 7 days, followed by ELIQUIS 5 mg BD for 6 months; or subcutaneous enoxaparin (1 mg/kg) BD for at least 5 days (until INR was 2–3) with concomitant warfarin for 6 months. Efficacy analyses were based on ITT population for whom the outcome status at 6 months was documented. All safety analyses included data obtained from patients during study treatment, defined as the time from administration of the first dose until 48 hours after the last dose was administered.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 PE and DVT.1

The primary safety endpoint was the incidence of adjudicated major bleeding.1 For patients who had more than one event, only the first was counted.1

§ The secondary safety endpoint was the incidence 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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CI = Confidence Interval   CRNM = Clinically Relevant Non-Major Bleeding   
DVT = Deep Vein Thrombosis   ITT = Intention-to-Treat   N = Total number of patients in the ELIQUIS group or the enoxaparin / warfarin group   n = Number of patients with event   PE = Pulmonary Embolism   RR = Relative Risk   VTE = Venous Thromboembolism

REFERENCES

  1. Agnelli G et al. N Engl J Med 2013; 369: 799–808.
  2. ELIQUIS® (apixaban) Summary of Product Characteristics. Available at www.medicines.org.uk.