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In patients with NVAF, ELIQUIS is the only factor Xa inhibitor that has demonstrated all of the following:1–3

  • Superior risk reduction in the prevention of stroke / systemic embolism vs. warfarin1–3*
  • Superior risk reduction in the incidence of major bleeding vs. warfarin1–3*
  • Significant risk reduction in the incidence of all-cause mortality vs. warfarin1–3*
Bar chart of primary efficacy and safety results of ELIQUIS vs. warfarin from the ARISTOTLE clinical trial

Adapted from Granger et al. 2011.1

Discover the data supporting ELIQUIS for the prevention of stroke and systemic embolism in patients with NVAF from the ARISTOTLE study

The full publication is available to read here

ELIQUIS 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)4

Purple information icon ELIQUIS (apixaban) SmPC

Please click here to access the ELIQUIS SmPC.

Purple information icon ELIQUIS (apixaban) Patient Information Leaflet

Please click here to access the ELIQUIS Patient Information Leaflet.

* The ARISTOTLE clinical trial was a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients with NVAF. A 5 mg BD dose was used in 95.3% of ELIQUIS patients.1 A 2.5 mg BD dose of ELIQUIS was used in patients who met two of the following criteria: ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dl (133 µmol/l).1 Patients with the exclusive criteria of severe renal impairment (creatinine clearance 15–29 ml/min) should also receive a lower dose of 2.5 mg twice daily.4 Stroke / systemic embolism, including haemorrhagic, ischaemic or undetermined stroke, was the primary efficacy endpoint, major bleeding according to ISTH criteria was the primary safety outcome and all-cause mortality was a key secondary endpoint.1 Pre-specified hierarchical sequential testing was performed first on stroke / systemic embolism (primary efficacy endpoint) for non-inferiority, then for superiority, then on major bleeding, and finally, on death from any cause (secondary endpoint).1
† This link is to a third-party site unaffiliated with the Pfizer / BMS Alliance. Please abide by the terms of use of the site.

ARISTOTLE = Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation   ARR = Absolute Risk Reduction   BD = Twice Daily   CI = Confidence Interval   HR = Hazard Ratio
N = Total number of patients in either the ELIQUIS group or the warfarin group    n = Number of patients with event   NVAF = Non-Valvular Atrial Fibrillation    ISTH = International Society on Thrombosis and Haemostasis    RRR = Relative Risk Reduction

References

  1. Granger CB et al. N Engl J Med 2011; 365: 981–992.
  2. Patel MR et al. N Engl J Med 2011; 365: 883–891.
  3. Giugliano RP et al. N Engl J Med 2013; 369: 2093–2104.
  4. ELIQUIS® (apixaban) Summary of Product Characteristics.