This information is intended for healthcare professionals based in Ireland. If you are not a healthcare professional in Ireland, click here

This information is intended for healthcare professionals based in Ireland. If you are not a healthcare professional in Ireland, click here

ARISTOTLE Clinical Trial

ELIQUIS® offers superior reductions in the rates of stroke / systemic embolism AND major bleeding vs. warfarin, PLUS a significant reduction in all-cause mortality.1

In patients with NVAF, ELIQUIS demonstrated:1

  • Superior risk reduction in stroke / systemic embolism vs. warfarin1*
  • Superior risk reduction in major bleeding vs. warfarin1*
  • Significant risk reduction in all-cause mortality vs. warfarin11*
aristotle result aristotle result

Discover the data supporting ELIQUIS in patients with NVAF from the ARISTOTLE study

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 ARISTOTLE clinical trial was a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients with NVAF. 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 The median duration of follow-up was 1.8 years.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. https://www.nejm.org/doi/pdf/10.1056/NEJMoa1107039
  • ARR = Absolute Risk Reduction   CI = Confidence Interval   HR = Hazard Ratio   ISTH = International Society on Thrombosis and Haemostasis   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   RRR = Relative Risk Reduction

References:

  1. Granger CB et al. N Engl J Med 2011; 365: 981–992
  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