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

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