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This page covers the practical use and key benefits of ELIQUIS® (apixaban).

ELIQUIS (apixaban) is a NOAC – specifically an oral, direct factor Xa inhibitor – approved for the prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥75 years; hypertension; diabetes mellitus; or symptomatic heart failure (NYHA Class ≥2).1 NICE recommends the use of ELIQUIS, in line with the indication stated above.2,3

Superior efficacy and major bleeding profile vs. warfarin

The safety and efficacy of ELIQUIS vs. warfarin for the prevention of stroke and systemic embolism in patients with NVAF was assessed in the ARISTOTLE randomised controlled trial.4 In this pivotal trial, ELIQUIS demonstrated both superior stroke protection and a superior major bleeding profile vs. warfarin.4

ARISTOTLE

Adapted from Granger et al. 2011.4

ARISTOTLE was a randomised, double-dummy, non-inferiority trial in 18,201 patients. The primary objective was to determine whether ELIQUIS was non-inferior to warfarin in reducing the rate of stroke (ischaemic or haemorrhagic) or systemic embolism among NVAF patients with at least one other risk factor for stroke. The primary safety outcome was major bleeding, according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).4 Pre-specified hierarchical sequential testing was performed first on stroke / systemic embolism (primary efficacy endpoint) for noninferiority, then for superiority, then on major bleeding and, finally, on death from any cause (secondary endpoint).4

In patients with NVAF, ELIQUIS is the only factor Xa inhibitor to offer both superior stroke protection and a superior major bleeding profile vs. warfarin.4–6 Additionally, in ARISTOTLE, ELIQUIS significantly reduced all-cause mortality vs. warfarin in patients with NVAF.4

For a broad range of your patients

ELIQUIS can benefit a broad range of patients with NVAF, with a broad range of risks. Patients with NVAF treated with ELIQUIS had fewer episodes of stroke or systemic embolism and fewer major bleeds vs. warfarin, with similar results across a broad range of subgroup populations and risk profile.4,7–11

NVAF

[References for image: 4. Granger CB, et al. N Engl J Med 2011; 365: 981–992. 7. Lopes RD, et al. Lancet 2012; 380: 1749–1758. 8. Easton JD, et al. Lancet Neurol 2012; 11: 503–511. 9. Garcia DA, et al. Am Heart J 2013; 166: 549–558. 10. Hohnloser SH et al. Eur Heart J 2012; 33: 2821–2830. 11. Halvorsen S et al. Eur Heart J 2014; 35: 1864–1872.]

# Patients with severe renal insufficiency (CrCl <25 mil/min) were excluded from ARISTOTLE. ELIQUIS is not recommended for patients with CrCl <15 ml/min or in patients undergoing dialysis1,4

Simple dosing

For the prevention of stroke in patients with NVAF, ELIQUIS has simple dosing and may be taken with or without food.1 The optimal dose of ELIQUIS for most patients with NVAF is 5 mg taken orally twice daily – ELIQUIS 2.5 mg BD should only be used in patients with NVAF who meet two or more of the dose reduction criteria or have severe renal impairment, as shown below.1

NVAF
NVAF

‡ELIQUIS is not recommended for patients with CrCl <15 ml/min or in patients undergoing dialysis.1

[Reference for image: 1. Apixaban SmPC. Available at: www.medicines.org.uk/emc/product/2878/smpc. 4. Granger CB et al. N Engl J Med 2011;365:981–992.]

*ELIQUIS should be used with caution in NVAF patients receiving concomitant systemic therapy with strong inducers of both CYP3A4 and P-gp.1 ELIQUIS is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp.1
† The ARISTOTLE clinical trial was a randomised, double-blind, double-dummy non-inferiority trial in 18,201 patients. Stroke / systemic embolism was the primary efficacy endpoint and major bleeding was the primary safety endpoint. The primary safety outcome was major bleeding, according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).
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).4

Additional benefits

Finally, in addition to simple dosing and offering both superior stroke protection and a superior major bleeding profile vs. warfarin, ELIQUIS also offers patients additional benefits such as freedom from INR monitoring, no dietary restrictions, and the choice to be taken with or without food.1

benefit a

Freedom from INR monitoring

benefit b

No dietary restrictions and the choice to be taken with or without food

benefit c

If a dose is missed, take ELIQUIS immediately and then continue with twice-daily intake as before

[Reference for image: ELIQUIS (apixaban) SmPC. Available at: www.medicines.org.uk/emc/product/2878/smpc.]

To support you in assessing your patients’ suitability prior to initiating treatment with ELIQUIS, a Prescriber Checklist is available here.

For patients who are switching from warfarin to ELIQUIS, a Patient Information Leaflet is available here.

For more information on ELIQUIS for your patients with NVAF, please request a visit from a representative.

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Click here to view ELIQUIS prescribing and adverse event reporting information.

Abbreviations

AF = Atrial Fibrillation INR = International Normalised Ratio NICE = National Institute for Health and Care Excellence
NOAC = Non-VKA Oral Anticoagulant NVAF = Non-Valvular Atrial Fibrillation NYHA = New York Heart Association TIA = Transient Ischaemic Attack

References
  1. Apixaban Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/2878/smpc. Accessed August 2019.
  2. NICE CG180. 2014. Available at: https://www.nice.org.uk/guidance/cg180. Accessed August 2019.
  3. NICE. Technology appraisal guidance [TA275]. Apixaban for preventing stroke and systemic embolism in people with nonvalvular atrial fibrillation. Available at: https://www.nice.org.uk/guidance/ta275. Accessed August 2019.
  4. Granger CB et al. N Engl J Med 2011; 365: 981–992.
  5. Patel MR et al. N Engl J Med 2011; 365: 883–891.
  6. Giugliano RP et al. N Engl J Med 2013;369:2093–2104.
  7. Lopes RD et al. Lancet 2012; 380: 1749–1758.
  8. Easton JD et al. Lancet Neurol 2012; 11: 503–511.
  9. Garcia DA et al. Am Heart J 2013; 166: 549–558.
  10. Hohnloser SH et al. Eur Heart J 2012; 33: 2821–2830.
  11. Halvorsen S et al. Eur Heart J 2014; 35: 1864–1872.

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Job code: 432UK1900440-01
Date of preparation: September 2019

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