This information is intended for healthcare professionals based in Ireland.

Phase III Clinical Trials

Prevention of VTE after elective hip of knee replacement surgery

ADVANCE-2 and ADVANCE-3 trials were multinational trials that together included 8,464 patients undergoing elective knee or hip replacement surgery.1,2

The objective of both studies was to evaluate the efficacy and safety of ELIQUIS® for the prevention of VTE in patients undergoing total knee replacement or total hip replacement surgery.

Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)

A total of 23,800 patients were randomised in the clinical program (ARISTOTLE: ELIQUIS® versus warfarin, AVERROES: ELIQUIS® versus ASA [Acetylsalicylic Acid]) including 11,928 randomised to ELIQUIS®.3,4

The program was designed to demonstrate the efficacy and safety of ELIQUIS® for the prevention of stroke and systemic embolism in patients with non valvular atrial fibrillation (NVAF) and one or more additional 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 DVT and PE, and prevention of recurrent DVT and PE in adults

  • AMPLIFY– a Phase III trial of ELIQUIS® vs. enoxaparin/warfarin in over 5,000 patients with acute VTE.5
  • AMPLIFY-EXT– a 12-month trial of ELIQUIS® vs. placebo in over 2,000 patients with DVT or PE (with or without DVT) who had completed 6-12 months of anticoagulation therapy and for whom there was clinical equipose regarding continuation or cessation of therapy.6

Risk Minimisation Materials

The Eliquis (apixaban) Prescriber Guide and Patient Alert Card are risk minimisation materials developed for all indications as an aid to prescribing, in particular they are aimed at increasing awareness about the potential risk of bleeding during treatment with apixaban and providing guidance on how to manage that risk. Printed copies of these educational materials may be obtained by contacting the Bristol-Myers Squibb Medical Information Department (telephone: 1800 749 749; e-mail: medical.information@bms.com). Alternatively, electronic copies can be accessed via the HPRA website at http://www.hpra.ie/homepage/medicines/medicines-information/find-a-medicine.

References:

  1. Lassen MR, Raskob G, Gallus A, et al. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet 2010;375:807-815.
  2. Lassen MR, Gallus A, Raskob G, et al. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. New Engl J Med 2010;363:2487-2498.
  3. Granger CB, Alexander JH, McMurray JJ. Apixaban versus warfarin in patients with atrial fibrillation. New Engl J Med 2011;365:981-992.
  4. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. New Engl J Med 2011;364:806-817.
  5. Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. New Engl J Med 2013;369:799-808.
  6. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. New Engl J Med 2013;368:699-708.