This information is intended for healthcare professionals based in Ireland.

AMPLIFY-EXT

AMPLIFY-EXT – a 12- month trial of ELIQUIS® vs. placebo in over 2,000 patients with DVT (Deep Vein Thrombosis) or PE (Pulmonary Embolism) (with or without DVT)1

AMPLIFY-EXT (ELIQUIS® after the initial Management of Pulmonary embolIsm and deep vein thrombosis with First-line therapy-EXTended treatment) was designed to demonstrate the efficacy and safety of ELIQUIS® compared to placebo for the prevention of recurrent DVT and PE following six to 12 months of anticoagulant treatment for DVT and/or PE.1

amplify-ext eliquis (apixaban) trial design image

Baseline Characteristics1

VTE=Venous Thromboembolic Events

Inclusion criteria1

Eligible patients were those aged 18 years or older with objectively confirmed, symptomatic DVT or PE (with or without DVT); patients who had been treated for 6 to 12 months with standard anticoagulant therapy or had completed treatment with ELIQUIS® or enoxaparin/warfarin as participants in the AMPLIFY trial; and patients for whom there was clinical equipoise regarding the continuation or cessation of therapy.

Important exclusion criteria1

Patients were excluded if they had a contraindication to continued anticoagulant therapy or if they required ongoing anticoagulant therapy, dual antiplatelet therapy, or ASA (Acetylsalicylic Acid) at a dose higher than 165 mg daily.

ELIQUIS® was superior to placebo in reducing the recurrence of VTE (Venous Thromboembolic Events), with a comparable incidence of major bleeding1,2

amplify-ext eliquis (apixaban) trial results image

RRR = Relative Risk Reduction
*Only ELIQUIS® 2.5 mg BD is licensed for extended treatment.2

  • ELIQUIS® 2.5 mg demonstrated comparable incidences of bleeding vs. placebo for:
    • Clinically relevant non-major bleeding (3.0% vs. 2.3%)1
    • Major or clinically relevant non-major bleeding (3.2% vs. 2.7%)1

Extended anti coagulation with ELIQUIS® 2.5mg BD (twice daily) reduced the risk of recurrent venous thromboembolism without increasing the rate of major bleeding compared to placebo1

AMPLIFY-EXT: ELIQUIS® after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment.

Patients could have multiple risk factors.1

Data on the use of antiplatelet agents were calculated in the safety population (840 patients in the ELIQUIS® 2.5 mg group, 811 in the ELIQUIS® 5 mg group, and 826 in the placebo group), rather than the ITT (Intention To Treat) population.1

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. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. New Engl J Med 2013;368:699-708.
  2. ELIQUIS® (apixaban) Summary of Product Characteristics.