This information is intended for healthcare professionals based in Ireland.

AMPLIFY

AMPLIFY- a Phase lll trial of ELIQUIS® vs. enoxaparin/warfarin in over 5,000 patients with acute VTE (Venous Thromboembolic Events)1

AMPLIFY (ELIQUIS® After the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-line Therapy) was designed to demonstrate the efficacy and safety of ELIQUIS® for the treatment of DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) versus standard of care (initial enoxaparin for at least five days overlapped by warfarin therapy [target International Normalized Ratio (INR) range 2.0-3.0] orally for six months).1

amplify eliquis (apixaban) trial design image

* Patients assigned to the ELIQUIS® group received ELIQUIS® 10 mg BD for the first 7 days, followed by ELIQUIS® 5 mg BD for 6 months.1Patients assigned to the conventional-therapy group received enoxaparin at a dose of 1 mg per kilogram of body weight every 12 hours for at least 5 days and warfarin begun concomitantly and continued for 6 months. The warfarin dose was adjusted to maintain the INR between 2.0 and 3.0. Enoxaparin or placebo was discontinued when a blinded INR of 2.0 or more was achieved.1

Baseline Characteristics1

Inclusion criteria1

Eligible patients were those aged 18 years or older with objectively confirmed, symptomatic proximal DVT, or PE (with or without DVT). Proximal DVT was defined as thrombosis involving at least the popliteal vein or a more proximal vein.

Important exclusion criteria1

Patients were excluded if they had active bleeding, a high risk of bleeding, or other contraindications to treatment with enoxaparin and warfarin; cancer and planned long-term treatment with LMWH (Low-Molecular-Weight Heparin); if DVT or PE was provoked in the absence of a persistent risk factor for recurrence; if less than 6 months of anticoagulant treatment was planned; or if they had another indication for long-term anticoagulation therapy, dual antiplatelet therapy, treatment with ASA (Acetylsalicylic Acid) at a dose of more than 165 mg daily, or treatment with potent inhibitors of cytochrome P-450 3A4.

ELIQUIS® demonstrated efficacy comparable to enoxaparin/warfarin, with a significant 69% relative risk reduction in major bleeding1

AMPLIFY Efficacy Results

amplify eliquis (apixaban) trial efficacy results image

RRR = Relative Risk Reduction

  • The efficacy of ELIQUIS® vs. enoxaparin/warfarin was maintained regardless of whether the index event was a DVT or a PE (p-value for Interaction=0.82)1*

In AMPLIFY, ELIQUIS® 10 mg BD (Twice Daily); for 7 days followed by ELIQUIS® 5 mg BD for 6 months demonstrated comparable efficacy to conventional treatment consisting of enoxaparin followed by warfarin and was associated with reduced risk of major bleeding.1

*In patients with PE (with or without DVT), 21 events were reported in the ELIQUIS® group vs. 23 events in the enoxaparin/warfarin group. In patients with DVT only, 38 events were reported in the ELIQUIS® group vs. 47 events in the enoxaparin/warfarin group.2

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. Oral apixaban for the treatment of acute venous thromboembolism. New Engl J Med 2013;369:799-808.
  2. ELIQUIS® (apixaban) Summary of Product Characteristics.