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
* 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.1†Patients 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
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.
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.
RRR = Relative Risk Reduction
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