Eikelboom - Evidence from the Randomized Trials - Figure 23
AMPLIFY-EXT Design
The third program assessing the NOACs for treatment of VTE has been conducted with the factor Xa inhibitor apixaban. Apixaban has been studied in two trials: AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) was the first trial and assessed 3 to 6 months of treatment with apixaban compared with standard of care. Like the EINSTEIN program, treatment was started upfront (immediately) with apixaban in the experimental group and compared with standard treatment, consisting of LMWH transitioning to warfarin.[13]
In the AMPLIFY-EXT (Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy–Extended Treatment) trial,[14] 2500 patients who had completed 6 months of anticoagulant therapy were randomized to 1 of 3 treatments (Figure 23):
• apixaban 2.5 mg twice daily, which is the prophylactic dose of apixaban;
• apixaban 5 mg twice daily, which is the treatment dose of apixaban and the one used in AMPLIFY;
• placebo.
Eikelboom J. Am J Med 2013; published on-line at http://education.amjmed.com/00000.
References
[13] Agnelli G, Buller HR, Cohen A, et al; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. Published online ahead of print July 1, 2013.
[14] Agnelli G, Büller HR, Cohen A, et al; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368:699-708.