Stephan Moll, MD writes… Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE. The approval covers (a) acute DVT/PE management and (b) the longer-term prevention of recurrent DVT/PE.
- For acute management of VTE: 10 mg taken twice daily for 7 days, followed by 5 mg twice daily.
- For secondary prevention of VTE recurrence: 2.5 mg taken twice daily.
The Clinical Studies
Approval was based on 2 large clinical trials, the AMPLIFY [ref 1] and AMPLIFY-EXTENSION [ref 2] trials. The acute treatment trial (5,244 patients enrolled) showed that apixaban, given immediately upon the diagnosis of new DVT or PE, was as effective as conventional therapy (an injection blood thinner followed by warfarin) and was associated with significantly less major and relevant bleeding. Thus: Apixaban was as effective as warfarin, but safer. In the extension trial 2,486 patients received either apixaban or placebo for 12 months after they had completed 6-12 months of standard blood thinner therapy for DVT or PE. Apixaban reduced the risk of recurrent clots without increasing the rate of major bleeding.
Further Information on Apixaban
- Medication guide for patients (click here)
- Full prescribing information for apixaban (click here)
- The press release from Bristol-Myers-Squibb is here.
Blood Thinner Choices for Treatment of DVT and PE
Three new oral blood thinners (also referred to as NOACs) are now FDA-approved and available for the treatment of DVT and PE. A fourth one, edoxaban (Savaysa®), is not available at this time, but is under FDA review. This Clot Connect document provides a summary table of the pros and cons of the NOACs compared to warfarin, and also a table comparing the 3 available NOACs amongst each other. The lower risk of major and clinically relevant non-major bleeding makes Eliquis® an attractive choice; the once daily dosing regimen makes Xarelto® an attractive choice. I do not see any advantage of Pradaxa® over the other two drugs.
- Agnelli G et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013;369:799-808.
- Agnelli G et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013; 368:699-708.
Disclosure: I have in the past consulted for Janssen, Daiichi, Boehringer Ingelheim.
Last updated: Aug 22nd, 2014