Eliquis (Apixaban) is one of the 4 promising new oral anticoagulants that (a) do not require routine monitoring of its anticoagulant effect and (b) work independently of the vitamin K pathway. It is not FDA approved or available in the US at this point for any indication. The other 3 big drugs in this field are Pradaxa (Dabigatran), Xarelto (Rivaroxaban), and Lixiana (Edoxaban). At this time, only (a) Pradaxa – for the atrial fibrillation, and (b) Xarelto – for VTE prevention after orthopedic surgery – are FDA approved.
The Good News
Good news on Aug 28th, 2011: Data from the large ARISTOTLE trial were published in the NEJM, showing that in patients with atrial fibrillation Apixaban was more effective in preventing stroke and systemic thromboembolism, caused less major bleeding, and resulted in lower mortality than warfarin in patients with non valvular atrial fibrillation. This is good news. The findings are discussed more in detail and put into perspective in relationship to the other new oral anticoagulants in development and its relevance for DVT/PE in a new Clot Connect post (link here).
DVT and PE
What does this mean for the patient with DVT and PE? The two major trials investigating Apixaban in the treatment of DVT and PE are presently still ongoing:
- AMPLIFY study (ClinicalTrials.gov identifier: NCT00643201): This study is onging and enrolling several thousand patients with acute DVT or PE. Patients either receive traditional treatment (low molecular weight heparin followed by warfarin) or Eliquis (Apixaban) for 6 months. Completion of the study is anticipated by Dec 2012.
- AMPLIFY-EXT study (ClinicalTrials.gov identifier: NCT00633893): Once a patient has completed the regular/traditional several months’ treatment for an episode of DVT or PE, the patient is enrolled into this extension (=secondary prevention) trial and either receives Apixaban or placebo, given for 12 months. Completion of the study is anticipated by April 2013.
Disclosure: I have no financial conflict of interest relevant to this educational post.
Last updated: August 28th, 2011
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Clot Connect 
2 responses to “Apixaban (Eliquis): Good News”
Your good news mentions only one of the secondary endpoints, superiority on bleeding, but not the second, superiority on efficacy…
“In addition, ELIQUIS met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Haemostasis) major bleeding compared to warfarin.”
Any excitement around this for you and your patients?
Thank you for your comment. While it is nice to read that Apixaban was more effective in this trial than warfarin, there is, to be honest, not much “excitement” by me as a clinician about the superiority in the secondary endpoints. Why not? I am afraid that the new oral anticoagulant agents, because they are short-acting, might perform less well than warfarin in real life where non-compliance is so prevalent. So, the superiority shown in the trial may avoid inferiority in real life and lead to equal effectiveness. I think the major attractiveness of the new oral anticoagulants for patients and health care professionals is not that they (or some of them) may be more effective than warfarin in clinical trials, but that (a) their anticoagulant effect does not need to be routinely monitored, (b) that patients can eat what they want, and (c) that they can be discontinued relatively shortly before procedures and restarted shortly thereafter without the need of s.c. bridging with other anticoagulants. What do you think? To be more complete, I have now added a comment on the secondary study endpoint into the main blog.