Eliquis (Apixaban) is one of the 4 promising new oral “blood thinners” that (a) do not require monitoring of its “blood thinning” (anticoagulant) effect, i.e. do not require INR monitoring, and (b) do not interfere with vitamin K in the diet, i.e. patients can eat what they want. It is not available in the US at this point for any indication. The other 3 big drugs in this field are Pradaxa (=Dabigatran), Xarelto (= Rivaroxaban, and Savaysa (=Edoxaban).
The Good News
Good news on Aug 28th: The large atrial fibrillation trial – ARISTOTLE – was published today in the New England Journal of Medicine. A newer Clot Connect blog entry (link here) discusses these developments.
DVT and PE
What does this mean for the patient with DVT and PE? The two major trials that investigate Eliquis in the treatment of DVT and PE are presently still ongoing:
- AMPLIFY study (ClinicalTrials.gov identifier: NCT00643201): This study is ongoing and enrolling several thousand patients with acute DVT or PE. Patients either receive traditional treatment (low molecular weight heparin injections 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 gets enrolled into this “extension” trial and either receives Apixaban or placebo, given for 12 months. In medical terms this is called a secondary prevention trial. Completion of the study is anticipated by April 2013.
So, development of this promising drug is nicely moving forward. But the drug is still a few months away from potentially coming onto the market for patients with atrial fibrillation; and how Eliquis performs in patients with DVT and PE is still being investigated.
Disclosure: I have no financial conflict of interest relevant to this educational post.
Last updated: Aug 28th, 2011
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