Stephan Moll, MD writes… Another new oral blood thinner (Eliquis = apixaban) was approved by the FDA on Dec 28th, 2012 – to be used by patients with irregular heart beat (atrial fibrillation) to prevent stroke. The drug is NOT yet FDA-approved for treatment of patients with DVT or PE. Clinical trials evaluating Eliquis for this indication are still ongoing.
How is this approval relevant for patients with DVT or PE? Not directly; it would not be appropriate to use the drug off label in DVT and PE treatment, since no large clinical trial data are available at this point regarding the drug’s effectiveness and safety in patients with DVT and PE. However, any approval of one of the new oral anticoagulants is interesting, as these drugs are – in general – more convenient to take than warfarin: They do not require routine monitoring, have no interactions with vitamin K in the diet, are rapidly fully active within a few hours of taking the first dose, and out of the system within 1-2 days after stopping them.
The 4 big new oral anticoagulants and DVT and PE, i.e. venous thromboembolism (VTE)
- Rivaroxaban: In the U.S., only rivaroxaban (Xarelto) is FDA approved for the treatment of acute DVT and PE and for the longer-term (so-called “secondary”) prevention of recurrent VTE.
- Apixaban: The phase 3 clinical trial of apixaban (Eliquis) in patients with acute VTE is still ongoing (link here) and results are expected in the 2nd part of 2013. The Apixaban secondary prevention trial (AMPLIFY-EXTENSION) was published in the N Engl J Med on Dec 8th, 2012, showing that apixaban, compared to placebo, decreased the risk of recurrent VTE without increasing the rate of major bleeding.
- Dabigatran: The company making Dabigatran (Pradaxa; Boehringer-Ingelheim) does not appear to have applied yet for FDA approval for the VTE indication.
- Edoxaban: The major phase 3 acute VTE treatment trial with the anti-Xa agent edoxaban (Hokusai trial) is still ongoing – it finished enrollment, but follow-up is ongoing. Results are expected in 2013.
- Granger CB et al. Apixaban versus warfarin in patients with atrial fibrillation. NEJM 2011;365:981-92.
- Connolly SJ et al. Apixaban in patients with atrial fibrillation. NEJM 2011;364:806-17.
- Garcia D et al. The new oral anticoagulants. Blood 2010;115:15-20.
Disclosure: I have consulted for Janssen, Boehringer-Ingelheim, and Daiichi.
Last updated: Dec 29th, 2012