Education Blog for Healthcare Professionals

Xarelto and DVT – Approved in Europe

Xarelto (Rivaroxaban) was approved in Europe today (Dec 19th, 2011) for patients with acute DVT. This is good news on the path to have a blood thinner for patients with DVT available that is easier to deal with than Warfarin. Xarelto is not approved at this point for DVT and PE treatment in the U.S.  Final evaluation of the recently completed EINSTEIN PE trial is pending.  Today’s European approval announcement can be found here.

 

Personal Comment

Would I prescribe Xarelto off label for patients with DVT and PE, even though it is not yet FDA approved for that indication?  I do not rush into it, but prefer to wait to see what FDA decides on the DVT and PE indication, after review of all the DVT and PE data.  However, if a patient poorly tolerates warfarin, has very fluctuating INRs, has a strong preference to switch away from warfarin, I would discuss  a switch to one of the new oral anticoagualnts, Pradaxa or Xarelto, even now.  And,  if the patient is fully educated, understands that we would be using the drug in a non-FDA approved indication, and still wants to change, I would consider prescribing it for DVT and/or PE.  However, my general preference would be to see clinical experience with the drug gained in the approved indication, before I would use it off label.  

Last updated: Dec 19th, 2011 

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4 Responses to “Xarelto and DVT – Approved in Europe”

    • Stephan Moll says:

      I would expect to see an FDA decision for or against approval within the first half of 2012, but I do not have any insider knowledge, so I don’t know rally know.

      Noteworthy is: The large RECOVER I trial in the past had shown that Dabigatran and warfarin taken for 6 months for acute VTE were equally effective in preventing recurrent VTE and were equally safe [Schulman S et al, NEJM 2009]. The FDA had mandated a follow-up study before considering approval of the drug. The RECOVER II trial now presented was a replica study; a large phase 3 randomized double-blind trial of patients with acute VTE. As in RECOVER I, Dabigatran was not given right off the bat, but only after 5 to 11 days of LMWH or heparin therapy. Dabigatran dose: 150 mg twice daily; length of treatment: 6 months. 2.4 % of 1,279 patients randomized to Dabigatran had a recurrent symptomatic VTE, compared with 2.2 % in the warfarin arm. Conclusions: (a) Dabigatran and warfarin were equally effective, and (b) there was no difference in major bleeding between the two groups.

    • Stephan Moll says:

      One DOES NOT need to overlap – and one SHOULD NOT overlap with LMWH, as otherwise the patient would have two fully active blood thinners on board. In the RECOVER trials tratment in the first up to 11 days was with LMWH alone. The investigators who designed the trial did not dare to use a new oral blood thinner, i.e. the Dabigatran, right off the bat, as they feared that in the acute setting it would not be as effective as the time-proven LMHW. That’s why they gave patients in the first up to 11 days LMMWH rather than Dabigatran.