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Xarelto (Rivaroxaban) – FDA Approved

Today the FDA approved the oral anticoagulant Xarelto (rivaroxaban) for DVT prevention in patients undergoing knee or hip replacement surgery.  This is good news, as Xarelto has been shown to be effective in preventing DVT and PE  and, as an oral drug that does not need routine monitoring of its anticoagulant effect, is easy to take.   In the four pivotal clinical phase 3 Rivaroxaban development trials (called RECORD trials), Xarelto (10 mg once daily) was found to be more effective in preventing DVTs and PEs than Enoxaparin[ref 1]:  in comparison to Enoxaparin it reduced the composite of symptomatic venous thromboembolism and all-cause mortality after elective total hip and total knee replacement surgery. The risk for major bleeding was the same in the Rivaroxaban and Enoxaparin treated patients (o.3 % versus 0.2 %; p=0.23) [ref 1].

As the risk for venous thromboembolism persists for several weeks after major orthopedic surgery and injections with LMWH or Fondaparinux (Arixtra) for several weeks can be cumbersome for the patient to take, it is nice to now have an effective oral alternative available.

The FDA announcement can be found here. The Xarelto prescribing information (package insert) from Bayer/Johnson & Johnson can be found here.

Other Key Studies on Xarelto

Xarelto is NOT approved at this point for treatment of DVT, PE or  for atrial fibrillation. For a Clot Connect discussion of the DVT and PE treatment studies – called the EINSTEIN program – and their publication [ref 2] see here.

Professional Guidelines

Understandably, neither of these 2 major guidelines take reference to the new oral anticoagulants, as the latest editions of both were published in 2008.

  1. American College of Chest Physicians (ACCP):  [Geerts WH et al. Chest 2008;133:381S-453S] – link here.  New ones are expected to come out at the beginning of 2012.
  2. American Academy of Orthopedic Surgeons (AAOS): Clinical Guideline; Aug 2008 – link here.

Reference

  1. Turpie AG et al. Rivaroxaban for the prevention of venous thromboembolism after hip and knee arthroplasty. Pooled analysis of four studies. Thromb Haemost, 2011;105:444-453.
  2. EINSTEIN investigators. Oral Rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-2510.

Disclosures: I have consulted for OthoMcNeil and Bayer, the companies developing Xarelto.

Last updated: July 5th, 2011

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4 Responses to “Xarelto (Rivaroxaban) – FDA Approved”

  1. Chris says:

    Given that it is a non-reversible agent, I presume it is not yet being used for VTE prophylaxis after hip fracture?

    • Stephan Moll says:

      A few comments to possibly clarify and answer: (a) Pharmacodynamically speaking it would be correct to state that Dabigatran is a REVERSIBLE thrombin inhibitor, as it does not bind irreversibly to thrombin; (b) there is no reversal agent or established reversal strategy in case of major bleeding in patients treated with Pradaxa; (c) Pradaxa is, at this point, NOT FDA approved for VTE prophylaxis after hip fracture, so its use in this indication – while doable – would not follow FDA indications. Whether the fear of major bleeding and the lack of a reversal agent or established reversal strategy is enough to not use the agent in whatever FDA-approved or non-approved indication, is up to each physician and patient. These issues are discussed in various other parts of the Pradaxa-associated blogs and comments on Clot Connect, including the next comment below.

  2. Elise C. Brown, MD, MPH says:

    While I agree it is good to have options, I’m wondering if the “good news” is a bit premature. Will there be comments about the lack of any reversal agent, or risk of bleeding?

    • Stephan Moll says:

      1. In the Rivaroxaban DVT prevention program (RECORD program) Rivaroxaban 10 mg qd was more effective than the standard therapy with Enoxaparin in regards to the combined endpoint of symptomatic venous thromboembolism and mortality, yet equally safe in regards to major bleeding. For me, that is clearly good news: more effective yet equally safe as standard therapy, PLUS the convenience of oral rather than s.c. dosing.

      2. Regarding the lack of a reversal agent or established reversal strategy: This clearly needs to be addressed, particularly for the (not yet FDA approved) full dose rivaroxaban regimens used in the VTE treatment trials (15 mg bid for 3 weeks, then 20 mg qd) and in the atrial fibrillation trial (20 mg qd). I think it is less of an issue with the now FDA approved dose (10 mg once daily) used for VTE prevention, given that (a) it is a lower dose, (b) the drug is only used short-term for these indication, and (c) the risk of major bleeding is relatively low with this dose (0.3 % in the RECORD VTE prevention trials). Nevertheless, I am a strong proponent of having peer-reviewed publications on management of major bleeding with all the new oral anticoagulants agents.