Rivaroxaban approved for the treatment of DVT and PE

Rivaroxaban approved for the treatment of DVT and PE

In early November 2012, the FDA expanded the approved use of rivaroxaban (brand name Xarelto) to be used for the treatment of blood clots in deep veins (deep venous thrombosis, DVT) and in pulmonary arteries (pulmonary embolism, PE).  Rivaroxaban was originally approved for the treatment of patients with atrial fibrillation. DVT and PE are major health concerns in the United States with about 300,000 patients diagnosed annually.  It is estimated that DVT and PE are the cause of 100,000 deaths per year.

The standard treatment for these conditions in the US has consisted of starting patients on unfractionated heparin or low molecular weight heparin  followed by a Vitamin K antagonist (Coumadin or warfarin). This treatment requires frequent blood monitoring.

Analysis of the Einstein PE trial showed that rivaroxaban, which does not require regular monitoring, is not inferior to the standard treatment.

One word of caution regarding the results: only 5% of patients in the Einstein PE trial had malignancies and clearly more data are needed before rivaroxaban can be uniformly recommended for patients with cancer and DVT/PE.