FDA approves low-dose rivaroxaban for long-term PE/DVT prevention

The long-term management of recurrent venous thromboembolism continues to evolve with the FDA's approval of once-daily low-dose rivaroxaban, now indicated for patients with recurrent deep venous thrombosis or pulmonary embolism who have completed at least six months of anticoagulation.

FDA approved low-dose rivaroxaban based on data from 3,395 patients in the EINSTEIN-CHOICE study. Both 20 mg and 10 mg daily doses of rivaroxaban appeared equivalent (and better than aspirin) at reducing the risk of recurrent DVT or PE (66% and 74% relative risk reductions, respectively). There was no excess bleeding risk observed.

After initial DVT or PE, rivaroxaban is dosed at 15 mg twice daily in the first 21 days, followed by 20 mg daily until six months after the initial event. Patients who are seen as having elevated risk for recurrent PE/DVT would then take rivaroxaban 10 mg daily for an indefinite period of time under the new FDA indication.

The new approval creates a new therapeutic option for physicians, and a marketing opportunity for Bayer and Janssen, makers of rivaroxaban (Xarelto). Physicians are often uneasy prescribing full-dose anticoagulation long-term, in accordance with professional guidelines, due to bleeding risk. Yet they may be equally uncomfortable discontinuing anticoagulation in patients perceived at elevated risk for recurrent pulmonary embolism. With its apparently low bleeding risk, the new lower dose of rivaroxaban offers a middle ground.

Patients at high risk for recurrent DVT/PET such as those with active cancer or severe thrombophilia were not included in the EINSTEIN-CHOICE study. The relative benefits or risks of a reduced dose of rivaroxaban in such patients are unknown.

Source: FDA