March 4th, 2010
Thursday, March 4 News: Apixaban Advances
Larry Husten, PHD
Apixaban, a new factor Xa inhibitor under development, was compared with enoxaparin for thromboprophylaxis following knee replacement surgery in the ADVANCE-2 trial. The new report appears in the Lancet. In the primary efficacy analysis, the primary outcome — the composite of asymptomatic and symptomatic deep vein thrombosis, nonfatal pulmonary embolism, and all-cause death during treatment — was reached in 15% of apixaban patients compared with 24% of enoxaparin patients, a highly significant difference. Major or other clinically relevant bleeding was reported in 4% of the apixaban group versus 5% of the enoxaparin group.
In an accompanying comment, Jawed Fareed and Russell Hull note that in the previously published ADVANCE-1 trial, apixaban did not demonstrate noninferiority when compared to a different enoxaparin regimen, although it was associated with a lower bleeding rate. (ADVANCE-2 used the enoxaparin regimen most commonly employed outside the U.S.; ADVANCE-1 used the standard U.S. regimen.) The editorialists write that ADVANCE-2 brings us “potentially a step closer to the unmet need of oral antithrombotic therapy without need for monitoring.” Other new agents, including rivaroxaban and dabigatran, may also fill this need, they say.