Apixaban, an oral anticoagulant being developed by Bristol-Myers Squibb and Pfizer, was statistically superior to Sanofi-Aventis' Lovenox (enoxaparin) in reducing the incidence of venous thromboembolism in patients undergoing elective total knee replacement surgery, according to study results published in The Lancet.
The ADVANCE-2 study evaluated the efficacy and safety of apixaban compared with subcutaneous Lovenox for reducing the risk of venous thromboembolism in patients undergoing elective total knee replacement surgery. When apixaban was compared with enoxaparin, the primary efficacy endpoint occurred in 15.1 percent of patients in the apixaban group and 24.4 percent of patients in the enoxaparin group, demonstrating a statistically significant relative risk reduction for apixaban of 38 percent.
"One of the major concerns for orthopedic surgeons using oral anticoagulants for venous thromboembolism prevention in knee surgery is the significant risk of bleeding," says Michael Rud Lassen, of the Hoersholm Hospital in Copenhagen, Denmark and lead investigator for the study. "We are encouraged by the ADVANCE-2 data, which demonstrated better antithrombotic effect and comparable bleeding rates for apixaban compared with enoxaparin."
Apixaban is one of a number of new oral anticoagulants, including Boehringer Ingelheim's Pradaxa and Xarelto from Bayer and Johnson & Johnson, hoping to compete against Lovenox, according to Reuters.