Bristol-Myers Squibb Company and Pfizer Inc. announced that the ADVANCE-3 study results, published in The New England Journal of Medicine, showed apixaban was statistically superior to 40 mg once daily enoxaparin in reducing the incidence of venous thromboembolism in patients undergoing elective total hip replacement surgery. The study results also showed comparable rates of the composite of major and clinically relevant non-major bleeding, including surgical site bleeding, in patients treated with apixaban compared with those treated with enoxaparin.
Patients undergoing major orthopedic surgery, including total hip replacement, are at high risk for venous thromboembolism. In fact, venous thromboembolism occurs in 40 percent to 60 percent of patients undergoing orthopedic surgery who do not receive preventive care. With close to 200,000 hip replacement surgeries performed each year in the United States, the threat of venous thromboembolism and its associated morbidity and mortality risk represent a growing challenge to physicians.
Apixaban is an investigational, oral, highly selective Factor Xa inhibitor, part of a class of agents being studied for their potential to prevent and treat blood clots in the veins and arteries. Results of ADVANCE-3 were first presented in July 2010, at the 21st International Congress on Thrombosis in Milan, Italy.
“One of the major concerns for orthopedic surgeons using oral anticoagulants for venous thromboembolism prevention in hip surgery is the significant risk of bleeding,” said Michael Rud Lassen, M.D., Hoersholm Hospital in Copenhagen, Denmark, lead investigator for the study. “We are encouraged by the ADVANCE-3 data, which demonstrated that apixaban provides more effective thromboprophylaxis without an increased risk of bleeding, when compared with enoxaparin, and has the advantages of oral administration, which is particularly beneficial once patients leave the hospital.”
Date: December 22, 2010
Source: Bristol-Myers Squibb Company