ISTH: Apixaban Non-Inferior to Conventional Treatment for VTE
No significant difference in relative risk of recurrent VTE; less bleeding with apixaban
MONDAY, July 1 (HealthDay News) -- For patients with venous thromboembolism, treatment with oral apixaban is non-inferior to conventional therapy for preventing recurrent venous thromboembolism or death related to venous thromboembolism, according to a study published online July 1 in the New England Journal of Medicine to coincide with presentation at the annual Congress of the International Society on Thrombosis and Haemostasis, held from June 29 to July 4 in Amsterdam.
Giancarlo Agnelli, M.D., from the University of Perugia in Italy, and colleagues conducted a randomized double-blind study to compare apixaban with subcutaneous enoxaparin, followed by warfarin (conventional therapy) in 5,395 patients with acute venous thromboembolism.
The researchers found that the primary efficacy outcome of recurrent symptomatic venous thromboembolism or death related to venous thromboembolism occurred in 2.3 and 2.7 percent of patients in the apixaban and conventional-therapy groups, respectively (relative risk, 0.84; 95 percent confidence interval, 0.60 to 1.18; difference in risk, −0.4 percentage points; 95 percent confidence interval, −1.3 to 0.4). For predefined upper limits of the 95 percent confidence intervals for both relative risk and difference in risk, apixaban was non-inferior to conventional therapy. Major bleeding occurred in significantly fewer patients in the apixaban group (0.6 versus 1.8 percent; relative risk, 0.31). The composite outcome of major bleeding and clinically relevant non-major bleeding occurred in significantly fewer patients in the apixaban group (4.3 versus 9.7 percent; relative risk, 0.44).
"A fixed-dose regimen of apixaban alone was non-inferior to conventional therapy for the treatment of acute venous thromboembolism and was associated with significantly less bleeding," the authors write.
The study was funded by Pfizer and Bristol-Myers Squibb, the manufacturers of apixaban.
Abstract (http://www.nejm.org/doi/full/10.1056/NEJMoa1302507?query=featured_home#t=abstract )Full Text (http://www.nejm.org/doi/full/10.1056/NEJMoa1302507?query=featured_home#t=article )Editorial (http://www.nejm.org/doi/full/10.1056/NEJMe1307413?query=featured_home )More Information (http://www.isth2013.org )