Extending anticoagulation with apixaban 2.5 or 5 mg cuts risk without increasing major bleeding
MONDAY, Dec. 10 (HealthDay News) -- For patients with venous thromboembolism (VTE) who have completed six to 12 months of anticoagulation therapy, extending anticoagulation with the oral factor Xa inhibitor apixaban is associated with a reduced risk of recurrent VTE, according to a study published online Dec. 8 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Society of Hematology, held from Dec. 8 to 11 in Atlanta.
Giancarlo Agnelli, M.D., from the University of Perugia in Italy, and colleagues compared 2.5 mg and 5 mg of apixaban with placebo for 2,482 patients with VTE who had completed six to 12 months of anticoagulation therapy and for whom there was uncertainty regarding continuation or cessation of anticoagulants.
After 12 months of administration of the study drug, the researchers found that 8.8 percent of patients receiving placebo had symptomatic recurrent VTE or death from VTE, compared with 1.7 percent of patients in the 2.5- and 5-mg apixaban groups (P < 0.001 for both comparisons). The rate of major bleeding was 0.5 percent in the placebo group, compared with 0.2 and 0.1 percent in the 2.5- and 5-mg apixaban groups, respectively. The rates of clinically relevant non-major bleeding were 2.3 percent in the placebo group, compared with 3.0 and 4.2 percent in the 2.5-mg and 5-mg apixaban groups, respectively. The rate of any-cause death was 1.7, 0.8, and 0.5 percent in the placebo, 2.5-, and 5-mg groups, respectively.
"Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism without increasing the rate of major bleeding," the authors write.
The study was funded by Bristol-Myers Squibb and Pfizer; several authors disclosed financial ties to these and other pharmaceutical companies.
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