FDA approves rivaroxaban for prevention of deep-vein thrombosis in surgery.

摘要

Rivaroxaban has just become the first factor Xa inhibitor and so far the only oral anticoagulant to be approved in the United States for orthopaedic surgery. The press release issued by Bayer/ Johnson and Johnson notes that the FDA approval is based entirely on rivaroxaban's performance in the three RECORD trials: 1, 2 and 3, suggesting that no further data were submitted to the FDA. The data from the RECORD trials showed significantly greater efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin and when comparing extended-duration (five weeks) of rivaroxaban with short-duration enoxaparin (two weeks), followed by placebo. In these trials, rivaroxaban and enoxaparin demonstrated similar safety profiles, including low rates of major bleeding.