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Rivaroxaban Effective in Preventing Thrombosis

Last Updated: May 05, 2009.

A phase III trial of oral rivaroxaban has shown that it is more effective than subcutaneous enoxaparin in preventing venous thromboembolism after total knee arthroplasty, according to a study published online May 5 in The Lancet.

TUESDAY, May 5 (HealthDay News) -- A phase III trial of oral rivaroxaban has shown that it is more effective than subcutaneous enoxaparin in preventing venous thromboembolism after total knee arthroplasty, according to a study published online May 5 in The Lancet.

Alexander G.G. Turpie, M.D., of McMaster University in Hamilton, Canada, and colleagues conducted the trial comprising 3,148 total knee arthroplasty patients who were randomized to receive either 10 mg a day of oral rivaroxaban starting between six and eight hours after surgery, or 30 mg of enoxaparin every 12 hours starting 12 to 24 hours after surgery.

Of 965 patients given rivaroxaban, 67 (6.9 percent) achieved the primary efficacy outcome, which was a composite of any deep-vein thrombosis, non-fatal pulmonary embolism, or death from any cause within 17 days of surgery, while 97 (10.1 percent) of 959 patients given enoxaparin reached it, the investigators found.

"Rivaroxaban significantly reduced the absolute risk of total venous thromboembolism by 3.2 percent (relative risk reduction, 31 percent)," the authors write. "Although there were more major, major plus clinically relevant non-major, and any bleeding events with rivaroxaban, the differences compared with enoxaparin were not statistically significant."

The study was funded by Bayer Schering Pharma AG and Johnson & Johnson Pharmaceutical Research & Development. Four of the study authors are employees of Bayer Schering Pharma AG and all the other authors reported having served as consultants to Bayer Schering Pharma AG and receiving honoraria as members of the study's steering committee.

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