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More rivaroxaban Success


[The link has additional news about Factor Xa inhibitors.]

http://genengnews.com/news/bnitem.aspx?name=46696016


>> Once-Daily Oral Rivaroxaban Compared With Subcutaneous Enoxaparin Every 12 Hours for Thromboprophylaxis After Total Knee Replacement: RECORD4 [Abstract #35]
Alexander G.G. Turpie, MD, McMaster University, Hamilton, Ontario, Canada

This study concluded that investigational rivaroxaban, an oral Factor Xa inhibitor, is more efficacious than a current standard of therapy, enoxaparin, for the prevention of venous thromboembolism following total knee replacement surgery without significantly increasing the risk of bleeding. Coupled with previous research that demonstrated that post-operative rivaroxaban was more effective than pre-operative enoxaparin in preventing deep-vein clotting, along with an easier method of administration (oral versus subcutaneous injection), this study may change the way physicians prevent serious blood clots in patients undergoing major orthopedic surgery.

In this study, a total of 3,148 patients were randomized to receive either once-daily oral rivaroxaban (10 mg) starting six to eight hours after surgery or twice-daily subcutaneous injections of enoxaparin beginning 12 to 24 hours after surgery for 10 to 14 days. Patients underwent mandatory, bilateral venography (X-ray of the vein) between days 11 and 15.

The primary endpoint of the study was the combined occurrences of deep-vein thrombosis, non-fatal pulmonary embolism, and all-cause mortality up to day 17. The main safety endpoint was major bleeding observed after one dose of the drug until two days after the end of treatment. Efficacy was determined first by a test for non-inferiority in the per-protocol population of 1,702 patients, followed by a test for superiority in the intention-to-treat population of 1,924 patients.

The results indicated that rivaroxaban significantly reduced the incidence of adverse events (the combination of blood clots and death) by 31 percent as compared with enoxaparin, with no significant increase in the rate of major bleeding events. Rivaroxaban and enoxaparin appeared equally effective at preventing major venous blood clots and pulmonary embolism. <<