Apixaban, a Factor Xa Inhibitor, Fails Against Enoxaparin in VTE Study

August 27, 2008

August 27, 2008 (New York, NY) — Results from a study testing the novel anticoagulant apixaban, an oral factor Xa inhibitor, for the prevention of venous thromboembolism (VTE) showed that the drug missed its primary end point in patients undergoing knee surgery, failing to meet statistical criteria for noninferiority when compared with enoxaparin [1].

Bristol-Myers Squibb and Pfizer, the companies that license and market apixaban together, released the results of the study yesterday. In ADVANCE-1, as the trial is called, investigators tested whether apixaban was statistically noninferior to enoxaparin for the prevention of asymptomatic deep vein thrombosis (DVT), pulmonary embolism, and death by any cause in 3195 patients undergoing knee-replacement surgery.

Full results of the ADVANCE-1 study will likely be presented at the American Society of Hematology Meeting this December in San Francisco, CA.

Bristol-Myers Squibb and Pfizer won't apply to the Food and Drug Administration in 2009 to get apixaban approved for the prevention of VTE and are considering further studies with the drug in VTE.

More data on apixaban is expected next week at the European Society of Cardiology 2008 Congress when the APPRAISE-1 investigators present phase 2 data on the use of the anticoagulant in combination with antiplatelet therapy in patients with acute coronary syndrome.

  1. Bristol-Myers Squibb and Pfizer. Bristol-Myers Squibb and Pfizer provide update on apixaban clinical development program [press release]. August 26, 2008. Available at: www.pfizer.com.

face="Verdana" size="1">The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.


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