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CSL Behring Data Shows 4-Factor Prothrombin Complex Concentrate Is As Effective and a More Rapid Treatment for Vitamin K Antagonist Reversal Than Current Standard of Care
Date:5/4/2012

CHICAGO, May 4, 2012 /PRNewswire/ -- Data presented today by CSL Behring at the 2012 Thrombosis and Hemostasis Summit of North America (THSNA) showed that a balanced, human 4-factor prothrombin complex concentrate (PCC) is as effective as the current standard of treatment in stopping bleeding in patients receiving vitamin K antagonist therapy (i.e., warfarin). Currently in the United States, fresh frozen plasma is the standard treatment for warfarin reversal. The data are from the first and largest randomized clinical study to demonstrate the non-inferiority of 4-factor PCC to plasma through clinical endpoints and to show superiority through bioanalytical endpoints.  

The Phase IIIb study results showed that the hemostatic efficacy of 4-factor PCC was comparable to plasma at 24 hours in patients who required urgent reversal of warfarin therapy (72.4 percent and 65.4 percent, respectively). Additionally, the co-primary efficacy endpoint analysis showed that the 4-factor PCC was superior in achieving target INR correction within 30 minutes at the end of infusion as compared to plasma (62.2 percent and 9.6 percent, respectively). Four-factor PCC was also superior to plasma in rapidly and safely raising the levels of clotting factors II, VII, IX, X, and anticoagulant Proteins C and S at the same 30 minutes post-treatment time point (p values<0.0001).

"Patients on warfarin therapy are susceptible to acute and serious bleeding. For the physician, quickly stopping that bleeding is absolutely critical," said Ravindra Sarode, M.D., Director of Transfusion Medicine and Hemostasis Reference Laboratory at the University of Texas, Southwestern Medical Center, who presented the data. "This trial demonstrates that 4-factor PCC may offer healthcare professionals an important new treatment advance over plasma in managing patient outcomes in an important critical care setting."

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