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Clinical Data Suggest Decreased Bleeding Risk in People With Severe,Hemophilia A While Maintaining Factor VIII Levels Above One Percent

Results Highlighted in Oral Presentation at International Symposium of Thrombosis and Haemostasis

GENEVA, July 10, 2007 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation today announced the presentation of findings from the ADAPT (Analysis of Data from ADVATE(R) Prospective Trials) study program database showing a statistically significant relationship between the duration of time spent with factor VIII blood levels below one international unit per deciliter (1 IU/dL, one percent of normal factor VIII level) and an increase in the annual bleed rate in people with hemophilia A. The findings from ADAPT suggest that maintaining trough levels above 1 IU/dL with prophylactic therapy may decrease the number of bleeding episodes, particularly in children.

"Until now there has been insufficient clinical evidence to demonstrate that factor VIII levels less than 1 IU/dL are associated with increased bleeding in patients receiving prophylaxis for the management of hemophilia A," said Peter W. Collins M.D., FRCP, FRCPath, Department of Haematology, University Hospital of Wales, Cardiff, U.K.

"These results suggest that decreasing the amount of time a patient spends with a factor VIII less than 1 IU/dL will reduce the number of bleeds. This can be achieved in part by improving adherence to prescribed prophylaxis, while measurement of trough factor VIII levels in some patients may help individual tailoring of factor VIII dosing regimens."

Dr. Collins presented data from the ADAPT group showing an analysis of 48 children (one to six years of age) and 100 adolescents and adults (10 to 65 years of age) with severe hemophilia A and factor VIII levels less than 1 IU/dL who participated in ADVATE clinical trials. All participants were initially evaluated in a 48-hour pharmacokinetic study to measure their rate of clearance of ADVATE prior to initiation of prophylactic therapy. The 10 to 65 years old grou
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