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      Prophylactic Factor VIIa Improves Quality of Life for Hemophiliacs: Presented at ASH

      By Ric Susman

      ORLANDO, FL -- December 11, 2006 -- Once daily administration of recombinant human coagulation factor VIIa as secondary prophylaxis against joint bleeding improves the quality of life of patients with hemophilia, researchers reported here at the 48th annual meeting of the American Society of Hematology (ASH).

      "Considerable improvements in a variety of important measures of quality of life were detected along with clinically relevant reductions in the number of bleeds," said Barbara A. Konkle, MD, associate professor of medicine and professor of pathology and laboratory medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.

      "Prior to entry, patients enrolled in this trial bled frequently and overall had significant joint disease," Dr. Konkle said in a poster presentation on December 9th. After 3 months of observation, 11 patients were treated with 90 mcg/kg daily of Factor VIIa and 11 other patients were treated with 270 mcg/kg daily of Factor VIIa.

      For those patients given the 90 mcg/kg dosage the mean age was 13 years (range 5.1-50.5), while those given the 270 mcg/kg dosage had a mean age of 17.8 years (range 10.6-56.1).

      Treatment with either dose of Factor VIIa resulted in reduction of bleeding by 45% to 50% (P < .0001). In addition, Dr. Konkle said the number of days away from school or work was significantly lower in patients treated with Factor VIIa than in those who received conventional on-demand treatment (38.7% vs 16.7% days absent; P = .0127).

      Patients taking recombinant human coagulation factor VIIa reduced their time spent in hospitals from 13.5% of days to 5.9% of days (P = .0026), Dr. Konkle said.

      Dr. Konkle said there were no clinically significant adverse events in the study.

      The study was supported by Novo Nordisk, Bagsvaerd, Denmark.


      [Secondary Prophylaxis with fRVlla Improves Quality of Life of Hemophilia Patients With Inhibitors and Frequent Bleeds. Abstract 1028]



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