Columbia study finds hemophilia therapy dramatically improves outcomes for bleed...( 4 hours. Clinical outcomes were assesse...),Health

• After dosing, the size of bleeding in the brain was assessed via CT scan within the first day and again three days later. Results found that overall, rFVIIa-treated patients had approximately half the amount of additional bleeding in the brain compared to placebo-treated patients.
• ICH volume growth in the 40, 80, and 160 g/kg treatment groups (P=0.01, rFVIIa vs. placebo) was reduced by 45%, 52% and 62% compared to the placebo treatment group.
• After 90 days, results found a 38% reduction in mortality and up to three times as many patients surviving with no major neurological deficits, compared to placebo.
• The proportion of patients treated with the 160 g/kg dose of rFVIIa with no disability was 24%, compared to 8% in placebo.
• Also after 90 days, there was a 16% absolute reduction in cases of death or severe disability among the rFVIIa treated patients.
• This indicates that for approximately every six patients treated, one case of death or severe disability was avoided.
• Safety endpoint: The overall frequency of fatal or disabling thromboembolic serious adverse events did not differ between the rFVIIa (2%) and the placebo (2%) groups. However, arterial thromboembolic serious adverse events occurred statistically significantly more frequently with rFVIIa treatment (5%) than with placebo (0%), manifesting in the form of myocardial ischemic events and cerebral infarction. The majority of patients recovered from these complications.

Columbia University Medical Center's Department of Neurology is one of the largest in the country, and is internationally recognized for pioneering research in the development of new treatment modalities and protocols for stroke. Columbia researchers recently won a highly competitive $12 million stroke center grant from the NIH. Columbia is the first site in the eastern United States to r
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Contact: Elizabeth Streich
eas2125@columbia.edu
212-305-6535
Columbia University Medical Center
23-Feb-2005