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Reuters Health Information (2004-11-12): Patients with severe cirrhosis and upper GI bleeding benefit from rFVIIa Clinical
Patients with severe cirrhosis and upper GI bleeding benefit from rFVIIa
Last Updated: 2004-11-12 15:40:11 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In a large European trial
in patients with cirrhosis, addition of recombinant factor VIIa
(rFVIIA) to standard therapies for upper gastrointestinal bleeding did
not significantly improve bleeding endpoints in the overall study
population but did benefit patients with more severe disease.
Dr. Jaime Bosch of Hospital Clinic Provincial in Barcelona, Spain,
and colleagues randomized 245 patients with cirrhosis and upper
gastrointestinal bleeding to receive either 8 doses of 100ug/kg of
recombinant factor VIIa, or placebo, along with standard medications
and endoscopy. The primary endpoint had three components: failure to
control bleeding within 24 hours after the first dose, failure to
prevent rebleeding between 24 hours and day 5, and death within 5 days.
A report of the study, by the 26-center European Study Group on
rFVIIa in Upper Gastrointestinal Hemorrhage, appears in the October
issue of Gastroenterology.
Addition of the coagulation factor provided "no advantage over
standard treatment" in the overall trial population, the researchers
write. But, they added, post hoc analyses on patients stratified by
severity of cirrhosis showed "significant reductions in failure rates
for the composite and 24-hour bleeding control end points then were
observed with rFVIIa treatment in the subgroup of variceal bleeders
with advanced cirrhosis and more severe coagulopathy (Child-Pugh
classes B or C)."
There was no significant difference in mortality or incidence of adverse effects, the authors write.
The fact that treatment was helpful only in patients with moderate
to severe cirrhosis "is consistent with the ability of rFVIIa to
correct coagulopathy," the investigators write. "Further studies are
required to better define the target population that may benefit the
most from rFVIIa treatment to establish the minimal effective dosing
regimen and pharmacoeconomics for this drug."
Gastroenterology 2004;127:1123-1130.
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