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.