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Reuters Health Information (2007-05-25): Factor VIIa cuts mortality in patients with cirrhosis and variceal bleeding


Factor VIIa cuts mortality in patients with cirrhosis and variceal bleeding

Last Updated: 2007-05-25 17:23:11 -0400 (Reuters Health)

WASHINGTON, DC (Reuters Health) - Mortality is significantly decreased when Factor VIIa (FVIIa) is given to patients with advanced cirrhosis and active variceal bleeding, a European team reported here this week at Digestive Disease Week (DDW) 2007.

Dr. Flemming Bendtsen, of Hvidovre Hospital in Denmark, and colleagues randomized 256 patients with cirrhosis and active bleeding from gastro-esophageal varices to FVIIa 600 micrograms/kg or 300 micrograms/kg or placebo. They gave treatment at baseline and 2, 8, 14 and 20 hours later.

Patients all continued with standard treatment with vasoactive agents, prophylactic antibiotics and endoscopic treatment, as needed.

There were 26% patients in Child-Pugh class B, with a one-year mortality rate of 81% and 74% in Child-Pugh class C, with a one-year mortality rate of 45%.

Dr. Bendtsen reported that at 24 hours, FVIIa treatment did not meet the primary endpoint of active bleeding control, with 9% of patients in each of the three arms continuing to bleed.

At five days, uncontrolled bleeding continued in 4% of patients in each active treatment arm and in 9% of patients on placebo.

Five-day mortality was 13%, 12% and 5% of patients on placebo, high- and low-dose treatment, respectively.

However, 42-day mortality was only 15% in high-dose patients compared with 31% of patients on low-dose FVIIa and 29% of patients on placebo.

Dr. Bendtsen told Reuters Health that FVIIa has the potential risk of causing arterial thrombosis, which occurred in three patients, "but this was not a significant increase over placebo," he said. "We would need to combine it with vasoconstrictors to decrease risk of adverse events."

"You need to give several doses to see efficacy and this is a very costly drug," Dr. Bendtsen added. "We would need to offer it to very specific patients, only."

Dr. Bendtsen and his colleagues are conducting subanalyses to determine if there are any specific characteristics that would identify which patients might benefit from FVIIa therapy.

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