Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: a randomized, double-blind trial. Export

@article{citeulike:2873520, abstract = {BACKGROUND \& AIMS: Upper gastrointestinal bleeding (UGIB) is a severe and frequent complication of cirrhosis. Recombinant coagulation factor VIIa (rFVIIa) has been shown to correct the prolonged prothrombin time in patients with cirrhosis and UGIB. This trial aimed to determine efficacy and safety of rFVIIa in cirrhotic patients with variceal and nonvariceal UGIB. METHODS: A total of 245 cirrhotic patients (Child-Pugh < 13; Child-Pugh A = 20\%, B = 52\%, C = 28\%) with UGIB (variceal = 66\%, nonvariceal = 29\%, bleeding source unknown = 5\%) were randomized equally to receive 8 doses of 100 microg/kg rFVIIa or placebo in addition to pharmacologic and endoscopic treatment. The primary end point was a composite including: (1) failure to control UGIB within 24 hours after first dose, or (2) failure to prevent rebleeding between 24 hours and day 5, or (3) death within 5 days. RESULTS: Baseline characteristics were similar between rFVIIa and placebo groups. rFVIIa showed no advantage over standard treatment in the whole trial population. Exploratory analyses, however, showed that rFVIIa significantly decreased the number of failures on the composite end point (P = 0.03) and the 24-hour bleeding control end point (P = 0.01) in the subgroup of Child-Pugh B and C variceal bleeders. There were no significant differences between rFVIIa and placebo groups in mortality (5- or 42-day) or incidence of adverse events including thromboembolic events. CONCLUSIONS: Although no overall effect of rFVIIa was observed, exploratory analyses in Child-Pugh B and C cirrhotic patients indicated that administration of rFVIIa significantly decreased the proportion of patients who failed to control variceal bleeding. Dosing with rFVIIa appeared safe. Further studies are needed to verify these findings.}, address = {Hospital Clinic, Liver Unit, Barcelona, Spain. jbosch@medicina.ub.es}, author = {Bosch, J. and Thabut, D. and Bendtsen, F. and D'Amico, G. and Albillos, A. and Gonz\'{a}lez Abraldes, J. and Fabricius, S. and Erhardtsen, E. and de Franchis, R. and {}}, citeulike-article-id = {2873520}, citeulike-linkout-0 = {http://view.ncbi.nlm.nih.gov/pubmed/15480990}, citeulike-linkout-1 = {http://www.hubmed.org/display.cgi?uids=15480990}, issn = {0016-5085}, journal = {Gastroenterology}, keywords = {10, 4, cirrhosis, coagulopathy, gi, haemorrhage, rfviia}, month = {October}, number = {4}, pages = {1123--1130}, posted-at = {2008-06-08 15:09:59}, priority = {2}, title = {Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: a randomized, double-blind trial.}, url = {http://view.ncbi.nlm.nih.gov/pubmed/15480990}, volume = {127}, year = {2004} }

TY - JOUR ID - citeulike:2873520 L3 - citeulike-article-id:2873520 N2 - BACKGROUND & AIMS: Upper gastrointestinal bleeding (UGIB) is a severe and frequent complication of cirrhosis. Recombinant coagulation factor VIIa (rFVIIa) has been shown to correct the prolonged prothrombin time in patients with cirrhosis and UGIB. This trial aimed to determine efficacy and safety of rFVIIa in cirrhotic patients with variceal and nonvariceal UGIB. METHODS: A total of 245 cirrhotic patients (Child-Pugh < 13; Child-Pugh A = 20%, B = 52%, C = 28%) with UGIB (variceal = 66%, nonvariceal = 29%, bleeding source unknown = 5%) were randomized equally to receive 8 doses of 100 microg/kg rFVIIa or placebo in addition to pharmacologic and endoscopic treatment. The primary end point was a composite including: (1) failure to control UGIB within 24 hours after first dose, or (2) failure to prevent rebleeding between 24 hours and day 5, or (3) death within 5 days. RESULTS: Baseline characteristics were similar between rFVIIa and placebo groups. rFVIIa showed no advantage over standard treatment in the whole trial population. Exploratory analyses, however, showed that rFVIIa significantly decreased the number of failures on the composite end point (P = 0.03) and the 24-hour bleeding control end point (P = 0.01) in the subgroup of Child-Pugh B and C variceal bleeders. There were no significant differences between rFVIIa and placebo groups in mortality (5- or 42-day) or incidence of adverse events including thromboembolic events. CONCLUSIONS: Although no overall effect of rFVIIa was observed, exploratory analyses in Child-Pugh B and C cirrhotic patients indicated that administration of rFVIIa significantly decreased the proportion of patients who failed to control variceal bleeding. Dosing with rFVIIa appeared safe. Further studies are needed to verify these findings. IS - 4 JF - Gastroenterology SN - 0016-5085 AD - Hospital Clinic, Liver Unit, Barcelona, Spain. jbosch@medicina.ub.es EP - 1130 TI - Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: a randomized, double-blind trial. VL - 127 SP - 1123 KW - 10 KW - 4 KW - cirrhosis KW - coagulopathy KW - gi KW - haemorrhage KW - rfviia AU - Bosch, J AU - Thabut, D AU - Bendtsen, F AU - D'Amico, G AU - Albillos, A AU - González Abraldes, J AU - Fabricius, S AU - Erhardtsen, E AU - de Franchis, R PY - 2004/10// UR - http://view.ncbi.nlm.nih.gov/pubmed/15480990 ER -