Early administration of vapreotide for variceal bleeding in patients with cirrhosis

Background: In patients with cirrhosis, pharmacologic or endoscopic treatme nt may control variceal bleeding. However, the effects of early administrat ion of a somatostatin analogue followed by endoscopic treatment are unknown . Methods: We studied the effects of treatment with vapreotide, a somatostati n analogue, begun before endoscopic treatment in 227 patients with cirrhosi s who were hospitalized for acute upper gastrointestinal bleeding. The pati ents were randomly assigned to receive vapreotide (a 50-mug intravenous bol us followed by an infusion at a rate of 50 mug per hour for five days) or p lacebo within a mean (+/-SD) of 2.3+/-1.5 hours after admission. The patien ts received endoscopic treatment a mean of 2.6+/-3.3 hours after the infusi on was begun. After the exclusion of 31 patients whose bleeding was not cau sed by portal hypertension, there were 98 patients in each group. Results: At the time of endoscopy, active bleeding was evident in 28 of 91 patients in the vapreotide group (31 percent), as compared with 43 of 93 pa tients in the placebo group (46 percent, P = 0.03); in 12 patients endoscop y was either impossible or showed portal hypertensive gastropathy. During t he five-day infusion, the primary objective - survival and control of bleed ing - was achieved in 65 of 98 patients in the vapreotide group (66 percent ) as compared with 49 of 98 patients in the placebo group (50 percent) (P = 0.02). The patients in the vapreotide group received significantly fewer b lood transfusions (2.0+/-2.2 vs. 2.8+/-2.8 units, P = 0.04). Overall mortal ity rates at 42 days were not significantly different in the two groups. Conclusions: In patients with cirrhosis and variceal bleeding, the combinat ion of vapreotide and endoscopic treatment is more effective than endoscopi c treatment alone as a method of controlling acute bleeding. However, the u se of combination therapy does not affect mortality rates at 42 days. (N En gl J Med 2001;344:23-8.) Copyright (C) 2001 Massachusetts Medical Society.