Early administration of vapreotide for variceal bleeding in patients with cirrhosis

Background: In patients with cirrhosis, pharmacologic or endoscopic treatment may control variceal bleeding. However, the effects of early administration of a somatostatin analogue followed by endoscopic treatment are unknown. Methods: We studied the effects of treatment with vapreotide, a somatostatin analogue, begun before endoscopic treatment in 227 patients with cirrhosis who were hospitalized for acute upper gastrointestinal bleeding. The patients were randomly assigned to receive vapreotide (a 50-mug intravenous bolus followed by an infusion at a rate of 50 mug per hour for five days) or placebo within a mean (+/-SD) of 2.3+/-1.5 hours after admission. The patients received endoscopic treatment a mean of 2.6+/-3.3 hours after the infusion was begun. After the exclusion of 31 patients whose bleeding was not caused 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 patients in the placebo group (46 percent, P = 0.03); in 12 patients endoscopy was either impossible or showed portal hypertensive gastropathy. During the five-day infusion, the primary objective - survival and control of bleeding - 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 blood transfusions (2.0+/-2.2 vs. 2.8+/-2.8 units, P = 0.04). Overall mortality rates at 42 days were not significantly different in the two groups. Conclusions: In patients with cirrhosis and variceal bleeding, the combination of vapreotide and endoscopic treatment is more effective than endoscopic treatment alone as a method of controlling acute bleeding. However, the use of combination therapy does not affect mortality rates at 42 days. (N Engl J Med 2001;344:23-8.) Copyright (C) 2001 Massachusetts Medical Society.