Early administration of vapreotide for variceal bleeding in patients with cirrhosis.

Abstract

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-microg intravenous bolus followed by an infusion at a rate of 50 microg per hour for five days) or placebo within a mean (+/-SD) of 2.3+/-1.5 hours after admission. All 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). 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.

• Authors: P Calès, C Masliah, B Bernard, P P Garnier, C Silvain, N Szostak-Talbodec, J P Bronowicki, D Ribard, D Botta-Fridlund, P Hillon, K Besseghir, D Lebrec, French Club for the Study of Portal Hypertension
• Journal: The New England journal of medicine (N Engl J Med) Vol. 344 Issue 1 Pg. 23-8 (Jan 04 2001) ISSN: 0028-4793 [Print] United States
• PMID: 11136956 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• vapreotide
• Somatostatin

Topics

• Blood Transfusion
• Combined Modality Therapy
• Endoscopy
• Esophageal and Gastric Varices (drug therapy, etiology, mortality, therapy)
• Female
• Gastrointestinal Hemorrhage (drug therapy, etiology, mortality, therapy)
• Humans
• Hypertension, Portal (complications)
• Liver Cirrhosis (complications, mortality)
• Male
• Middle Aged
• Multivariate Analysis
• Sclerotherapy
• Secondary Prevention
• Somatostatin (analogs & derivatives, therapeutic use)