Randomized controlled trial with terlipressin in cirrhotic patients with bleeding esophageal varices: Effects on precocious rebleeding and mortality rate

The efficacy and tolerability of terlipressin in the treatment of acute bleeding and rebleeding from esophageal varices were evaluated in a multicenter, controlled trial. During the first phase of the study, 219 cirrhotic patients with acute bleeding were treated with terlipressin (2 mg IV every 4 hours) and sclerotherapy on the first day and terlipressin alone (2 mg IV every 6 hours) on the second day. Twenty-two patients did not complete the first phase of the study, and the remaining 197 patients were randomly assigned to one of two groups during the second phase. From day 3 to day 7 of treatment, the patients in group A were treated with sclerotherapy alone while those in group B received sclerotherapy plus terlipressin (1 mg IV every 6 hours). From day 8 to day 28, both groups received sclerotherapy alone. During the first phase, hemostasis was achieved in 95.9% of the patients. Rebleeding occurred in 28 (29.5%) patients in group A and in 13 (12.7%) patients in group B. Terlipressin remarkably reduced the percentage of patients who experienced rebleeding but had no influence on the mortality rate.