Double-blind randomized multicenter study comparing the efficacy and safety of 10-day to 5-day terlipressin treatment of bleeding esophageal varices.

摘要

BACKGROUND/AIMS: The aim of the study was to compare the efficacy and safety of 5-day terlipressin treatment of bleeding esophageal varices to 10-day treatment period. METHODOLOGY: Of 25 patients with variceal bleeding, 15 were randomized to receive terlipressin for day 1-5 and placebo for day 6-10 (Group A), and 10 to receive terlipressin for day 1-10 (Group B). RESULTS: The bleeding was stopped in 24 patients (96%). Rebleeding till day 42 was observed in 9 (36%) patients (5 in group A, 4 in group B, ns). 2 patients died in group B (due to rebleeding till day 5) and one in group A (rebleeding between day 5-10). Transfusion needs were lower in group B (2.7 +/- 2.6TU compared to 4.13 +/- 5.8 TU in group A, ns). Serious AE leading to treatment discontinuation were observed in 1 patient in group A (peripheral ischemia) and none in B, non-significant AE in 3 patients in group A (hypertension), and in 3 in group B (hypertension, hyponatremia, epiparoxysm). CONCLUSIONS: Prolonged treatment with terlipressin did not prove significant decrease of mortality or bleeding recurrence; lower rebleeding rate after day 5 and tendency towards lower transfusion requirements were observed. Prolonged treatment had no influence on AE rate.