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

Abstract

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.

• Authors: Radan Bruha, Zdenek Marecek, Vlastimil Prochazka, Jan Lata, Julius Spicak, Jiri Ehrmann, Radek Kroupa, Jaromir Petrtyl, Jiri Dolina, Pavel Taimr, Pavel Drastich, Petr Urbanek, Drahomira Vrzalova
• Journal: Hepato-gastroenterology (Hepatogastroenterology) 2009 Mar-Apr Vol. 56 Issue 90 Pg. 390-4 ISSN: 0172-6390 [Print] Greece
• PMID: 19579605 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Vasoconstrictor Agents
• Lypressin
• Terlipressin

Topics

• Double-Blind Method
• Esophageal and Gastric Varices (drug therapy)
• Female
• Humans
• Lypressin (administration & dosage, analogs & derivatives, therapeutic use)
• Male
• Middle Aged
• Safety
• Statistics, Nonparametric
• Terlipressin
• Treatment Outcome
• Vasoconstrictor Agents (administration & dosage, therapeutic use)