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


METHODS
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.
Bruha
Radan
R
Charles University in Prague, First Faculty of Medicine, 4th Department of Internal Medicine Prague, Czech Republic. bruha@cesnet.cz
Marecek
Zdenek
Z
Prochazka
Vlastimil
V
Lata
Jan
J
Spicak
Julius
J
Ehrmann
Jiri
J
Kroupa
Radek
R
Petrtyl
Jaromir
J
Dolina
Jiri
J
Taimr
Pavel
P
Drastich
Pavel
P
Urbanek
Petr
P
Vrzalova
Drahomira
D
D004311:Double-Blind Method; D004932:Esophageal and Gastric Varices / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008236:Lypressin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012449:Safety; D018709:Statistics, Nonparametric; D000077585:Terlipressin; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000627:therapeutic use*
D014662:Vasoconstrictor Agents; D008236:Lypressin; D000077585:Terlipressin