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

R. Brůha, Z. Mareček, V. Procházka, J. Lata, J. Špičák, J. Ehrmann, R. Kroupa, J. Petrtýl, J. Dolina, P. Taimr, P. Drastich, P. Urbánek, D. Vrzalová

. 2009 ; 56 (90) : 390-394.

Language English Country Greece

Document type Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc11019590

Grant support
NR9406 MZ0 CEP Register

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.

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$a Double-blind randomized multicenter study comparing the efficacy and safety of 10-day to 5-day terlipressin treatment of bleeding esophageal varices / $c R. Brůha, Z. Mareček, V. Procházka, J. Lata, J. Špičák, J. Ehrmann, R. Kroupa, J. Petrtýl, J. Dolina, P. Taimr, P. Drastich, P. Urbánek, D. Vrzalová
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$a Charles University in Prague, First Faculty of Medicine, 4th Department of Internal Medicine Prague, Czech Republic. bruha@cesnet.cz
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$a 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.
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