TERLIPRESSIN OR VASOPRESSIN PLUS TRANSDERMAL NITROGLYCERIN IN A TREATMENT STRATEGY FOR DIGESTIVE BLEEDING IN CIRRHOSIS - A RANDOMIZED CLINICAL-TRIAL

Between 1988 and 1990 an unblinded, randomized trial of terlipressin o r vasopressin plus transdermal nitroglycerin, as part of a treatment s trategy including emergency sclerotherapy for actively bleeding varice s, was conducted during 165 admissions in 137 patients with cirrhosis and upper digestive bleeding. Eighty-four patient admissions were assi gned to terlipressin (2 mg every 6 h) and 81 to vasopressin (0.4 to 0. 8 unit per min) plus transdermal nitroglycerin (20 to 80 mg). The two groups were comparable for relevant clinical data, but there were slig htly more patients with hepatocellular carcinoma or terminal condition s in the terlipressin group. After the 24-h study period, failure to c ontrol bleeding was 20/84 (25%) in the vasopressin and 14/81 (17%) in the terlipressin group (p=0.19). Corresponding figures for patients bl eeding from varices (emergency sclerotherapy in 43 and 45, respectivel y) were 13/55 (24%) and 5/56 (9%; p=0.035), from other sources 5/16 (3 1%) and 2/15 (13%; p=0.23), from undefined sources 2/10 (20%) and 7/13 (54%; p=0.1). In a logistic multivariate regression model the odds ra tio for terlipressin adjusted for prognostic factors was 0.45 (p=0.07) . There were seven major side effects requiring treatment discontinuat ion in the vasopressin and one in the terlipressin group. These result s suggest that terlipressin alone is as effective as vasopressin plus transdermal nitroglycerin, with less severe side effects, in 24-h cont rol of upper gastrointestinal bleeding in patients with cirrhosis. (C) Journal of Hepatology.