DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL COMPARING TERLIPRESSIN AND SOMATOSTATIN FOR ACUTE VARICEAL HEMORRHAGE

Background & Aims: Terlipressin and somatostatin decrease portal press ure and have been used to treat variceal hemorrhage, but they have not been adequately compared, The aim of this study was to compare the ef ficacy and safety of these drugs in the treatment of variceal bleeding in cirrhotic patients. Methods: Of 161 patients with variceal bleedin g, 80 were randomized to receive (double-blind) intravenous terlipress in (2 mg/4 h) and 81 to receive somatostatin (continuous infusion of 2 50 mu g/h after an intravenous injection of 250 mu g). Success of ther apy was defined as a 24-hour bleeding-free period within 48 hours from randomization, Results: Success of therapy was similar with terlipres sin (80%) and somatostatin (84%), In patients with Child's class A and B disease, terlipressin was effective in 52 of 60 (87%) and somatosta tin in 48 of 55 (87%), Success rates in class C were 60% and 77% (P = 0.33). No differences were observed in rebleeding rates (30% vs, 28.4% ) and 6-week mortality rates (13 vs, 13 patients), Incidence of side e ffects was significantly higher in the terlipressin group (38.8% vs. 2 3.5%; P = 0.042), Severe side effects requiring intervention occurred in 5 of 80 and 4 of 81 patients, respectively. Conclusions: Terlipress in and somatostatin are highly effective as first-line treatment of va riceal hemorrhage in cirrhotic patients, The low incidence of severe s ide effects suggests that drug therapy may be maintained for longer pe riods to prevent early rebleeding.