TERLIPRESSIN PLUS TRANSDERMAL NITROGLYCERIN VS OCTREOTIDE IN THE CONTROL OF ACUTE BLEEDING FROM ESOPHAGEAL-VARICES - A MULTICENTER RANDOMIZED TRIAL

We undertook a multicenter randomized trial to compare the efficacy of terlipressin combined with transdermal nitroglycerin and that of octr eotide in the emergency control of acute variceal hemorrhage in cirrho sis. Over 16 mo, 87 patients with endoscopically proved active bleedin g from esophageal or cardiac varices were enrolled in five centers in France and randomly assigned to receive intravenous terlipressin (2 mg and then 1 mg/4 hr over 24 hr) and transdermal nitroglycerin (10 mg/1 2 hr over 24 hr) (group 1) or octreotide (continuous intravenous infus ion of 25 mug/hr over 12 hr and then 100 mug at hr 12 and hr 18 subcut aneously) (group 2). Initial control of bleeding was assessed at the e nd of 12 hr of treatment on the basis of stability of blood pressure a nd hematocrit level with no further transfusion requirements. At 12 hr , bleeding was controlled in 59% (24 of 41) in group 1 and 78% (36/46) of group 2 patients (Fisher's exact test, p = 0.064). Mean transfusio n requirements over this 12-hr period were significantly greater in gr oup 1 (three blood units; range = 0 to 13) than in group 2 (one blood unit; range = 0 to 5) (p = 0.002). After the first 12 hr. 20% of patie nts (5 of 24) had repeat bleeding in group 1 compared with 27% (10 of 36) in group 2. During the first 48-hr period, five patients (12%) die d in group 1, compared with 3 (6%) in group 2. Few side effects were n oted in either group. However, in group 1 two patients experienced sev ere bradycardia; it resulted in death in one patient. Octreotide appea red to be as effective as terlipressin combined with transdermal nitro glycerin in the emergency control of active variceal bleeding in cirrh osis, with significantly smaller transfusion requirements and only min or side effects.