RANDOMIZED CONTROLLED TRIAL OF DESMOPRESSIN PLUS TERLIPRESSIN VS TERLIPRESSIN ALONE FOR THE TREATMENT OF ACUTE VARICEAL HEMORRHAGE IN CIRRHOTIC-PATIENTS - A MULTICENTER, DOUBLE-BLIND-STUDY

1-Deamino-8-D-arginine vasopressin (DDAVP, desmopressin), a synthetic analog of the antidiuretic hormone L-arginine vasopressin, improves he mostasis parameters in cirrhotic patients. Hence its use in combinatio n with a vasoactive drug such as terlipressin might improve the perfor mance of this drug in controlling variceal bleeding. The aim of this t rial was to compare the efficacy of desmopressin plus terlipressin wit h that of terlipressin alone in controlling acute variceal hemorrhage. Cirrhotic patients with active variceal hemorrhage diagnosed endoscop ically were randomized within 2 hr of admission to receive desmopressi n plus terlipressin or placebo plus terlipressin. Terlipressin (2 mg, intravenous bolus) was given at time 0 and every 4 hr thereafter for 2 4 hr. Desmopressin (0.3 mug/kg, intravenously) or placebo was given in saline solution over 30 min at time 0 and at 26 hr. Patients were mon itored for 24 hr after cessation of treatment. Treatment failure was d efined as recurrence of active bleeding during treatment or within the 24 hr after treatment. After enrolling 51 of the planned 84 patients, we carried out an interim analysis. Treatment failure occurred in 13 of 24 patients randomized to receive desmopressin plus terlipressin (5 4.2%) and in 6 of 22 patients randomized to receive terlipressin (27.3 %) (p = 0.06, Fisher's exact test). The trial was interrupted at this stage because patients treated with the ''new'' therapy fared worse th an those treated with the standard therapy, and the possibility of rev ersing this trend by completing the trial was deemed remote. The addit ion of desmopressin does not improve and may worsen the efficacy of te rlipressin in controlling acute variceal bleeding in cirrhotic patient s.