Terlipressin vs. octreotide in bleeding esophageal varices as an adjuvant therapy with endoscopic band ligation: a randomized double-blind placebo-controlled trial

Abstract

Objectives: Data are scarce on the head-to-head efficacy of terlipressin and octreotide as an adjuvant therapy to endoscopic management of variceal bleed. The aim of this study was to compare the efficacy and safety of terlipressin with octreotide as an adjuvant therapy to endoscopic variceal band ligation in patients with esophageal variceal bleeding.

Methods: Cirrhotic patients with esophageal variceal bleed were randomized on admission to receive terlipressin (group A) or octreotide (group B) along with the placebo in the other arm in a double-blind fashion. The two groups were compared for efficacy, safety, overall survival, and length of hospital stay. "Control of variceal bleed" was the measure of efficacy of terlipressin and octreotide. Factors predicting length of stay were also assessed.

Results: A total of 324 patients were enrolled; 163 in the terlipressin group (group A) and 161 in the octreotide group (group B). The baseline characteristics of the two groups were comparable for age, gender, etiology of cirrhosis, hemoglobin at presentation, and Child-Pugh class, except that active bleed was seen during upper gastrointestinal endoscopy at the time of enrollment in 26 (16%) and 41 (25.5%) patients in groups A and B, respectively (P=0.034). Overall sixteen patients died (three failure to control bleed and thirteen from causes other than variceal bleed); nine in group A (5.5%) and seven (4.3%) in group B (P=0.626). In the intention to treat analysis, "control of variceal bleed" was noted in 305 patients (94.13%); 151 (92.63%) patients in group A and 154 (95.6%) patients in group B (confidence interval: 0.219-1.492). Packed cell transfusions in group A were 3.7+/-2.3 units, whereas in group B there were 3.9+/-2.5 units (P=0.273). Length of hospital stay in groups A and B was 108.40+/-34.81 and 126.39+/-47.45 h, respectively (P< or =0.001). No cardiovascular side effects were observed in either group. High pulse, low hemoglobin, prothrombin time, blood in nasogastric aspirate, and portosystemic encephalopathy (PSE) were predictors of prolonged hospital stay.

Conclusions: The efficacy of terlipressin was not inferior to octreotide as an adjuvant therapy for the control of esophageal variceal bleed and in-hospital survival. The length of hospital stay in the terlipressin group was significantly shorter but not of any clinical importance. The predictors of prolonged hospital stay were low hemoglobin, high pulse, prolonged prothrombin time, blood at nasogastric aspirate, and PSE.