Comparison of continuous versus intermittent infusions of terlipressin for the control of acute variceal bleeding in patients with portal hypertension: An open-label randomized controlled trial.

BACKGROUND

Continuous infusion of terlipressin causes more stable reduction in portal venous pressure than intermittent infusion. The aim of the study was to compare the efficacy of continuous infusion vs. intermittent boluses of terlipressin to control acute variceal bleeding (AVB) in patients with portal hypertension.

METHODS

Eighty-six consecutive patients with portal hypertension and AVB were randomized to receive either continuous intravenous infusion (Group A, n = 43) or intravenous boluses of terlipressin (Group B, n = 43). Group A received 1 mg intravenous bolus of terlipressin followed by a continuous infusion of 4 mg in 24 h. Group B received 2 mg intravenous bolus of terlipressin followed by 1 mg intravenous injection every 6 h. Upper gastrointestinal (UGI) endoscopy was done within 12 h of admission. Endoscopic variceal ligation (EVL) was done using a multi-band ligator. In both groups, treatment was continued up to 5 days. The primary endpoint was rebleeding or death within 5 days of admission.

RESULTS

Patients in group A had lower rate of treatment failure (4.7%) as compared to patients in group B (20.7%) (p = 0.02). Within 6 weeks, four and eight patients died in group A and B, respectively (p = 0.21). Model for end-stage liver disease sodium (MELD-Na) score and continuous infusion of terlipressin showed significant relationship with treatment failure on multivariate analysis.

CONCLUSIONS

Continuous infusion of terlipressin may be more effective than intermittent infusion to prevent treatment failure in patients with variceal bleeding. There is significant relationship between MELD-Na score [Odd ratio = 1.37 (95% CI-1.16 - 1.62), p-value < 0.001] and continuous infusion of terlipressin [Odd ratio = 0.18 (95% CI-0.037 - 0.91), p-value - 0.04] with treatment failure.