INTRODUCTION: Terlipressin, a vasoconstrictor is sued for type 1 hepatorenal syndrome (HRS-1) around the globe and is included in the European clinical practice guidelines. This study intended to assess the efficacy and safety of terlipresisn and albumin in adults with HRS-1. 

METHOD: Phase 3 trial, where the patients were randomly assigned in a 2:1 ratio to receive terlipresisn or placebo for up to 14 days; in both groups, concomitant use of albumin was strongly advised. THE primary end point was verified reversal of HRS, defined as two consecutive serum creatinine measurements of 1.5 mg per decilitre or less at least 2 hours apart and survival without renal-replacement therapy for at least 10 days after the completion of treatment. 

RESULTS: The total study participants were 300 patients who underwent randomization -199 were assigned to the terlipresisn group and 101 to the placebo group. Verified reversal of HRS was reported in 63 patients (32%) in the terlipressin group and 17 patients (17%) in the placebo group (P=0.006). At day 90, liver transplantations had been performed in 46 patients (23%) in the terlipressin group and 29 patients(295) in the placebo group, and death occurred in 101 (51%) and 45 (45%), respectively. Additional adverse events, including abdominal pain, nausea, diarrhoea, and respiratory failure, occurred with terlipresisn than with placebo. Death within 90 days due to respiratory disorders occurred in 22 patients (11%) in the terlipresisn group and 2 patients (2%) in the placebo group. 

CONCLUSION: Based on the study results, the study authors concluded that terlipressin was more effective than placebo in improving renal function but was linked to serious adverse events, including respiratory failure. 

Reference: Wong F, Pappas C, Curry JDM, Reddy KR, et al. Terlipressin plus albumin for the treatment of type 1 hepatorenal syndrome. The New England Journal of Medicine 2021; 384:818-828.