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Summary   Background  The goal of hepatorenal syndrome type 1 ( HRS ‐1) treatment is to improve renal function. Terlipressin, a synthetic vasopressin analogue, is a systemic vasoconstrictor used for the treatment of  HRS ‐1, where it is available.    Aim  To compare the efficacy of terlipressin plus albumin vs. placebo plus albumin in patients with  HRS ‐1.    Methods  Pooled patient‐level data from two large phase 3, randomised, placebo‐controlled studies were analysed for  HRS  reversal [serum creatinine ( SC r) value ≤133 μmol/L], 90‐day survival, need for renal replacement therapy and predictors of  HRS  reversal. Patients received intravenous terlipressin 1–2 mg every 6 hours plus albumin or placebo plus albumin up to 14 days.    Results  The pooled analysis comprised 308 patients (terlipressin:  n  =   153; placebo:  n  =   155).  HRS  reversal was significantly more frequent with terlipressin vs. placebo (27% vs. 14%;  P  =   0.004). Terlipressin was associated with a more significant improvement in renal function from baseline until end of treatment, with a mean between‐group difference in  SC r concentration of −53.0 μmol/L ( P  <   0.0001). Lower  SC r, lower mean arterial pressure and lower total bilirubin and absence of known precipitating factors for  HRS  were independent predictors of  HRS  reversal and longer survival in terlipressin‐treated patients.    Conclusions  Terlipressin plus albumin resulted in a significantly higher rate of  HRS  reversal vs. albumin alone in patients with  HRS ‐1. Terlipressin treatment is associated with improved renal function. (ClinicalTrials.gov identifier:  OT ‐0401,  NCT 00089570;  REVERSE ,  NCT 01143246).

alimentary pharmacology and therapeutics

Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the  OT ‐0401 and  REVERSE  randomised clinical studies