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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
Author(s) -
Sanyal A. J.,
Boyer T. D.,
Frederick R. T.,
Wong F.,
Rossaro L.,
Araya V.,
Vargas H. E.,
Reddy K. R.,
Pappas S. C.,
Teuber P.,
Escalante S.,
Jamil K.
Publication year - 2017
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.14052
Subject(s) - terlipressin , hepatorenal syndrome , medicine , placebo , renal function , albumin , gastroenterology , creatinine , urology , anesthesia , surgery , cirrhosis , pathology , alternative medicine
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).