Martín-Llahí M, Pépin MN, Guevara M et al.; TAHRS Investigators.
University of Barcelona, Barcelona, Spain.
Gastroenterology 2008;134:1352–9.
[2] A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome.
Sanyal AJ, Boyer T, Garcia-Tsao G et al.; Terlipressin Study Group.
Virginia Commonwealth University, Richmond, VA, USA.
Gastroenterology 2008;134:1360–8.
Editor’s note: Two randomized trials of terlipressin plus albumin versus albumin alone in patients with hepatorenal syndrome (HRS) were recently published in the same issue of
Gastroenterology [1,2]. The first study, by Martín-Llahí et al., did not include a placebo [1]. In this trial, out of 67 consecutive patients with cirrhosis and HRS who were assessed for inclusion in the study, 46 individuals with HRS type 1 or type 2 with creatinine levels of >175 µmol/L were recruited from nine tertiary referral centers over a 4-year period. This in itself indicates a limitation of the study owing to the restricted current definitions of HRS, which only apply to the minimal proportion of subjects with cirrhosis who have severe oliguria (
Hepatology 1996;23:164–76). Patients were randomly assigned in equal numbers to receive terlipressen plus albumin, or albumin alone. Terlipressin was initially administered intravenously at 1 mg every 4 h for 3 days. At that time, if serum creatinine levels had not decreased by ≥25% of the pretreatment values, the dose was increased to 2 mg every 4 h. Albumin was initially administered as 1 g/kg followed by 20–40 g/day to maintain central venous pressure at 10–15 cmH
2O. The primary endpoints of the study were improvement in renal function – defined as either a reduction in serum creatinine levels to <133 µmol/L or a reduction of >50% of the baseline value – and survival at 3 months.