Terlipressin plus albumin for the treatment of type 1 hepatorenal syndrome
New England Journal of Medicine Mar 13, 2021
Wong F, Pappas SC, Curry MP, et al. - In many parts of the world, the vasoconstrictor terlipressin is used to treat type 1 hepatorenal syndrome (HRS-1) and is part of the clinical practice guidelines in Europe, so researchers tested the safety and effectiveness of terlipressin plus albumin in adults with HRS-1. For this phase 3 trial, study participants were randomized in a 2:1 ratio to terlipressin or placebo for up to 14 days. Concomitant use of albumin was strongly recommended in both groups. In total, 300 patients were randomized, with 199 allocated to the terlipressin group and 101 to the placebo group. Terlipressin was more effective than placebo in improving renal function in adults with cirrhosis and HRS-1 in this study, but it was linked with severe adverse events, including respiratory failure. Reversal of HRS was verified in 32% of the terlipressin group and 17% of the placebo group. Liver transplantations had been performed in 23% of patients in the terlipressin group and 29% of patients in the placebo group at day 90. In 22 patients (11%) in the terlipressin group and 2 patients (2%) in the placebo group, death within 90 days due to respiratory disorders was seen.
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