Terlipressin improved renal function in patients with hepatorenal syndrome
Terlipressin improved renal function in patients with cirrhosis and type 1 hepatorenal syndrome (HRS-1) more effectively than placebo but was associated with serious adverse events, according to data published in New England Journal of Medicine.
In this phase 3 trial, 300 patients with HRS-1 were randomly assigned in a 2:1 ratio to receive terlipressin (n = 199) or placebo (n = 101) for up to 14 days. Concomitant use of albumin was strongly recommended in both groups.
In the terlipressin group and the placebo group, verified reversal of HRS was reported in 32% and 17% of patients, respectively.
In the terlipressin group and the placebo group, 39% and 18% of patients, respectively, had HRS reversal, defined as any serum creatinine level of 1.5 mg per deciliter or less during the first 14 days and HRS reversal without renal-replacement therapy by day 30, in 34% and 17%, respectively;
Among the 84 patients in the terlipressin group and 48 patients in the placebo group with systemic inflammatory response syndrome, 37% and 6% reported HRS reversal. Verified reversal of HRS without recurrence by day 30 was reported in 26% and 17%, respectively.
At day 90, liver transplantations had occurred in 23% of patients in the terlipressin group and 29% of patients in the placebo group; death occurred in 51% and 45%, respectively.
Adverse events, including abdominal pain, nausea, diarrhea, and respiratory failure, occurred more often in patients taking terlipressin than with placebo.
In 11% of patients in the terlipressin group and 2% in the placebo group, death within 90 days due to respiratory disorders occurred.
Wog F, Pappas C, Curry MP, et al. Terlipressin plus albumin for the treatment of type 1 hepatorenal syndrome. N Engl J Med. 2021; 384:818-828. DOI: 10.1056/NEJMoa2008290