For patients with type 1 hepatorenal syndrome (HRS-1), terlipressin is more effective than placebo for reversal of HRS, according to a study published in the March 4 issue of the New England Journal of Medicine.
Florence Wong, M.B.B.S., from the University of Toronto, and colleagues conducted a phase 3 trial to confirm the efficacy and safety of terlipressin plus albumin in 300 adults with HRS-1. Patients were randomly assigned to receive either terlipressin (199 patients) or placebo (101 patients) for up to 14 days; concomitant use of albumin was strongly recommended in both groups. Verified reversal of HRS was the primary end point.
The researchers found that 32 and 17 percent of patients in the terlipressin and placebo groups, respectively, had verified reversal of HRS. Three of the four prespecified secondary end points were met by significantly more patients in the terlipressin group than in the placebo group. Liver transplantation had been performed in 23 and 29 percent of patients in the terlipressin and placebo groups, respectively, at day 90, and death occurred in 51 and 45 percent, respectively. Compared with placebo, there were more adverse events reported in the terlipressin group. Death within 90 days due to respiratory disorders occurred in 11 and 2 percent of patients in the terlipressin and placebo groups, respectively.
“Overall, the results of the CONFIRM study are in accordance with the data from previous clinical trials that provide evidence that terlipressin improves kidney function in patients with HRS-1,” the authors write.
The study was funded by Mallinckrodt Pharmaceuticals, the manufacturer of terlipressin.