Terlipressin reduced need for renal replacement therapy 1 year after liver transplant
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CHARLOTTE, N.C. — A subgroup analysis of liver transplant patients with hepatorenal syndrome type 1 demonstrated that terlipressin decreased the need for renal replacement therapy up to 12 months following transplantation.
The findings, which presented extended data from the phase 3 randomized, placebo controlled CONFIRM trial, were presented at the ACG Annual Scientific Meeting.
“There was a reduced rate of renal replacement therapy both pretransplant and posttransplant through 12 months of follow-up,” K. Rajender Reddy, MD, FACG, the Ruimy Family President’s Distinguished Professor and director of hepatology and medical director of liver transplantation at the University of Pennsylvania, said during his presentation. “Among transplant recipients, overall survival through 12 months of follow-up was 11% higher for those treated with terlipressin (Mallinckrodt Pharmaceuticals) vs. placebo.”
He added, “The incidence of posttreatment [adverse events] and [serious adverse events] was similar between the groups, so these data would suggest that terlipressin treatment in patients with HRS led to better long-term clinical outcome primarily of decreased need for renal replacement therapy posttransplant.”
Reddy and colleagues examined the incidence of verified HRS (defined as two consecutive qualified serum creatinine levels of 1.5 mg/dL, at 2 hours apart, up to day 14 of treatment and survival without renal replacement therapy (RRT) for at least 10 days); HRS reversal (defined as one serum creatinine measurement of 1.5 mg/dL while on treatment); the incidence of RRT at 30, 60, 90, 180 and 365 days after liver transplant; and overall survival at these timepoints for 199 patients with HRS treated with terlipressin and albumin and 101 patients treated with placebo and albumin.
Overall, 46 patients in the terlipressin-treatment group and 29 patients in the placebo group received liver transplants. Three patients in the terlipressin group underwent simultaneous kidney and liver transplant vs. two patients in the placebo group.
Among the transplant recipients, “verified hepatorenal syndrome reversal was achieved by 37% of terlipressin-treated patients compared to 17% of those who received placebo,” Reddy said. “HRS reversal was achieved by 37% of terlipressin-treated patients compared to 14% of the placebo group,” he added.
Investigators found a significantly lower incidence of RRT pretransplant for the terlipressin group vs. the placebo group (14/46 patients vs. 18/29 patients). Posttransplant, the terlipressin group had a significantly lower incidence of RRT at both day 180 (9/46 patients vs. 12/26 patients) and day 360 (7/43 patients vs. 11/24 patients) compared with the placebo group. Twelve-month overall survival after transplant was 94% for the terlipressin group vs. 83% for the placebo group.
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Reddy KR, et al. Abstract S1173: Terlipressin treatment of patients with hepatorenal syndrome type 1 decreased the need for renal replacement therapy in transplant recipients: A 12-month follow-up of the CONFIRM study. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, N.C. (hybrid).
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