Title
Terlipressin in combination with albumin as a therapy for hepatorenal syndrome in patients aged 65 years or older
Authors
Muhammad A. Mujtabaa, *, Ann Kathleen Gamilla-Crudoa , Shehzad N. Merwata , Syed A. Hussaina , Michael Kuehta , Aftab Karimb , Muhammad W. Khattakc , Peggy J. Rooneyd , Khurram Jamil
Journal
Annuals of Hepatology
Abstract
Introduction and Objectives: Clinical data for older patients with advanced liver disease are limited. This post hoc analysis evaluated the efficacy and safety of terlipressin in patients aged ≥65 years with hepatorenal syndrome using
data from 3 Phase III, randomized, placebo-controlled studies (OT-0401, REVERSE, CONFIRM).
Patients and Methods: The pooled population of patients aged ≥65 years (terlipressin, n = 54; placebo, n = 36) was evaluated for hepatorenal syndrome reversal—defined as a serum creatinine level ≤1.5 mg/dL (≤132.6 mmol/L)
while receiving terlipressin or placebo, without renal replacement therapy, liver transplantation, or death—and the incidence of renal replacement therapy (RRT). Safety analyses included an assessment of adverse events.
Results: Hepatorenal syndrome reversal was almost 2-times higher in terlipressin-treated patients compared with patients who received placebo (31.5% vs 16.7%; P = 0.143). Among surviving patients, the need for RRT was significantly reduced
in the terlipressin group, with an almost 3-times lower incidence of RRT versus the placebo group (Day 90: 25.0% vs 70.6%; P = 0.005). Among 23 liver-transplant-listed patients, significantly fewer patients in the terlipressin versus placebo group
needed RRT by Days 30 and 60 (P = 0.027 each). Fewer patients in the terlipressin group needed RRT post-transplant (P = 0.011). More terlipressin-treated patients who were listed for and received a liver transplant were alive and RRT-free by Day 90.
No new safety signals were revealed in the older subpopulation compared with previously published data.
Conclusions: Terlipressin therapy may lead to clinical improvements in highly vulnerable patients aged ≥65 years with hepatorenal syndrome.