Terlipressin, a synthetic long-acting vasopressin analogue, was assessed for its effect in hepatorenal syndrome and concomitant alcoholic hepatitis.
The phase 3 CONFIRM trial included 300 participants with type 1 hepatorenal syndrome (HRS), cirrhosis, and rapid progressive renal failure, who were randomly assigned to receive either terlipressin or placebo. Notably, the study included those with suspected or confirmed alcoholic hepatitis, a condition that exacerbates the already high mortality risk of HRS.
Alcoholic hepatitis was identified in about 40% of study participants at baseline in both the terlipressin and placebo groups. Among this population subgroup, terlipressin proved significantly superior in achieving verified reversal of HRS, the primary endpoint. Terlipressin showed a success rate of HRS reversal of 30.9% compared with 7.7% for placebo (P=0.005). Rates of renal replacement therapy by day 30 were slightly lower in the terlipressin group (21%) compared with the placebo group (25.6%), albeit this finding was not statistically significant.
While rates of ICU admission were similar between the subgroups, the terlipressin-treated participants had a shorter average ICU length of stay (6.9 days vs 12.4 days). Transplant-free survival was also numerically higher in the terlipressin group, with a median of 28 days versus 15 days in the placebo group, although the difference was not statistically significant.
These findings suggest that terlipressin treatment is associated with higher rates of verified HRS reversal in participants with concomitant alcoholic hepatitis, with a trend toward lower rates of renal replacement therapy and shorter ICU stays. “These data strongly support a role for terlipressin for those with type 1 HRS and alcohol-associated hepatitis,” said Kevin Korenblat, MD.
Despite the promising results, further research is needed to definitively establish the potential benefits of terlipressin in this patient subgroup.
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