Serum Creatinine Improvement and Outcomes in Hepatorenal Syndrome

Hepatorenal syndrome (HRS) is a severe form of acute kidney injury. It is life-threatening but potentially reversible. In the phase 3 CONFIRM study, more patients with HRS in the group treated with terlipressin achieved verified reversal of HRS compared with those in the placebo group (29.1% vs 15.8%, respectively; P=.012).

Juan Carlos Q. Velez and colleagues conducted a post hoc analysis of patient data from CONFIRM to determine whether an improvement in serum creatinine of >30% was associated with improved clinical outcomes. The researchers reported results of the analysis during a poster session at the American Society of Nephrology Kidney Week 2023 in a poster titled Improvement in Serum Creatinine Was Associated With Favorable Clinical Outcomes in Patients With Hepatorenal Syndrome: A Post Hoc Analysis of the CONFIRM Study.

Adults with cirrhosis, ascites, HRS, and a serum creatinine level of ≥2.25 mg/dL with projected doubling in serum creatinine within 2 weeks were enrolled in the CONFIRM study. Patients treated intravenously with terlipressin 1 mg every 6 hours were matched with patients in the placebo arm. Patients in both arms received recommended albumin. Patients from the CONFIRM intent-to-treat population were analyzed based on improvement (>30% vs ≤30%) in serum creatinine level from baseline (day 0 or a prestudy value if day 0 value is missing) to the end of treatment for length of intensive care unit (ICU) stay; incidence of renal replacement therapy (RRT); RRT-free survival at days 30, 60, and 90; and survival at day 90.

More patients in the terlipressin group had a >30% improvement in serum creatinine from baseline to end of treatment than patients in the placebo group (43.7% vs 21.8%, respectively; P<.001). Of patients admitted to the ICU, mean length of stay was numerically shorter among patients who had a >30% improvement in serum creatinine versus those who had a ≤30% improvement in serum creatinine (5.8 days vs 9.4 days, respectively; P=.673).

At day 90, RRT was required in fewer patients in the >30% improvement in serum creatinine group (18.3% vs 40.3%; P<.001). Overall, a higher proportion of patients (n=300; terlipressin + placebo combined) who achieved a >30% improvement in serum creatinine were alive (67.0% vs 42.9%; P<.001); and alive and RRT-free by day 90 (55.0% vs 20.4%; P<.001).

“Significantly more patients in the terlipressin group achieved a >30% improvement in serum creatinine versus placebo. Patients with a >30% improvement in serum creatinine had significant improvements in clinical outcomes through day 90,” the authors said.

Source: Velez JCQ, Mujtaba MA, Elsiesy H, Jamil K. Improvement in serum creatinine was associated with favorable clinical outcomes in patients with hepatorenal syndrome: a post hos analysis of the CONFIRM study. TH-PO052. Abstract of a poster presented at the American Society of Nephrology Kidney Week 2023; November 2, 2023; Philadelphia, Pennsylvania.