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Kidney Week

Abstract: TH-PO0769

Retrospective Cohort Study Evaluating Real-World Use and Outcomes of Terlipressin in US Adults Hospitalized with Hepatorenal Syndrome-AKI

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials

Authors

  • Barritt, Alfred Sidney, University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States
  • Patidar, Kavish Rohit, Division of Gastroenterology and Hepatology, Department of Medicine, Houston Methodist Hospital, Houston, Texas, United States
  • Wong, Robert, Stanford University School of Medicine, Palo Alto, California, United States
  • Huang, Xingyue, Mallinckrodt Hospital Products, Inc. (a Keenova Therapeutics company), Bridgewater, New Jersey, United States
  • Panaccio, Mary P., Mallinckrodt Hospital Products, Inc. (a Keenova Therapeutics company), Bridgewater, New Jersey, United States
  • Lilley, Jonathan, Boston Strategic Partners Inc, Boston, Massachusetts, United States
  • Wadhwani, Nisha, Boston Strategic Partners Inc, Boston, Massachusetts, United States
  • Rajkumar, Rahul, Boston Strategic Partners Inc, Boston, Massachusetts, United States
  • White, Chris, Mallinckrodt Hospital Products, Inc. (a Keenova Therapeutics company), Bridgewater, New Jersey, United States
Background

Hepatorenal syndrome-acute kidney injury (HRS-AKI) is a complication of decompensated cirrhosis with high mortality. Real-world evidence on terlipressin, the only FDA-approved treatment for HRS-AKI, is limited. We performed a retrospective cohort analysis of terlipressin use and outcomes in patients with HRS-AKI.

Methods

Using the Premier Healthcare Database, we identified U.S. adults hospitalized with HRS-AKI who received terlipressin for ≥2 days (Sep 2022-Feb 2026). HRS-AKI and terlipressin use were identified using ICD, National Drug, and billing codes. Patient/hospital characteristics, treatment patterns and clinical outcomes were evaluated.

Results

Among 575 patients with HRS-AKI, median age was 56y (IQR 46.0, 65.5), 63.5% were male, and 67.8% were managed at high-volume hospitals (≥500 beds). Alcohol-associated liver disease (ALD) was the leading cirrhosis etiology (74.3%). First-line treatments comprised terlipressin (24.3%), midodrine/octreotide (64.8%), norepinephrine (3.3%), and other combination regimens (7.5%). In a subset of 82 patients with available pre/post-treatment serum creatinine (SCr) data, 39% achieved HRS reversal (post-treatment SCr ≤1.5mg/dL). Patients with pre-treatment SCr <3mg/dL had higher response rates and lower in-hospital mortality compared with those with SCr ≥3mg/dL (42.6% vs. 34.3% and 10.6% vs. 20.0%, respectively). Overall, 25.2% of patients underwent renal replacement therapy (RRT), and 18.8% had in-hospital mortality. Median hospital stay was 16 days (IQR 10.0, 25.0); 22.3% were discharged to other facilities (skilled nursing facility, rehab, etc.), while 41.9% were discharged home.

Conclusion

In this real-world cohort of patients with HRS-AKI, only a quarter received terlipressin as first-line therapy despite guideline recommendations, highlighting a significant gap between real-world practice and current guidance. Among patients with available SCr data, approximately 40% achieved HRS reversal, with higher reversal rates and lower in-hospital mortality observed among those with lower pre-treatment SCr levels. Additionally, nearly 42% of all patients were discharged home and about a quarter to non-critical care facilities. These results suggest terlipressin may be effective, particularly when initiated at lower SCr levels, with potential improvements in clinical response and outcomes.

Funding

  • Commercial Support – Mallinckrodt Hospital Products, Inc. (a Keenova Therapeutics company, Bridgewater, NJ, USA)