Terlipressin for Hepatorenal Syndrome in Patients With Early‐Stage Acute‐on‐Chronic Liver Failure

作者：Don C. Rockey, Fredric D. Gordon, Paul J. Thuluvath, David W. Victor, Nyingi Kemmer, Sanaz Cardoza, Khurram Jamil, R. Todd Frederick · 发表于：Liver International · 年份：2025 · DOI：10.1111/liv.70399 · 被引用次数：6 · 研究领域：Liver Disease and Transplantation、Drug-Induced Hepatotoxicity and Protection、Adrenal Hormones and Disorders

BACKGROUND & AIMS: Hepatorenal syndrome-acute kidney injury (HRS-AKI) is a life-threatening complication of decompensated cirrhosis. The US Food and Drug Administration approved terlipressin use for HRS-AKI based on the CONFIRM study, which demonstrated a significant improvement in HRS reversal with terlipressin versus placebo. The label notes elevated risk of respiratory failure in patients with volume overload or acute-on-chronic liver failure (ACLF) grade 3 and limited benefit when serum creatinine (SCr) exceeds 5 mg/dL. METHODS: We performed a post hoc analysis of CONFIRM excluding patients with ACLF grade 3 or SCr ≥ 5 mg/dL. This allowed us to assess the efficacy and safety of terlipressin in a population where the benefit-to-risk profile is more favourable. Efficacy outcomes included HRS reversal, renal replacement therapy (RRT), liver transplantation (LT), RRT-free survival, LT-free survival and overall survival. Changes in SCr, Model for End Stage Liver Disease (MELD) and sodium were also assessed. RESULTS: HRS reversal occurred in 43% (60/141) of patients with terlipressin versus 17% (13/75) with placebo (p < 0.001). Terlipressin was associated with significantly larger reductions (vs. placebo) in SCr (p < 0.001) and increases in serum sodium (p < 0.001). Importantly, LT rates were similar even though MELD scores decreased. 90-day survival was similar between treatment arms. Notably, selecting patients with a favourable benefit-to-risk profile led to a similar incide...