Document Type
Article
Publication Date
12-10-2024
Abstract
INTRODUCTION: The degree of improvement in serum creatinine (SCr) has previously been suggested as a sensitive indicator of treatment response in patients with hepatorenal syndrome-acute kidney injury (HRS-AKI), while HRS reversal remains the primary endpoint in clinical trials.
METHODS: A total of ≥ 30% SCr improvement was analyzed as an exploratory prespecified endpoint in the CONFIRM trial. In this post hoc analysis, intent-to-treat population data from three Phase 3 studies (OT-0401, REVERSE, and CONFIRM) conducted in North America in patients with HRS-AKI were pooled to assess the incidence of > 30% improvement in SCr and its association with clinical outcomes.
RESULTS: Significantly more patients treated with terlipressin achieved > 30% improvement in SCr compared with those who received a placebo (42.9% vs. 23.4%; p < 0.001). Compared with patients who did not achieve > 30% improvement in SCr, those who achieved this threshold had a lower incidence of renal replacement therapy (RRT) (55.2% vs. 14%, respectively; p < 0.001) and greater overall survival at Day 90 (41.6% vs. 71.1%, respectively; p < 0.001); a greater proportion achieved durability of HRS reversal (1% [95% confidence interval, 95% CI: 0] vs. 68.9% [95% CI: 0.6, 0.8]) and more patients were alive without RRT (22.7% vs. 61.6%, respectively; p < 0.001) or transplant (11.6% vs. 43.0%, respectively; p < 0.0001). Additionally, the overall survival and RRT-free survival in the group that achieved > 30% improvement in SCr without HRS reversal were comparable to the overall
group that achieved HRS reversal.
CONCLUSION: A total of > 30% improvement in SCr levels even without HRS reversal may serve as a clinically meaningful endpoint to define renal recovery in patients with HRS-AKI.
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This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Recommended Citation
Mujtaba, Muhammad A.; Elsiesy, Hussien; Faiz, Sara; Hussain, Syed A.; Gamilla-Crudo, Ann Kathleen N.; Karim, Aftab; Khan, Mohammad I.; Khattak, Muhammad W.; Zafar, Zunaira; Kueht, Michael; and Jamil, Khurram, "Defining Renal Recovery in Patients With Hepatorenal Syndrome-Acute Kidney Injury: Experience From North American Studies" (2024). Jefferson Health - Northeast Papers (formerly Aria Health Papers). Paper 4.
https://jdc.jefferson.edu/ariafp/4
Supporting Information Figure 2.pdf (159 kB)
Supporting Information Figure 3.pdf (123 kB)
Language
English
PubMed ID
39664961
Included in
Digestive System Diseases Commons, Female Urogenital Diseases and Pregnancy Complications Commons, Hepatology Commons, Laboratory Medicine Commons, Male Urogenital Diseases Commons, Nephrology Commons, Therapeutics Commons
Comments
This article is the author's final published version in JGH Open, Volume 8, Issue 12, December 2024, Article number e70058.
The published version is available at https://doi.org/10.1002/jgh3.70058.
Copyright © 2024 The Author(s)