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Abstract Details
Terlipressin use and respiratory failure in patients with hepatorenal syndrome type 1 and severe acute-on-chronic liver failure
Aliment Pharmacol Ther. 2022 Aug 22. doi: 10.1111/apt.17195. Online ahead of print.
1Division of Gastroenterology and Hepatology, Department of Medicine, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
2Orphan Therapeutics LLC, Longboat Key, Florida, USA.
3Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
4Division of Gastroenterology/Hepatology, Mayo Clinic, Scottsdale, Arizona, USA.
5Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
6Department of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
7Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.
Abstract
Background: Previous studies suggest increased mortality in patients with hepatorenal syndrome type 1 (HRS1) and advanced acute-on-chronic liver failure (ACLF).
Aim: To assess mortality and respiratory failure (RF) in patients with HRS1 and ACLF treated with terlipressin.
Methods: In the CONFIRM study, we randomised 299 patients with HRS1 2:1 to terlipressin or placebo, both with albumin. At enrolment, all patients were assessed for organ failure (OF) using a validated ACLF grading system. Post hoc analyses assessed the effects of terlipressin vs. placebo on the incidence of RF and 90-day mortality.
Results: The incidence of RF with terlipressin (n = 200) was 9.4% in patients with grades 1-2 ACLF, and 30% with grade 3 ACLF (p = 0.0002); no such difference was observed in placebo-treated patients (n = 99) (6.2% grades 1-2 vs. 0% grade 3 ACLF, p > 0.05). RF incidence between terlipressin and placebo in patients with grade 3 ACLF was significant (p = 0.01). Baseline predictors of RF with terlipressin were INR (p = 0.011), mean arterial pressure (p = 0.037), and SpO2(p = 0.014). Prior albumin as a continuous variable was not a predictor of RF. 90-day survival between terlipressin and placebo arms was similar for grades 1-2 ACLF (55.5% and 56.6%, respectively), but lower for grade 3 ACLF (27.55% vs. 50.0%) (p = 0.122), mainly related to RF.
Conclusion: Terlipressin should be used with caution in patients with HRS1 and grade 3 ACLF. Patients with hypoxaemia are at increased risk of RF and mortality.
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