Abstract: TH-PO034
Initiation of Terlipressin at Lower Serum Creatinine Levels Is Associated With Avoidance of Dialysis in Patients With Hepatorenal Syndrome Type 1
Session Information
- AKI: Biomarkers, Risk Factors, Treatments, Outcomes
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical‚ Outcomes‚ and Trials
Authors
- Velez, Juan Carlos Q., Ochsner Health Network LLC, New Orleans, Louisiana, United States
- Kurtz, Ira, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, United States
- Vierling, John M., Baylor College of Medicine, Houston, Texas, United States
- Gonzalez, Stevan A., Baylor Scott & White Health, Fort Worth, Texas, United States
- Jamil, Khurram, Mallinckrodt LLC, Clinton, New Jersey, United States
Background
Results from 3 North American, randomized, placebo (PBO)-controlled trials (RCTs [OT-0401, REVERSE, and CONFIRM]) demonstrated that terlipressin (TERLI) effectively reversed acute kidney injury (AKI) due to hepatorenal syndrome type 1 (HRS-1), and reduced the cumulative need for renal replacement therapy (RRT). However, factors associated with avoidance of RRT have not been formally examined.
Methods
A pooled analysis of the 3 RCTs in patients with HRS-1 (OT-0401, REVERSE, and CONFIRM) was conducted to compare the efficacy of TERLI + albumin vs. PBO + albumin. Logistic regression analysis was used to evaluate baseline characteristics associated with avoidance of RRT by Day 90. Numerical values were used as continuous variables. Patients who died without undergoing RRT were excluded to eliminate death as a potential confounder.
Results
In the pooled cohort, the following factors were significantly associated with a lower odds of avoidance of RRT by Day 90: a higher serum creatinine (SCr) level at study entry ([n=412], odds ratio [OR], 0.55; 95% CI: 0.44–0.68; P<.001) and higher scores for liver disease severity (Child Pugh score [n=393]; OR, 0.89; 95% CI: 0.80–0.99, P=.037; and MELD score [n=361]; OR, 0.96; 95% CI: 0.93–0.99; P=.010). Randomization to TERLI (n=412) was significantly associated with a greater odds of avoidance of RRT (OR, 1.57; 95% CI: 1.06–2.33; P=.025). In contrast, age, male sex, race, alcoholic hepatitis, baseline mean arterial pressure (MAP), serum sodium, serum albumin, total bilirubin, INR, prior albumin use, presence of precipitating factors for HRS, or prior use of midodrine/octreotide were not associated with avoidance of RRT. Among TERLI-treated patients, a higher SCr level (n=241; P<.001) and MELD score (n=213; P=.01) were significantly associated with a lower odds of avoidance of RRT. Among PBO-treated patients (n=171), a higher SCr level (P<.001) and lower MAP (P=.008) were associated with a lower odds of avoidance of RRT.
Conclusion
TERLI treatment at a lower SCr level and MELD score was associated with a greater probability of avoiding RRT by Day 90 in patients with HRS-1. Thus, initiation of TERLI in patients with a lower SCr may reduce the need for RRT in patients with AKI due to HRS-1.
Funding
- Commercial Support – Mallinckrodt Pharmaceuticals