Abstract: TH-PO050
Terlipressin Therapy in Patients with HRS and Comorbidities: The North American Experience
Session Information
- AKI: Liver Disease, Nephrotoxicity, Novel Therapeutics
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical, Outcomes, and Trials
Authors
- Wadei, Hani, Mayo Clinic, Jacksonville, Florida, United States
- Zhang, Zhiwei, Mayo Clinic, Jacksonville, Florida, United States
- Alzubaidi, Mo, Columbia Nephrology Associates, Columbia, South Carolina, United States
- Jamil, Khurram, Mallinckrodt Pharmaceuticals, Bridgewater, New Jersey, United States
Background
Hepatorenal syndrome (HRS)—a rapid kidney failure—occurs in patients (pts) with decompensated cirrhosis and ascites. Terlipressin (Terli) is FDA-approved to treat pts with HRS. Certain pts with HRS and alcoholic hepatitis (AH), systemic inflammatory response syndrome (SIRS), or low mean arterial pressure (MAP) may suffer from a portal hypertension/splanchnic vasodilation-related inflammatory response, which may be attenuated by Terli.
Methods
Data from the 3 largest prospective, randomized, placebo (Pbo)-controlled, clinical studies in pts with HRS (OT-0401, REVERSE, and CONFIRM) were pooled to assess the role of Terli vs Pbo (both plus albumin) on HRS reversal in the subpopulation of pts with AH, MAP <70 mm Hg, or SIRS. HRS reversal was defined as at least 1 serum creatinine (SCr) value of ≤1.5 mg/dL while on treatment.
Results
In the pooled population, 394/608 pts had AH, SIRS, or low MAP, and 214/608 pts did not. At baseline, SCr and MELD score were comparable between treatment groups (gps). Among pts with AH, SIRS, or low MAP, HRS reversal was achieved by 81/233 (35%) pts in the Terli gp vs 21/161 (13%) pts in the Pbo gp (P<.001). Among pts with AH, SIRS, or low MAP, fewer pts in the Terli gp (vs Pbo gp) needed renal replacement therapy (RRT) by Day 30 (26% vs 35%, P=.049), Day 60 (28% vs 38%, P=.046), and Day 90 (30% vs 38%, P=.104). Overall survival (OS) up to 90 days demonstrated a positive trend in pts in the Terli gp vs the Pbo gp (P=.077; Figure).
Conclusion
Pts with HRS who had AH, SIRS, or low MAP had a significantly higher HRS reversal rate and lower RRT rate at Days 30 and 60, and a trend for better OS when randomized to Terli vs Pbo.
Figure. OS among patients with AH, SIRS, or MAP <70 mm Hg, pooled ITT population
Funding
- Commercial Support – Mallinckrodt Pharmaceuticals