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Abstract: TH-PO050

Terlipressin Therapy in Patients with HRS and Comorbidities: The North American Experience

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials


  • 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

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.


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.


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).


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


  • Commercial Support – Mallinckrodt Pharmaceuticals