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Abstract: SA-OR03

Effect of Terlipressin Treatment on the Incidence of Renal Replacement Therapy in Patients with Hepatorenal Syndrome and Fluid Overload: A Post Hoc Analysis of the Phase 3 CONFIRM Study

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials

Authors

  • Wadei, Hani, Mayo Clinic, Jacksonville, Florida, United States
  • Mujtaba, Muhammad Ahmad, University of Texas Medical Branch, Galveston, Texas, United States
  • Jamil, Khurram, Mallinckrodt Pharmaceuticals, Bridgewater, New Jersey, United States
Background

Terlipressin (terli) is an FDA-approved vasopressin analogue for the treatment of patients with hepatorenal syndrome (HRS). However, in the Phase III CONFIRM study, terli use was associated with respiratory failure in 10% of terli-treated patients; this could have been due to increased intravascular volume, which is often managed with renal replacement therapy (RRT). In this analysis, we retrospectively examined the subgroup of patients in CONFIRM with fluid overload to determine the incidence, indications, and modality of RRT.

Methods

This post hoc analysis of the Phase III, randomized, placebo (pbo)-controlled CONFIRM study (NCT02770716) evaluated the incidence of RRT, indications, and modes of RRT used, in the subgroup of patients with fluid overload (pooled term for: hemodynamic edema, effusions, and fluid overload), as determined by investigator assessment. Incidence of RRT was determined on Days 14, 30, 60, and 90 in patients treated with terli or pbo; RRT was initiated after treatment discontinuation. Indications and mode of RRT were determined up to Day 14. Statistical analysis was determined using a Chi-square or Fisher Exact test.

Results

The CONFIRM study enrolled 300 patients (terli, n=199; pbo, n=101), of which 88 patients had fluid overload (terli: n=69; pbo, n=19). RRT incidence was significantly lower in the terli versus pbo group by Day 14 (23.2% [16/69] vs 47.4% [9/19], P=.039), and similar results were observed by Days 30, 60, and 90 (P≤.05). The indications for RRT up to Day 14 did not differ significantly between treatment groups, and the most common indications for both terli and pbo were fluid overload (14.5% [10/69] vs 15.8% [3/19]; P=1.000) and pulmonary edema (5.8% [4/69] vs 10.5% [2/19]; P=.606). Hemodialysis (terli vs pbo: 10.1% [7/69] vs 36.8% [7/19], P=.005) was the only mode of RRT with a significant difference between treatment groups.

Conclusion

This analysis from the CONFIRM study demonstrated that the incidence of RRT in patients with HRS and fluid overload was lower in terli-treated patients compared with pbo-treated patients. Improved renal function with terli may lead to reduced RRT requirements in patients with HRS and fluid overload.

Funding

  • Commercial Support – Mallinckrodt Pharmaceuticals