6/28/23, 12:16 AM CONFIRM Pathway Feedback Search Clinical Topics Home Studies CONFIRM CONFIRM Disease Hepatorenal syndrome Trial question What is the role of terlipressin in patients with type 1 hepatorenal syndrome? Study design Multi-center Double blinded RCT Population Characteristics of study participants 40.0% female N = 300 60.0% male 300 patients (121 female, 179 male) Inclusion criteria: adult patients with type 1 hepatorenal syndrome Key exclusion criteria: serum creatinine level > 7.0 mg/dL; 1 large-volume paracenteses of 4 L within 2 days before randomization; sepsis or uncontrolled bacterial infection for which antibiotic treatment was administered for < 2 days Interventions N=199 terlipressin (intravenous bolus injection of terlipressin plus albumin) N=101 placebo (matching placebo solution for injection plus albumin) Primary outcome Verified reversal of hepatorenal syndrome 32.0 % 32 24.0 % https://web.pathway.md/studies/rechnX8jfKVuaoedx 1/2 6/28/23, 12:16 AM CONFIRM Pathway 17 16.0 % Significant increase 8.0 % NNT = 7 0.0 % Terlipressin Placebo Significant increase in verified reversal of hepatorenal syndrome (32% vs. 17%; AD 15%, 95% CI 4.31 to 25.69) Secondary outcomes Significant increase in hepatorenal syndrome reversal (39% vs. 18%; AD 21%, 95% CI 8.54 to 33.46) Significant increase in the rate of hepatorenal syndrome reversal with no RRT through day 30 (34% vs. 17%; AD 17%, 95% CI 6.91 to 27.09) Significant increase in hepatorenal syndrome reversal in patients with systemic inflammatory response syndrome (37% vs. 6%; AD 31%, 95% CI 12.61 to 49.39) Safety outcomes No significant difference in adverse events. Significant differences in adverse events leading to discontinuation of trial regimen (12% vs. 5%), respiratory failure (10% vs. 3%). Conclusion In adult patients with type 1 hepatorenal syndrome, terlipressin was superior to placebo with respect to verified reversal of hepatorenal syndrome. Reference Florence Wong, S Chris Pappas, Michael P Curry et al. Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome. N Engl J Med. 2021 Mar 4;384(9):818-828. Open reference URL https://web.pathway.md/studies/rechnX8jfKVuaoedx 2/2