CONFIRM (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
60.0% male
N = 300
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%
17%
32.0 %
24.0 %
16.0 %
8.0 %
0.0 %
Terlipressin
Placebo
Significant
increase ▲
NNT = 6
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.
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