- Terlipressin plus albumin is associated with greater improvement in renal function compared with albumin alone in patients with hepatorenal syndrome type 1 (HRS-1).
Why this matters
- There is a need for pharmacologic approaches to reverse HRS and improve renal function in patients with HRS.
- Patients with HRS-1 were randomly assigned to albumin plus intravenous terlipressin 1 mg every 6 hours (n=199) or albumin plus placebo (n=101).
- Treatment continued to day 14 until achievement of verified HRS reversal (VHRSR), renal replacement therapy (RRT), liver transplantation (LT), or serum creatinine (SCr) at or above baseline.
- Primary endpoint: VHRSR (i.e., a total of 2 consecutive SCr values ≤1.5 mg/dL, ≥2 hours apart, in patients alive without RRT for ≥10 days following second SCr ≤1.5 mg/dL).
- Funding: None reported.
- VHRSR was achieved in 29.1% of patients in the terlipressin group vs 15.8% in the placebo group (P<.012>
- A significantly greater proportion of patients meeting systemic inflammatory response syndrome (SIRS) criteria achieved VHRSR if they were assigned terlipressin (33.3% vs 6.3%; P<.001>
- Serious adverse events were reported in 65% of patients assigned terlipressin vs 60.6% assigned placebo.
- Only a small number of patients met SIRS criteria.