Condition
Hepatorenal Syndrome
Hepatorenal syndrome is a serious loss of kidney function in advanced liver disease, driven by altered blood flow to the kidneys rather than direct kidney damage. Terlipressin, a prescription drug, has the strongest evidence: in a 300-person phase 3 trial, the syndrome resolved in 32% of people on it versus 17% on placebo. Most people on the drug still did not recover in that trial.
Sources: PMID 40207491
- Updated
- How we grade
- 12 studies cited
- Supplements studied
- 0
- Medicines and peptides
- 1
- Graded outcomes
- 4
Prescription medicines and peptides studied, for context
| Grade | Outcome | Effect | Size | Studies | People | Studies list |
|---|---|---|---|---|---|---|
| HRS Reversal (Pooled Analysis) Pooled OT-0401 + REVERSE trials (n=308): HRS reversal 27% terlipressin vs 14% placebo (P=0.004). Mean serum creatinine difference -53.0 umol/L favoring terlipressin (P<0.0001). Consistent effect across both trials. | Improves (the measure goes up) | Large effect | 12 studies | |||
Studies that measured hrs reversal (pooled analysis)
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| HRS Reversal (CONFIRM Trial) CONFIRM Phase 3 trial (n=300): Verified HRS reversal achieved in 32% terlipressin vs 17% placebo (P=0.012). Led to FDA approval. Mean serum creatinine improvement significantly greater with terlipressin. Effects maintained through study duration. | Improves (the measure goes up) | Large effect | 9 studies | |||
Studies that measured hrs reversal (confirm trial)
| ||||||
| Serum Creatinine Improvement CONFIRM trial: Significant improvement in renal function with terlipressin vs placebo. 29% achieved kidney function improvement vs 16% placebo. Early treatment (<48h from diagnosis) associated with better outcomes. | Improves (the measure goes up) | Moderate effect | 7 studies | |||
Studies that measured serum creatinine improvement
| ||||||
| Respiratory Failure Risk SAFETY CONCERN: CONFIRM trial showed increased serious respiratory adverse events with terlipressin. Black box warning: Risk of respiratory failure. Avoid use if oxygen saturation <90%. Higher risk in ACLF grade 3 patients. Patients with SCr >5 mg/dL unlikely to benefit. | Worsens (the measure goes up) | Moderate effect | 7 studies | |||
Studies that measured respiratory failure risk
| ||||||
Key findings
- HRS Reversal (Pooled Analysis)Improves (the measure goes up)
- HRS Reversal (CONFIRM Trial)Improves (the measure goes up)
- Serum Creatinine ImprovementImproves (the measure goes up)
Safety notes in the studies
- SAFETY CONCERN: CONFIRM trial showed increased serious respiratory adverse events with terlipressin.
- Black box warning: Risk of respiratory failure.
- Avoid use if oxygen saturation <90%.
Studies cited
12 studies from PubMed
- Terlipressin for the treatment of hepatorenal syndrome: a meta-analysis of randomized controlled trials.
- Multisystem hemodynamic effects of terlipressin in cirrhosis: A scoping review.
- Comparative efficacy of terlipressin and norepinephrine for treatment of hepatorenal syndrome-acute kidney injury: A systematic review and meta-analysis.
- Early treatment with terlipressin in patients with hepatorenal syndrome yields improved clinical outcomes in North American studies
- Terlipressin and the Treatment of Hepatorenal Syndrome: How the CONFIRM Trial Moves the Story Forward
- Effectiveness of Terlipressin on Modulation of Portal Vein Pressure after Hepatic Resections in Non-Cirrhotic Patients. A Systematic Review and Meta-Analysis of Randomised Controlled Trials.
- Role of Terlipressin in Cirrhotic Patients with Ascites and without Hepatorenal Syndrome: A Systematic Review of Current Evidence.
- Terlipressin in the treatment of hepatorenal syndrome: A systematic review and meta-analysis.
- Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the OT-0401 and REVERSE randomised clinical studies
- Terlipressin versus noradrenaline in the treatment of hepatorenal syndrome: systematic review with meta-analysis and full economic evaluation.
- Pharmacology, clinical efficacy and safety of terlipressin in esophageal varices bleeding, septic shock and hepatorenal syndrome
- A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome