Terlipressin

(Terlivaz®)

Terlipressin

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 0.85 mg/vial)
Drug ClassVasopressin receptor agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

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Summary
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  • Terlivaz (terlipressin) is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • HRS Reversal Rates: Terlipressin showed a numerically higher but not statistically significant increase in HRS reversal rates compared to noradrenaline (RR = 1.15 [0.96, 1.37]) and placebo. However, pooled reversal rates were not significantly improved over time, with a rate of 42.8% (95% CI 34.2-51.9).
  • Mortality Rates: No significant difference in mortality between terlipressin and noradrenaline (RR = 0.87 [0.74, 1.01]). Terlipressin may reduce mortality compared to placebo with low certainty, while pooled survival rates remained at 34.6% (95% CI 26.4-43.8).
  • Renal Function and Hemodynamics: Terlipressin improved renal function and hemodynamics in patients with cirrhosis and ascites without HRS, and showed effectiveness over albumin alone or in combination with midodrine and octreotide. However, no significant differences were observed in key renal parameters in other studies.
  • Terlipressin is associated with a higher risk of serious adverse events compared to placebo (moderate certainty) and has a higher discontinuation rate due to serious adverse events (5.3%) compared to noradrenaline (2.7%).
  • Noradrenaline generally has fewer serious adverse events compared to terlipressin, and albumin plus noradrenaline was reported to have fewer adverse events per participant than albumin plus terlipressin.
  • The evidence primarily involves adults with hepatorenal syndrome (HRS) and cirrhosis, including perioperative liver transplant patients. The findings indicate no significant differences in effectiveness outcomes between terlipressin and noradrenaline across these subgroups, and terlipressin therapy does not significantly benefit perioperative liver transplant patients regarding post-transplant AKI or the need for renal replacement therapy.

Product Monograph / Prescribing Information

Document TitleYearSource
Terlivaz (terlipressin) Prescribing Information. 2023Mallinckrodt Hospital Products Inc., Bedminster, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of terlipressin and albumin vs. noradrenaline and albumin in adult patients with hepatorenal syndrome: a systematic review and meta-analysis.2024Annals of Hepatology
Comparative efficacy of terlipressin and norepinephrine for treatment of hepatorenal syndrome-acute kidney injury: a systematic review and meta-analysis.2024PLoS
A comprehensive systematic review of the latest management strategies for hepatorenal syndrome: a complicated syndrome to tackle. 2023Cureus
A systematic review of the emerging treatment for hepatorenal syndrome with a principal focus on terlipressin: a recent FDA-approved drug. 2023Cureus
Prophylactic perioperative terlipressin therapy for preventing acute kidney injury in living donor liver transplant recipients: a systematic review and meta-analysis.2022Journal of Clinical and Experimental Hepatology
The comparative effectiveness of vasoactive treatments for hepatorenal syndrome: a systematic review and network meta-analysis.2022Critical Care Medicine
Limited progress in hepatorenal syndrome (HRS) reversal and survival 2002-2018: a systematic review and meta-analysis.2020Digestive Diseases and Sciences
Role of terlipressin in cirrhotic patients with ascites and without hepatorenal syndrome: a systematic review of current evidence.2020Canadian Journal of Gastroenterology & Hepatology
Treatment for hepatorenal syndrome in people with decompensated liver cirrhosis: a network meta-analysis.2019Cochrane Database of Systematic Reviews