Terlipressin

(Terlivaz®)

Terlivaz®

Drug updated on 12/11/2024

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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  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Hepatorenal syndrome causing acute kidney injury (HRS-AKI) Reversal and Short-term Survival (Meta-analysis of 7 randomized control trial (RCTs), 376 subjects): Terlipressin showed higher rates of HRS reversal (odds ratio (OR) 1.33, 95% confidence interval (CI) [0.80-2.22]; p = 0.22) and short-term survival (OR 1.50, 95% CI [0.64-3.53]; p = 0.26) compared to norepinephrine, though results were not statistically significant.
  • AKI in Perioperative Transplant Period (Systematic Review of 9 studies, 711 patients): Terlipressin reduced AKI risk (0.6 [95% CI, 0.44-0.8]; p = 0.001), but this was not significant in sensitivity analysis (0.7 [0.43-1.09]; p = 0.11). Other outcomes, such as mortality and duration of hospital stay, showed no significant differences.
  • Septic Shock (Systematic Review of 9 studies, 850 participants): No significant difference in overall mortality (relative risk (RR) 0.85 [0.70-1.03]; p = 0.09), but terlipressin reduced mortality in patients younger than 60 years (RR 0.66 [0.50-0.86]; p = 0.002).
  • In a meta-analysis of 7 RCTs for HRS-AKI, serious adverse events leading to discontinuation occurred in 5.3% of patients receiving terlipressin compared to 2.7% of those on norepinephrine. Common adverse events included abdominal pain and diarrhea for terlipressin, while norepinephrine was associated with cardiovascular events such as chest pain and ischemia.
  • In a systematic review of septic shock studies, there was no significant difference in total adverse events between terlipressin and other drugs (OR 1.48 [0.51-4.24]; p = 0.47), though terlipressin was linked to a higher occurrence of peripheral ischemia (OR 8.65 [1.48-50.59]; p = 0.02).
  • There is no population types or subgroups information available in the reviewed documents.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses