Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 0.85 mg/vial) |
Drug Class | Vasopressin 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
- 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 Title | Year | Source |
---|---|---|
Terlivaz (terlipressin) Prescribing Information. | 2023 | Mallinckrodt Hospital Products Inc., Bedminster, NJ |