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. 2025 Sep 8:S1542-3565(25)00751-7.
doi: 10.1016/j.cgh.2025.08.031. Online ahead of print.

Real-world Use of Terlipressin in Cirrhosis and Acute Kidney Injury: Frequent Use Beyond Hepatorenal Syndrome

Ann T Ma  1 , Adrià Juanola  2 , Kavish R Patidar  3 , Anna Barone  4 , Simone Incicco  4 , Anand V Kulkarni  5 , Nipun Verma  6 , Christian M Lange  7 , Qing Xie  8 , Carlo Alessandria  9 , Eira Cerda Reyes  10 , Rakhi Maiwall  11 , Jeong Han Kim  12 , Sebastián Marciano  13 , Alberto Queiroz Farias  14 , Claudio Toledo  15 , Silvia Nardelli  16 , Julio D Vorobioff  17 , Juan Pablo Roblero  18 , Thierry Thévenot  19 , Maria Papp  20 , Raoel Maan  21 , Cristina Solé  22 , Jacqueline Cordova-Gallardo  23 , Douglas A Simonetto  24 , Yasser Fouad  25 , Lorenz Balcar  26 , Sarah Raevens  27 , Puria Nabilou  28 , Paolo Caraceni  29 , Manuela Merli  30 , José Presa  31 , Wim Laleman  32 , Aleksander Krag  33 , Tony Bruns  34 , Gustavo Pereira  35 , Angelo Z Mattos  36 , Juan Pablo Arab  37 , Brian Wentworth  38 , Nadia Abdelaaty Abdelkader  39 , Yu Jun Wong  40 , Sung-Eun Kim  41 , Olivier Roux  42 , R Bart Takkenberg  43 , Antonio Galante  44 , Luciana Lofego Goncalves  45 , Nikolaos T Pyrsopoulos  46 , José Luis Pérez Hernández  47 , Sumeet K Asrani  48 , Aldo Torre  49 , Javier Díaz-Ferrer  50 , Eric S Orman  51 , Giovanni Perricone  52 , Adrian Gadano  13 , Vladimir Ivashkin  53 , Eduardo Fassio  54 , Mónica Marino  55 , Victor Vargas  56 , Liane Rabinowich  57 , Pedro Montes  58 , Abdulsemed Mohammed  59 , Enrique Carrera  60 , María Cecilia Cabrera  61 , Marcos Girala  62 , Hrishikesh Samant  63 , Joao Madaleno  64 , W Ray Kim  65 , Carlos Noronha Ferreira  66 , Andrew S Allegretti  67 , Shiv K Sarin  11 , Pere Ginès  2 , Paolo Angeli  4 , Elsa Solà  65 , Salvatore Piano  68 ; International Club of Ascites GLOBAL AKI team
Collaborators, Affiliations

Real-world Use of Terlipressin in Cirrhosis and Acute Kidney Injury: Frequent Use Beyond Hepatorenal Syndrome

Ann T Ma et al. Clin Gastroenterol Hepatol. .

Abstract

Background & aims: Terlipressin is indicated to treat hepatorenal syndrome (HRS)-acute kidney injury (AKI) but is likely used outside this primary indication in clinical practice. We aimed to investigate real-world practice patterns on the use of terlipressin in AKI in cirrhosis.

Methods: International prospective study including patients hospitalized for decompensated cirrhosis. This was a subgroup analysis of patients who received terlipressin to treat AKI. Primary outcome was AKI resolution. Secondary outcomes were respiratory failure and 28-day mortality.

Results: Among 1456 patients with AKI, 243 (17%) received terlipressin. Terlipressin was predominantly administered as a continuous infusion (75%). The AKI phenotype was HRS-AKI in 50%, acute tubular necrosis (ATN) in 17%, hypovolemic in 25%, and other in 8%. AKI resolution occurred in 49% of the patients, and was lowest in ATN (29%), followed by HRS-AKI (51%) and hypovolemic (63%). ATN was independently associated with lack of AKI resolution (odds ratio, 2.77; 95% confidence interval, 1.24-6.54; P = .02). De novo respiratory failure occurred in 20% of patients. There were no significant differences in the amount of albumin received nor acute-on-chronic liver failure grade between those who did and did not develop respiratory failure. The presence of pneumonia independently predicted respiratory failure (odds ratio, 7.80; 95% confidence interval, 2.43-26.95; P < .001). Mortality rate at 28 days was 36%; ATN and hospital-acquired AKI independently predicted 28-day mortality.

Conclusions: Terlipressin is often used for treatment of AKI outside its primary indication of HRS-AKI. Compared with patients with HRS-AKI, response to terlipressin is significantly lower in patients with ATN, in whom the risks may outweigh the benefits. Respiratory failure is common but does not seem to be driven by the amount of albumin received nor acute-on-chronic liver failure grade.

Keywords: Hepatorenal Syndrome; Mortality; Respiratory Failure; Vasoconstrictor.

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Conflict of interest statement

Conflicts of interest

These authors disclose the following: Kavish R. Patidar received advisory board fees from Madrigal Pharmaceuticals; and has received consulting fees from Mallinckrodt Pharmaceuticals. Christian M. Lange received speakers honoraria and advisory board fees from AbbVie, Gilead, Falk, Eisai, Norgine, CSL Behring, Boston Scientific, AstraZeneca, Shionogi, Roche, and Sobi. Maria Papp received funding from the Ministry of Innovation and Technology of Hungary from the National Research, Development, and Innovation Fund. Douglas A. Simonetto consulted for Mallinckrodt, BioVie, Evive, Resolution Therapeutics, PharmaIN, AstraZeneca, and Iota. Puria Nabilou received research grants from Novo Nordisk and Takeda Pharma. Paolo Caraceni received speaking fees from Grifols SA, Octapharma SA, and CSL Behring SA; research grants from Grifols SA and Octapharma SA; and advisory board fees from CSL Behring. Manuela Merli received speaker honoraria from Gore. Aleksander Krag has served as speaker for Novo Nordisk, Norgine, Siemens, and Nordic Bioscience; participated in advisory boards for Norgine, Siemens, Resalis Therapeutics, Boehringer Ingelheim, and Novo Nordisk, all outside the submitted work; received research support from Norgine, Siemens, Nordic Bioscience, Astra, and Echosense; and is a board member and co-founder of Evido. Tony Bruns received speaking fees, consulting fees, or travel support from Abbvie, Gilead, SOBI, CSL Behring, Merck, Gore, and Advanz. Brian Wentworth received advisory board and consulting fees from Ipsen; and consulting fees from GSK and Luna Labs USA. Yu Jun Wong received speaking fees from Gilead and AbbVie. Nikolaos T. Pyrsopoulos received research grants from Salix, OCERA, Grifols, CytoSorbents, Intercept, and Gilead; speaking fees from Ipsen and Madrigal; and advisory board fees from Salix, Ipsen, and OCERA. Andrew S. Allegretti has received consulting fees from Mallinckrodt Pharmaceuticals, Ocelot Bio, Sequana Medical, Bioporto, and Motric Bio. Pere Ginés received research funding from Gilead and Grifols; has consulted or attended advisory boards for Gilead, RallyBio, SeaBeLife, Merck, Sharp and Dohme (MSD), Ocelot Bio, Behring, Roche Diagnostics International, Boehringer Ingelheim, and Astra-Zeneca; and has received speaking fees from Pfizer. Paolo Angeli received grant/research support from Grifols and CSL Behring; held a patent with Biovie; and served as consultant for Sequana Medical. Salvatore Piano served as consultant for Plasma Protein Therapeutics Association, Boehringer Ingelheim, and Resolution Therapeutics; and received speaking fees from Grifols, Ferring, and Medscape. The remaining authors disclose no conflicts.

Figures

Figure 1.
Figure 1.
Cumulative incidence of death in terlipressin-treated patients by AKI phenotype, in the subgroup of patients with either ATN or HRS-AKI. Including 164 patients (41 with ATN, 123 with HRS-AKI). The 28-day cumulative incidence of death for ATN was 0.53 (95% CI, 0.36–0.67) and for HRS-AKI 0.39 (95% CI, 0.30–0.49); Gray test P value = .051. The shaded area represents 95% CI.
See this image and copyright information in PMC

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