Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1

Boyer, Thomas D.; Sanyal, Arun J.; Wong, Florence; Frederick, Richard; Lake, John R.; O’Leary, Jacqueline G.; Ganger, Daniel; Jamil, Khurram; Pappas, S. Chris; Sigal, Samuel H.; Muñoz, Santiago J.; Patel, Vishal C.; Kwo, Paul Y.; Bajaj, Jasmohan S.; Hassanein, Tarek; Shetty, Kirti; Satoskar, Rohit; Reddy, K. Rajender; Mayo, Marlyn J.; Araya, Víctor; Hashemi, Nikroo; Feyssa, Eyob; Rossaro, Lorenzo; Kravetz, David; Grewal, Priya; Subramanian, Ram; Korenblat, Kevin; Genyk, Yuri; Buell, Joseph F.; Shores, Nathan J.; Emre, Sükrü; Duchini, Andrea; Zaman, Atif; Olivera‐Martinez, Marco; Porayko, Michael K.; Befeler, Alex S.; Reddy, K. Gautham; Hernández, M.; Zucker, Stephen D.; Vargas, Hugo E.; Curry, Michael P.; Said, Adnan; Kowdley, Kris V.; Box, Terry; Barnes, David S.; Pepin, M.N.; Rudraraju, Madhavi; Angulo, Paul; Monsour, Howard Paul; Wolf, David S.; Howell, Charles D.; Regenstein, Fredric; Sánchez, Antonio; Elbeshbeshy, Hany; Fallon, Michael B.; Swales, Colin; Sass, David A.; Sotil, Eva U.; McGuire, Brendan M.; Gilroy, Richard; Guerrero, Juan A.; Wong, Mark; Shaikh, Obaid S.; Gonzalez, S. Tobia; Kayali, Zeid

doi:10.1053/j.gastro.2016.02.026

Cited by 236 publications

(245 citation statements)

References 30 publications

(49 reference statements)

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“…Details regarding the observed safety profiles for each individual study have been previously reported 16, 19. Overall, the incidence of adverse events was similar in the two treatment groups [terlipressin, 142/149 (95%); placebo, 137/150 (91%)], as was the incidence of serious adverse events [terlipressin, 96/149 (64%); placebo, 89/150 (59%)].…”

Section: Resultsmentioning

confidence: 68%

“…Low patient numbers restricted prior studies in their ability to explore multiple predictive factors. Use of our larger pooled database, derived from individual patient data, demonstrates the value of such pooling to explore and identify previously unreported factors that may be important in predicting therapeutic response and survival in patients with HRS‐116, 19 and which require further study.…”

Section: Discussionmentioning

confidence: 99%

“…The study designs, including eligibility criteria, procedures, treatments and statistical analyses, have been reported previously 11, 16, 19…”

Section: Methodsmentioning

confidence: 99%

“…OT‐0401 was conducted at 35 medical centres across the USA ( n = 30), Germany ( n = 2) and Russia ( n = 3) from June 2004 through September 2006 19. REVERSE was conducted at 52 medical centres in the USA ( n = 50) and Canada ( n = 2) during October 2010 through February 201316; eligible patients were randomised (1:1) to receive terlipressin or placebo, stratified by presence or absence of alcoholic hepatitis (see Supporting Information for a complete list of the OT‐0401 and REVERSE investigators). REVERSE also stratified patients by SCr <318 μmol/L or ≥318 μmol/L, based on the identification of lower baseline SCr as a predictor of HRS reversal and survival observed in the OT‐0401 study.…”

Section: Methodsmentioning

confidence: 99%

“…Terlipressin is a synthetic vasopressin analogue that produces systemic vasoconstriction through its V 1 receptor agonist activity 11. In several small, randomised, controlled studies, terlipressin treatment was shown to improve renal function in patients with HRS‐1 by significantly reducing SCr 12, 13, 14, 15, 16. Meta‐analyses of these studies of terlipressin in HRS‐1 support the beneficial effect of terlipressin on renal function 17, 18…”

Section: Introductionmentioning

confidence: 96%

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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

Sanyal

Boyer

Frederick

et al. 2017

Aliment Pharmacol Ther

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SummaryBackgroundThe goal of hepatorenal syndrome type 1 (HRS‐1) treatment is to improve renal function. Terlipressin, a synthetic vasopressin analogue, is a systemic vasoconstrictor used for the treatment of HRS‐1, where it is available.AimTo compare the efficacy of terlipressin plus albumin vs. placebo plus albumin in patients with HRS‐1.MethodsPooled patient‐level data from two large phase 3, randomised, placebo‐controlled studies were analysed for HRS reversal [serum creatinine (SCr) value ≤133 μmol/L], 90‐day survival, need for renal replacement therapy and predictors of HRS reversal. Patients received intravenous terlipressin 1–2 mg every 6 hours plus albumin or placebo plus albumin up to 14 days.ResultsThe pooled analysis comprised 308 patients (terlipressin: n = 153; placebo: n = 155). HRS reversal was significantly more frequent with terlipressin vs. placebo (27% vs. 14%; P = 0.004). Terlipressin was associated with a more significant improvement in renal function from baseline until end of treatment, with a mean between‐group difference in SCr concentration of −53.0 μmol/L (P < 0.0001). Lower SCr, lower mean arterial pressure and lower total bilirubin and absence of known precipitating factors for HRS were independent predictors of HRS reversal and longer survival in terlipressin‐treated patients.ConclusionsTerlipressin plus albumin resulted in a significantly higher rate of HRS reversal vs. albumin alone in patients with HRS‐1. Terlipressin treatment is associated with improved renal function. (ClinicalTrials.gov identifier: OT‐0401, NCT00089570; REVERSE, NCT01143246).

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Section: Resultsmentioning

confidence: 68%

Section: Discussionmentioning

confidence: 99%

“…The study designs, including eligibility criteria, procedures, treatments and statistical analyses, have been reported previously 11, 16, 19…”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

See 3 more Smart Citations

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

Sanyal

Boyer

Frederick

et al. 2017

Aliment Pharmacol Ther

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Plasma expanders for people with cirrhosis and large ascites treated with abdominal paracentesis

Simonetti

Nikolova

Bjelaković

et al. 2019

Cochrane Database of Systematic Reviews

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Terlipressin versus placebo or no intervention for people with cirrhosis and hepatorenal syndrome

Allegretti

Israelsen

Krag

et al. 2017

Cochrane Database of Systematic Reviews

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Review question Is terlipressin better than inactive placebo/no treatment for people with hepatorenal syndrome? Search date November 2016. Study characteristics The review includes nine randomised clinical trials (RCTs) and a total of 534 participants. The trials originated from six countries. Seven trials included only participants with type 1 hepatorenal syndrome. Two trials included a total of 96 participants with type 1 or type 2 hepatorenal syndrome. Study funding sources Three RCTs reported funding from a pharmaceutical company. The remaining trials did not report funding or did not receive funding from pharmaceutical companies. Key results 2 Terlipressin versus placebo or no intervention for people with cirrhosis and hepatorenal syndrome (Review)

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Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1

Abstract: Terlipressin plus albumin was associated with greater improvement in renal function vs albumin alone in patients with cirrhosis and HRS-1. Patients had similar rates of HRS reversal with terlipressin as they did with albumin. ClinicalTrials.gov no: NCT01143246.

Cited by 236 publications

References 30 publications

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

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

Plasma expanders for people with cirrhosis and large ascites treated with abdominal paracentesis

Terlipressin versus placebo or no intervention for people with cirrhosis and hepatorenal syndrome

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