Noradrenaline vs. terlipressin in the treatment of hepatorenal syndrome: A randomized study

Singh, Virendra; Ghosh, Souvik; Singh, Baljinder; Kumar, Pradeep; Sharma, Navneet; Bhalla, Ashish; Sharma, Arun; Choudhary, Narendra S.; Chawla, Yogesh; Nain, C. K.

doi:10.1016/j.jhep.2012.01.012

Cited by 224 publications

(184 citation statements)

References 30 publications

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“…Our observations regarding factors predictive of HRS reversal and survival essentially confirm what has been observed in previous studies,22, 23, 24, 25, 26, 27 with the exception of the absence of a precipitating cause for HRS‐1, absence of prior rifaximin use in the terlipressin group, and male sex in the placebo group – all new observations. The absence of prior rifaximin use as a factor predictive of HRS reversal in the terlipressin group is of interest; it is possible that patients without prior rifaximin exposure are less ill than those receiving rifaximin.…”

Section: Discussionsupporting

confidence: 89%

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: Discussionsupporting

confidence: 89%

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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“…A case-control study revealed that the regimen of octreotide, midodrine, and albumin significantly improved short-term survival and renal function in both type 1 and type 2 HRS [185]. In addition, RCTs showed that norepinephrine is as safe and effective as terlipressin, but is less expensive in the treatment of type 1 and type 2 HRS [186][187][188]. Norepinephrine and albumin are proposed because norepinephrine is the only drug approved by the National Health Insurance in Japan.…”

Section: Cq: Is Albumin Infusion Effective For Treatment Of Cirrhoticmentioning

confidence: 99%

Evidence-based clinical practice guidelines for liver cirrhosis 2015

et al. 2016

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The Japanese Society of Gastroenterology revised the evidence-based clinical practice guidelines for liver cirrhosis in 2015. Eighty-three clinical questions were selected, and a literature search was performed for the clinical questions with use of the MEDLINE, Cochrane, and Igaku Chuo Zasshi databases for the period between 1983 and June 2012. Manual searching of the latest important literature was added until August 2015. The guidelines were developed with use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. This digest version in English introduces selected clinical questions and statements related to the management of liver cirrhosis and its complications. Branched-chain amino acids relieve hypoalbuminemia and hepatic encephalopathy and improve quality of life. Nucleoside analogues and peginterferon plus ribavirin combination therapy improve the prognosis of patients with hepatitis B virus related liver cirrhosis and hepatitis C related compensated liver cirrhosis, respectively, although the latter therapy may be replaced by direct-acting antivirals. For liver cirrhosis caused by primary biliary cirrhosis and active autoimmune hepatitis, urosodeoxycholic acid and steroid are recommended, respectively. The most adequate modalities for the management of variceal bleeding are the endoscopic injection sclerotherapy for esophageal varices and the balloon-occluded retrograde transvenous obliteration following endoscopic obturation with cyanoacrylate for gastric varices. Beta-blockers are useful for primary prophylaxis of esophageal variceal bleeding. The V 2 receptor antagonist tolvaptan is a useful add-on therapy in careful diuretic therapy for ascites. Albumin infusion is useful for the prevention of paracentesis-induced circulatory disturbance and renal failure. In addition to disaccharides, the nonabsorbable antibiotic rifaximin is useful for the management of encephalopathy. Anticoagulation therapy is proposed for patients with acute-onset or progressive portal vein thrombosis.

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“…on day 1, followed by 20-40 g/day according to the central venous pressure and/or evidence of volume overload until terlipressin is stopped 52,53 . A few studies have evaluated other vasoconstrictors for the management of type 1 HRS, such as noradrenaline, which showed a similar efficacy as terlipressin 60,61 , and midodrine plus octreotide, a combination that was less effective than terlipressin 62 . With both treatment approaches, HA is given at the doses described for use with terlipressin [60][61][62] .…”

Section: Albumin For the Treatment Of Type 1 Hepatorenalmentioning

confidence: 99%

“…A few studies have evaluated other vasoconstrictors for the management of type 1 HRS, such as noradrenaline, which showed a similar efficacy as terlipressin 60,61 , and midodrine plus octreotide, a combination that was less effective than terlipressin 62 . With both treatment approaches, HA is given at the doses described for use with terlipressin [60][61][62] . Information on the use of vasoconstrictors plus HA in patients with type 2 HRS is really limited.…”

Section: Albumin For the Treatment Of Type 1 Hepatorenalmentioning

confidence: 99%

AISF-SIMTI Position Paper: The appropriate use of albumin in patients with liver cirrhosis

Caraceni¹,

Angeli²,

Prati³

et al. 2016

Digestive and Liver Disease

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Noradrenaline vs. terlipressin in the treatment of hepatorenal syndrome: A randomized study

Cited by 224 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

Evidence-based clinical practice guidelines for liver cirrhosis 2015

AISF-SIMTI Position Paper: The appropriate use of albumin in patients with liver cirrhosis

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