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Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study.

Authors » Ghosh S , Choudhary NS , Sharma AK , Singh B , Kumar P , Agarwal R , Sharma N , Bhalla A , Chawla YK , Singh V

Journal » Liver international : official journal of the International Association for the Study of the Liver

Year » 2013

Links » Pubmed Health Technology Assessment (HTA) DOI crd.york.ac.uk

This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however, it is costly and not available in some countries. In this study, we evaluated the safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS. METHODS: Forty-six patients with type 2 HRS were managed with terlipressin (group A, N = 23) or noradrenaline (Group B, N = 23) with albumin in a randomized controlled trial at a tertiary centre. RESULTS: HRS reversal could be achieved in 17(73.9%) patients in group A as well as in group B (P = 1.0). Univariate analysis showed that the baseline model of end-stage liver disease score, urine output, urinary sodium, serum creatinine and mean arterial pressure were associated with response. However, in multivariate analysis only baseline serum creatinine, urine output and urinary sodium were associated with the response. Eight patients in group A and 9 in group B died within 90 days of follow-up (P > 0.05). Noradrenaline was less expensive than terlipressin (P < 0.05). No major adverse effects were seen. CONCLUSIONS: The results of this randomized study suggest that terlipressin and noradrenaline are safe and effective in the treatment of type 2 HRS and baseline serum creatinine, urine output and urinary sodium are predictive of response. Noradrenaline is less expensive than terlipressin in the treatment of type 2 HRS (ClinicalTrials.gov, Number NCT01637454).

Singh V et al [2012]

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An open label, pilot, randomized controlled trial of noradrenaline versus terlipressin in the treatment of type 1 hepatorenal syndrome and predictors of response

Authors » Sharma P , Kumar A , Shrama BC , Sarin SK

Journal » The American journal of gastroenterology

Year » 2008

Links » Pubmed DOI

This article is included in 7 Systematic reviews Systematic reviews (7 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND Hepatorenal syndrome (HRS) is characterized by functional renal failure in end-stage liver disease.ANDAIMS: Terlipressin is the drug of choice for treating type 1 HRS (HRS-1). It is expensive and often not readily available. We, in an open label, randomized, pilot trial, compared the efficacy of terlipressin and noradrenaline on the renal functions and clinical outcome of patients with HRS-1 and also sought predictors of response.PATIENTSAND Forty consecutive patients with HRS-1 were randomized to receive noradrenaline 0.5-3.0 mg/h andMETHODS: albumin (group A, N = 20) or terlipressin 0.5-2 mg, 6 hourly and albumin (group B, N = 20), until reversal of HRS (primary end point) or completion of 15 days of therapy (secondary end point). Systemic and renal parameters were monitored. Baseline parameters and delta creatinine at day 4 (DCD4) were used to predict response.RESULTS: The two groups were comparable at baseline. At similar time points, 10 (50%) patients in each group achieved primary end points. Patients in both groups had a significant (P < 0.05) decrease in serum creatinine from baseline (group A day 4 2.4 ± 1.2 mg/dL, day 8 1.6 ± 1.2 mg/dL, and day 15 1.0 ± 0.4 mg/dL; group B day 4 2.5 ± 1.5 mg/dL, day 8 1.8 ± 0.9 mg/dL, and day 15 1.2 ± 0.5 mg/dL) and progressive increase in creatinine clearance (group A day 4 26.5 ± 12.8 mL/min and day 15 59.8 ± 14.2 mL/min; group B day 4 31.4 ± 21.4 mL/min and day 15 54.9 ± 27.5 mL/min, P < 0.05). Median baseline plasma renin activity was reduced from 38.0 and 42.0 ng/mL/h to 3.0 and 8.0 ng/mL/h (P = 0.08) in groups A and B, respectively. Mean arterial BP and urine output significantly increased in both groups with therapy. Eleven (55%) patients in group A (10 responders) and an equal number in group B (8 responders) survived until day 15 (P = 0.798). Reversible cardiac ischemia was seen in one patient in each group. Noradrenaline therapy was significantly less expensive than terlipressin. On univariate analysis, the following baseline parameters predicted response to therapy: lower grade of encephalopathy, lower MELD score, higher creatinine clearance, higher mean arterial pressure (MAP), and lower plasma renin activity. However, on multivariate analysis only baseline creatinine clearance, MAP, and plasma renin activity were independent predictors of response. At day 4 of therapy, DCD4 was computed and a value of 0.15 mg/dL/day or more accurately predicted response. The sensitivity, specificity, positive predictive value, and negative predictive value for DCD4 0.15 mg/dL/day for predicting response to therapy were 90%, 75%, 78%, and 88%, respectively.CONCLUSIONS: Noradrenaline may be an effective and safe alternative to terlipressin in improving renal functions. Various baseline parameters and DCD4 can be used to predict response to therapy. © 2008 by Am. Coll. of Gastroenterology Published by Blackwell Publishing.

University of Turin, Italy, Alessandria C

This thread includes 2 references

BACKGROUND:

Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however, it is costly and not available in some countries. In this study, we evaluated the safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS.

METHODS:

Forty-six patients with type 2 HRS were managed with terlipressin (group A, N = 23) or noradrenaline (Group B, N = 23) with albumin in a randomized controlled trial at a tertiary centre.

RESULTS:

HRS reversal could be achieved in 17(73.9%) patients in group A as well as in group B (P = 1.0). Univariate analysis showed that the baseline model of end-stage liver disease score, urine output, urinary sodium, serum creatinine and mean arterial pressure were associated with response. However, in multivariate analysis only baseline serum creatinine, urine output and urinary sodium were associated with the response. Eight patients in group A and 9 in group B died within 90 days of follow-up (P > 0.05). Noradrenaline was less expensive than terlipressin (P < 0.05). No major adverse effects were seen.

CONCLUSIONS:

The results of this randomized study suggest that terlipressin and noradrenaline are safe and effective in the treatment of type 2 HRS and baseline serum creatinine, urine output and urinary sodium are predictive of response. Noradrenaline is less expensive than terlipressin in the treatment of type 2 HRS (ClinicalTrials.gov, Number NCT01637454).

Study Design » Randomized controlled trial (RCT)

Country » India

Primary studies included in this systematic review