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Terlipressin for hepatorenal syndrome

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Abstract

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Background

Terlipressin may reverse some of the circulatory changes associated with hepatorenal syndrome.

Objectives

To assess the beneficial and harmful effects of terlipressin for hepatorenal syndrome.

Search methods

Electronic searches in The Cochrane Hepato‐Biliary Group Controlled Trials Register, The Cochrane Renal Group Register, the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, and EMBASE were combined with scanning of bibliographies and conference proceedings, and correspondence with experts and pharmaceutical companies. Last search update was July 2006.

Selection criteria

Randomised clinical trials were included irrespective of dose or treatment duration. Included patients had type 1 or type 2 hepatorenal syndrome. Co‐interventions were allowed if administered equally to both treatment and control groups.

Data collection and analysis

Data were retrieved from trial reports and correspondence with the authors of included trials. Mortality was the primary outcome. Meta‐analyses were performed to calculate risk differences (RD) for binary outcomes and weighted mean differences (WMD) for continuous outcomes. Both were presented with 95% confidence intervals (CI). Due to the limited number of trials, no subgroup analyses were performed.

Main results

The initial searches identified 645 potentially relevant references. Six randomised trials were eligible for inclusion. Three trials are still ongoing. Three trials with a total of 51 patients assessed terlipressin 1 mg bid for 2 to 15 days. Co‐interventions included albumin, fresh frozen plasma, and cimetidine 800 mg daily. One trial reported adequate bias control assessed by randomisation and blinding. All trials reported mortality. Terlipressin reduced mortality rates by 34% (RD ‐0.34, 95% CI ‐0.56 to ‐0.12). The control group mortality rate was 65%. Terlipressin improved renal function assessed by creatinine clearance (WMD 21 ml/min, 95% CI 17 to 26), serum creatinine (WMD ‐219 micromol/l, 95% CI ‐244 to ‐194), and urine output (WMD 707 ml/day, 95% CI ‐212 to 1625). Adverse events included headache, abdominal pain, cardiac arrhythmia, and hypertension.

Authors' conclusions

Additional evidence on terlipressin for hepatorenal syndrome is needed before reliable treatment recommendations can be made. The dose and duration of therapy, and the influence of co‐interventions remain to be established.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

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Promising, but no definite evidence on terlipressin for hepatorenal syndrome

The present review suggests that terlipressin may reduce mortality and improve renal function in hepatorenal syndrome. A number of co‐interventions including albumin and fresh frozen plasma may be important to achieve these effects. However, due to the small sample size and risk of bias in the included trials, making treatment recommendations is not possible. Larger randomised trials with adequate bias control are needed before definite conclusions can be made.