Gastroenterology

Gastroenterology

Volume 134, Issue 5, May 2008, Pages 1352-1359
Gastroenterology

Clinical–Liver, Pancreas, and Biliary Tract
Terlipressin and Albumin vs Albumin in Patients With Cirrhosis and Hepatorenal Syndrome: A Randomized Study

https://doi.org/10.1053/j.gastro.2008.02.024Get rights and content

Background & Aims: Hepatorenal syndrome is common in patients with advanced cirrhosis and constitutes a major problem in liver transplantation. There is no effective medical treatment for hepatorenal syndrome. Methods: Forty-six patients with cirrhosis and hepatorenal syndrome, hospitalized in a tertiary care center, were randomly assigned to receive either terlipressin (1–2 mg/4 hour, intravenously), a vasopressin analogue, and albumin (1 g/kg followed by 20–40 g/day) (n = 23) or albumin alone (n = 23) for a maximum of 15 days. Primary outcomes were improvement of renal function and survival at 3 months. Results: Improvement of renal function occurred in 10 patients (43.5%) treated with terlipressin and albumin compared with 2 patients (8.7%) treated with albumin alone (P = .017). Independent predictive factors of improvement of renal function were baseline urine volume, serum creatinine and leukocyte count, and treatment with terlipressin and albumin. Survival at 3 months was not significantly different between the 2 groups (terlipressin and albumin: 27% vs albumin 19%, P = .7). Independent predictive factors of 3-month survival were baseline model for end-stage liver disease score and improvement of renal function. Cardiovascular complications occurred in 4 patients treated with albumin alone and in 10 patients treated with terlipressin and albumin, yet permanent terlipressin withdrawal was required in only 3 cases. Conclusions: As compared with albumin, treatment with terlipressin and albumin is effective in improving renal function in patients with cirrhosis and hepatorenal syndrome. Further studies with large sample sizes should be performed to test whether the improvement of renal function translates into a survival benefit.

Section snippets

Study Population

A total of 67 consecutive patients with cirrhosis and HRS diagnosed between January 2002 and February 2006 in 9 university hospitals were evaluated for inclusion in the study. The study was approved by the investigational review board at each hospital, and patients or relatives gave written informed consent to participate. Inclusion criteria were as follows: (1) cirrhosis as diagnosed by liver biopsy or clinical, biochemical, ultrasound, and/or endoscopic findings; (2) HRS either type 1, as

Baseline Characteristics of the Patients

There were no significant differences between the 2 groups in clinical and laboratory data at enrollment (Table 1). Both groups were also similar with respect to the percentage of patients with type 1 HRS (74% in the terlipressin and albumin group vs 78% in the albumin group). Twelve patients in the terlipressin and albumin group and 8 patients in the albumin group had an infection as the precipitating event of HRS (spontaneous bacterial peritonitis in 5 and 2 patients, respectively).

Renal Function

Discussion

The main finding of this randomized comparative study is that the administration of terlipressin, a powerful vasoconstrictor drug acting through V1 vasopressin receptors, together with albumin is effective in improving renal function in patients with cirrhosis and HRS. In fact, renal function improved in 43.5% of patients treated with terlipressin and albumin compared with only 8.7% of control patients treated with albumin alone (P = .017). This indicates that HRS is reversible by pharmacologic

References (30)

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Supported by grants from Fundació Marató TV3 (2000.TV.2710-0) and Ministerio de Educación y Ciencia (SAF 2001/0300) and Instituto Reina Sofia de Investigación Nefrologia; a grant from the Fundación Banco de Bilbao-Vizcaya-Argentaria (FBBVA; to M.M-L.); a grant from the Fondation du Centre Hospitalier de l'Université de Montréal (CHUM; to M-N.P.); and a grant from Fondo de Investigación Sanitaria (FIS 01/3045; to M.G.). Ciberehd is funded by the Instituto de Salud Carlos III.

Financial disclosures and conflicts of interest: Pere Ginès has received research support and lecture fees from Ferring Pharmaceuticals and research support from Orphan Therapeutics. Mónica Guevara has received lecture fees from Ferring Pharmaceuticals. The remaining authors have no conflicts of interest.

M.M-L. and M-N.P. contributed equally to this work.

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