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