• Presse Med · Jun 2007

    Randomized Controlled Trial Multicenter Study

    [Comparative study of hospital costs associated with human albumin 20% (Vialebex 20%) or polygeline as a fluid resuscitation strategy for cirrhotic ascites].

    • Isabelle Durand-Zaleski, Corinne Alberti, Eric Guemas, Dominique Golly, Bruno Padrazzi, and Tony Waegemans.
    • Santé publique, Hôpital Henri Mondor, Créteil (94). isabelle.durand-zaleski@hmn.aphp.fr
    • Presse Med. 2007 Jun 1;36(6 Pt 1):867-73.

    ObjectivesTo compare the hospital costs associated with two fluid resuscitation strategies for cirrhotic ascites: one with human albumin 20% (Vialebex 20%) and one with polygeline.MethodsMulticenter prospective randomized double-blinded comparative trial (that also compared efficacy and tolerance). The economic evaluation was based on direct medical costs throughout the follow-up period: days of hospitalization, hospital consultations, medical procedures, and fluid resuscitation products. This cost-minimization study had a 6-month follow-up period. Daily costs in euros were adjusted over a 30-day period. The study was interrupted prematurely because of an alert due to the bovine origin of the polygeline, and the inclusion objectives could therefore not be met.ResultsThe economic analysis included all patients in the efficacy population (group receiving human albumin 20%: n=30, polygeline group: n=38). It found a standardized cost per patient for 30 days of treatment that was significantly lower (p=0.004) for human albumin 20% (median: 1915 euro; range: 1330-4105) than for polygeline (median: 4612 euro; range: 2138-12234). This difference is related mainly to a reduction in the frequency and duration of hospitalization in specialized units, but also to other aspects of management: hospitalization in other departments, specific solutions for the study products, and hospital procedures.ConclusionThe economic results of this trial favor a fluid resuscitation strategy that uses human albumin 20% for cirrhotic patients. They are consistent with the clinical results and help assess the cost-benefit ratio of human albumin 20% for this indication.

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