1.
Comparative study of hospital costs associated with human albumin 20% (Vialebex 20%) or polygeline as a fluid resuscitation strategy for cirrhotic ascites
Durand-Zaleski I, Alberti C, Guemas E, Golly D, Padrazzi B, Waegemans T
Presse MéDicale (Paris, France : 1983). 2007;36((6 Pt 1):):867-73.
Abstract
OBJECTIVES To compare the hospital costs associated with two fluid resuscitation strategies for cirrhotic ascites: one with human albumin 20% (Vialebex 20%) and one with polygeline. METHODS Multicenter 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. RESULTS The 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. CONCLUSION The 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.
2.
Comparison of outcome in patients with cirrhosis and ascites following treatment with albumin or a synthetic colloid: a randomised controlled pilot trail
Moreau R, Valla DC, Durand-Zaleski I, Bronowicki JP, Durand F, Chaput JC, Dadamessi I, Silvain C, Bonny C, Oberti F, et al
Liver International : Official Journal of the International Association for the Study of the Liver. 2006;26((1):):46-54.
Abstract
BACKGROUND The question of which colloid (albumin or synthetic colloids) used for plasma expansion following paracentesis or other complications requiring fluid loading in patients with cirrhosis remains controversial. AIMS To compare outcome and hospital-related cost in patients with cirrhosis treated with 20% human albumin with those treated with a synthetic colloid (3. 5% polygeline). METHODS The primary end point was occurrence of a first liver-related complication. RESULTS When the trial was prematurely discontinued because of safety concerns about bovine-derived products, 30 patients were assigned to receive albumin and 38 were assigned to receive a synthetic colloid. Sixty-three patients were included for ascites removal by paracentesis and five patients for ascites removal by paracentesis and renal impairment. The median time to first liver-related complication was not significantly longer in the albumin group (20 vs. 7 days). However, the total number of liver-related complications adjusted to a 100-day period was significantly lower in the albumin group. The median hospital cost for a 30-day period was significantly lower in the albumin group (1915 euros vs. 4612 euros). CONCLUSIONS In patients with cirrhosis and ascites, human albumin appears to be more effective in preventing liver-related complications than synthetic colloid. This may be associated with decreased hospital costs.