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Albumin Surpasses Polygeline in Intravascular Fluid Loading Trial: Presented at AASLD

By Jane Salodof MacNeil

BOSTON, MA -- October 30, 2003 -- Human albumin produced better outcomes than polygeline and proved more cost effective in the first randomised, double-blind trial comparing colloids for intravascular fluid loading in patients with cirrhosis and ascites.

These results were presented here October 26^th at the 54^th Annual Meeting of the American Association for the Study of Liver Diseases.

The French government stopped the trial prematurely because of fears about Mad Cow disease -- synthetic polygeline is derived from bovine bone -- but the results were clearly in favor of albumin, according to researcher Richard Moreau, MD, Hôpital Beaujon, Clichy, France.

Dr. Moreau presented data based on 68 of 81 randomised patients. Thirty patients received 20% albumin for paracentesis and/or complications requiring fluid loading, and 38 were assigned to polygeline.

More of the albumin patients stayed on the colloid long enough for the researchers to record a 6-month follow-up figure of 40% still participating versus 16% still participating in the polygeline group. The polygeline group's higher drop-out rate was not related to the discontinuance of the trial, according to Moreau.

Dr. Moreau said a key factor was that more patients on polygeline had a different colloid added to their treatment regimens and, therefore, were dropped from follow-up. "That indicated the difference in effectiveness," he said.

Liver-related events were less frequent in the albumin group; they were calculated at 4.3 per hundred days compared to 9.6 for the patients on polygeline. The number of episodes of ascites requiring paracentesis per hundred days was also lower: 3.3 compared to 7.

The clinical benefits translated in cost benefits, according to the researchers. Because patients had fewer liver-related events and required less treatment, cost per patient for the albumin group was significantly lower -- 3,135 euros versus 6,221 Euros per patient on polygeline.

"The cost of albumin is 10 times higher than 1 unit of polygeline, but the final cost is the reverse," said Moreau. "[The final cost] is much lower with albumin than with polygeline."


[Study Title: Multicenter, Randomized, Controlled, Double-Blind Trial Comparing Albumin with Polygeline for Intravascular Fluid Loading in Patients with Cirrhosis and Ascites. Abstract 543]

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