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Title: ISA: Liposorber D Decreases LDL-C and Lipoprotein (a) in High Risk Patients
URL: http://www.pslgroup.com/dg/23B38A.htm
Doctor's Guide
October 1, 2003


By Eurona Earl Tilley

KYOTO, JAPAN -- October 1, 2003 -- A novel whole blood low-density lipoprotein (LDL) apheresis system, named Liposorber D, is safe and effective in decreasing LDL cholesterol and lipoprotein (a) levels.

These findings were shown in a study including 10 patients with severe hypercholesterolaemia and coronary heart disease. Dr. Carsten Otto, Medical Department II, Klinikum University of Munich, Munich, Germany, presented the research here October 1st at the 13th International Symposium on Atherosclerosis.

Dr. Otto explained that while current LDL apheresis devices eliminate LDL particles from plasma, Liposorber D is able to absorb lipoproteins directly from whole blood using a whole-blood perfusion column called DALI. In this process, positively charged atherogenic lipoproteins -- such as LDL, very low-density lipoprotein (LDL), and lipoprotein (a) -- are adsorbed after being attracted to negatively charged dextran sulfate. Via covalent bonding, apolipoprotein B (apo B)-containing lipoproteins can be selectively bound inside the column.

Dr. Otto and colleagues evaluated 10 patients at high cardiovascular risk who underwent 93 LDL apheresis procedures. Each patient had undergone previous LDL apheresis techniques.

After received Liposorber D treatment, LDL cholesterol was reduced significantly by 62.2%. If haemodilution was performed, the reduction was 58.0%. Similarly, the mean reduction in lipoprotein (a) was 55.6% and 55.3% if haemodilution was performed.

While there were no changes in high-density lipoprotein (HDL) cholesterol levels among the patients, the fibrinogen concentration was reduced by 12% per apheresis procedure.

Liposorber D appeared to be safe and well tolerated. "In comparing the first and last apheresis procedures of each patient, safety parameters did not change significantly," Dr. Otto said. However, a lower blood glucose level was recorded prior to the last procedure.

Minor complications seen during the study included 3 episodes of hypocalcaemia, and 2 episodes of arterial hypotension. The Liposorber D technique did not need to be suspended in either situation.

Dr. Otto said the mean treatment time of a single apheresis procedure is 112 minutes.

He concluded that Liposorber D is safe and beneficial in treating homozygous familial hypercholesterolaemia, and severe treatment-resistant hypercholesterolaemia.


[Study title: Efficacy and Safety of a New Whole-Blood Low-Density Lipoprotein Apheresis System (Liposorber D) in Severe Hypercholesterolemia. Abstract 2P-0591]

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