Clinical experience and future directions for low-density lipoprotein apheresis in the United States

The United States Liposorber Study was a 22 week randomized controlled study of low-density lipoprotein (LDL) apheresis with an optional follow-up phase. The procedure was found to acutely lower LDL cholesterol by up to 81%, have good tolerability, and produce a reduction in the frequency of cardiovascular events. Studies outside the United States have found therapy with LDL apheresis to be associated with a favorable clinical outcome including improved myocardial perfusion, but variable regression of coronary artery disease (CAD). Improvement in blood viscosity and endothelial function may help explain the symptomatic benefits observed with relatively small changes in angiography. Based upon favorable clinical experience, LDL apheresis using dextran sulfate cellulose columns has recently received approval for commercialization in the United States in patients with inadequate responses to diet and drug therapy and LDL levels > or = 200 mg with CAD present or LDL levels > or = 300 mg/dl without CAD.