LONG-TERM EFFECTS OF LOW-DENSITY-LIPOPROTEIN APHERESIS USING AN AUTOMATED DEXTRAN SULFATE CELLULOSE ADSORPTION SYSTEM

The short-term effectiveness of low-density lipoprotein (LDL) apheresi s using a dextran sulfate cellulose adsorption column technique was pr eviously examined in a 9-center, 22-week controlled trial in 64 patien ts with familial hypercholesterolemia (FH) who did not adequately resp ond to diet and drug therapy. Forty-nine patients (40 treatment, 9 con trols) subsequently received LDL apheresis procedures as part of an op tional follow-up phase. This study reports on the long-term safety, li pid lowering, and clinical efficacy of LDL apheresis for the 5-year pe riod that includes both the initial controlled study and follow-up pha se. During this time, patients received a total of 3,902 treatments bf which 3,314 treatments were given during the follow-vp phase. Adverse events were infrequent, occurring in 142 procedures (3.6%). Immediate reduction in LDL cholesterol was 76% both in homozygotes and in heter ozygotes. Patients with homozygous FH had a progressive decrease in pr etreatment LDL cholesterol level along with an increase in high-densit y lipoprotein (HDL) cholesterol level. There wets no appreciable chang e in pretreatment lipoprotein level over time in heterozygotes. The ra te of cardiovascular events during therapy with LDL apheresis and lipi d-lowering drugs was 3.5 events per 1,000 patient-months of treatment compared with 6.3 events per 1,000 patient-months for the 5 years befo re LDL apheresis therapy. These findings support the long-term safety and clinical efficacy of LDL apheresis in patients with heterozygous a nd homozygous FH who are inadequately controlled with drug therapy. (C ) 1998 by Excerpta Medica, Inc.