Long-term effects of low-density lipoprotein apheresis using an automated dextran sulfate cellulose adsorption system. Liposorber Study Group.
The short-term effectiveness of low-density lipoprotein (LDL) apheresis using a dextran sulfate cellulose adsorption column technique was previously examined in a 9-center, 22-week controlled trial in 64 patients with familial hypercholesterolemia (FH) who did not adequately respond to diet and drug therapy. Forty-nine patients (40 treatment, 9 controls) subsequently received LDL apheresis procedures as part of an optional follow-up phase. This study reports on the long-term safety, lipid lowering, and clinical efficacy of LDL apheresis for the 5-year period that includes both the initial controlled study and follow-up phase. During this time, patients received a total of 3,902 treatments of which 3,314 treatments were given during the follow-up phase. Adverse events were infrequent, occurring in 142 procedures (3.6%). Immediate reduction in LDL cholesterol was 76% both in homozygotes and in heterozygotes. Patients with homozygous FH had a progressive decrease in pretreatment LDL cholesterol level along with an increase in high-density lipoprotein (HDL) cholesterol level. There was no appreciable change in pretreatment lipoprotein level over time in heterozygotes. The rate of cardiovascular events during therapy with LDL apheresis and lipid-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 before LDL apheresis therapy. These findings support the long-term safety and clinical efficacy of LDL apheresis in patients with heterozygous and homozygous FH who are inadequately controlled with drug therapy.
Gordon
B R
BR
Rogosin Institute, New York Hospital-Cornell Medical Center, New York 10021, USA.
Kelsey
S F
SF
Dau
P C
PC
Gotto
A M
AM
Graham
K
K
Illingworth
D R
DR
Isaacsohn
J
J
Jones
P H
PH
Leitman
S F
SF
Saal
S D
SD
Stein
E A
EA
Stern
T N
TN
Troendle
A
A
Zwiener
R J
RJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D001781:Blood Component Removal; D002648:Child; D002675:Child, Preschool; D002784:Cholesterol / Q000097:blood*; D016264:Dextran Sulfate; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000628:therapy*; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D008077:Lipoproteins, LDL; D014280:Triglycerides; D016264:Dextran Sulfate; D002784:Cholesterol