Low-density lipoprotein apheresis therapy with a direct hemoperfusion column: a Japanese multicenter clinical trial.
Low-density lipoprotein (LDL) apheresis has been applied to patients with familial hypercholesterolemia (FH) with coronary artery disease (CAD). To examine the efficacy and safety of a new type of LDL adsorption column (KLD01, Kaneka, Osaka, Japan), which deals with whole blood without separating plasma, the new system was evaluated in a multicenter trial. The present study included 33 FH patients with CAD (24 males, 9 females, 57 +/- 13 years) who were treated five times with a mean interval of 2.12 +/- 0.60 weeks between treatments. We studied the removal efficacies for serum LDL cholesterol, Lipoprotein(a) (Lp(a)) and triglyceride, the times for the preparation of the system and for treatment, symptoms, and the biochemical data. The scheduled treatments were completed by 31 patients. Serum levels of LDL cholesterol, Lp(a) and triglycerides were all significantly reduced with KLD01; 61.5 +/- 6.2%, 72.4 +/- 5.9% and 69.5 +/- 9.7%, respectively. The times for both setting up the column system (26 +/- 7 min) and treatment (138 +/- 20 min) were shorter with KLD01 than conventional methods. Adverse reactions occurred in eight cases (17 episodes), but the patients fully recovered immediately after each apheresis therapy session. We conclude that the new type of LDL adsorption column, one that deals with whole blood, is a promising apheresis therapy for FH patients in view of its efficacy, reduced time for treatment, and safety.
Second Department of Internal Medicine, University of Occupational and Environmental Health, School of Medicine, Kitakyushu, Japan. h-tasaki@med.uoeh-u.ac.jp
Hiromi
H
Tasaki
Kazuhito
K
Yamashita
Yasushi
Y
Saito
Hideaki
H
Bujo
Hiroyuki
H
Daida
Hiroshi
H
Mabuchi
Yoshihiro
Y
Tominaga
Masunori
M
Matsuzaki
Kenichi
K
Fukunari
Ryoichi
R
Nakazawa
Masahiro
M
Tsuji
Yasumasa
Y
Kawade
Shigeo
S
Yamamoto
Yukio
Y
Ueda
Kimihiro
K
Takayama
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001781:Blood Component Removal / Q000009:adverse effects / Q000379:methods*; D003327:Coronary Disease / Q000150:complications; D005260:Female; D006464:Hemoperfusion / Q000295:instrumentation*; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000628:therapy*; D017270:Lipoprotein(a) / Q000097:blood; D008077:Lipoproteins, LDL / Q000097:blood*; D008297:Male; D008875:Middle Aged; D014280:Triglycerides / Q000097:blood
D017270:Lipoprotein(a); D008077:Lipoproteins, LDL; D014280:Triglycerides