Premium
Low‐density Lipoprotein Apheresis Therapy With a Direct Hemoperfusion Column: A Japanese Multicenter Clinical Trial
Author(s) -
Tasaki Hiromi,
Yamashita Kazuhito,
Saito Yasushi,
Bujo Hideaki,
Daida Hiroyuki,
Mabuchi Hiroshi,
Tominaga Yoshihiro,
Matsuzaki Masunori,
Fukunari Kenichi,
Nakazawa Ryoichi,
Tsuji Masahiro,
Kawade Yasumasa,
Yamamoto Shigeo,
Ueda Yukio,
Takayama Kimihiro
Publication year - 2006
Publication title -
therapeutic apheresis and dialysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.415
H-Index - 53
eISSN - 1744-9987
pISSN - 1744-9979
DOI - 10.1111/j.1744-9987.2006.00315.x
Subject(s) - hemoperfusion , medicine , apheresis , familial hypercholesterolemia , coronary artery disease , ldl apheresis , lipoprotein , clinical trial , adverse effect , triglyceride , gastroenterology , multicenter trial , cholesterol , multicenter study , randomized controlled trial , platelet , hemodialysis
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.