PMID- 10225746 OWN - NLM STAT- MEDLINE DCOM- 19990527 LR - 20191103 IS - 1091-6660 (Print) IS - 1091-6660 (Linking) VI - 1 IP - 3 DP - 1997 Aug TI - Low-density lipoprotein apheresis for prevention and regression of atherosclerosis: clinical results. PG - 242-8 AB - Hypercholesterolemia can be adequately controlled by appropriate diet and maximum lipid lowering drug therapy in most patients. Nevertheless, there exists a group of patients, including those with familial hypercholesterolemia (FH), who remain at high risk for the development or progression of premature coronary heart disease (CHD). For these patients additional measures such as surgery and low-density lipoprotein (LDL) apheresis have to be considered. The objective of this multicenter trial, which included 30 clinical centers (28 in Germany and one each in Scotland and Luxembourg), was to determine if repeated LDL apheresis using the Liposorber LA-15 system (Kaneka Corporation, Osaka, Japan) could lead to an additional acute and time averaged lowering of total cholesterol (TC) and LDL-cholesterol (LDL-C) in severely hypercholesterolemic patients whose cholesterol levels could not be controlled by appropriate diet and maximum drug therapy. A total of 6,798 treatments were performed on 120 patients, including 8 with homozygous FH, 75 with heterozygous FH, and 37 with unclassified FH or other hyperlipidemias from 1988 through 1994. The mean TC and mean LDL-C levels at baseline were 410.0 mg/dl and 333.9 mg/dl, respectively. LDL apheresis was performed once a week or at least once every 2 weeks in all patients. During treatment with the Liposorber system the mean acute percentage reduction was 52.6% for TC and 63.1% for LDL-C. Very low density lipoprotein cholesterol (VLDL-C) and triglycerides (TG) were also substantially reduced to 60.6% and 47.5%, respectively. Fibrinogen, a potential risk factor for CHD, was reduced by 26.2%. In contrast, the mean acute reduction of high density lipoprotein (HDL) was only 3.4%. During the course of the treatment, the time averaged levels of TC and LDL-C were reduced by approximately 39% and 50%, respectively, compared to baseline levels. The adverse events (AEs) were those generally associated with extracorporeal treatments. The most common AE was hypotension, with 69 episodes corresponding to 1% of all treatments reported in 44 of the 120 patients treated. All other kinds of AEs occurred in less than 0.2% of the treatments. The treatment with the Liposorber LA-15 system was overall well tolerated. It should be noted, however, that a more severe type of hypotensive reaction associated with flush, bradycardia, and dyspnea was reported in patients taking concomitant angiotensin converting enzyme (ACE) inhibitor medication. Except for such anaphylactoid-like reactions associated with the intake of ACE inhibitors, the Liposorber LA-15 system represents a safe and effective therapeutic option for patients suffering from severe hypercholesterolemia that could not be adequately controlled by diet and maximum drug therapy. FAU - Bambauer, R AU - Bambauer R AD - German Clinical Trial Group, Homburg/Saar, Germany. FAU - Olbricht, C J AU - Olbricht CJ FAU - Schoeppe, E AU - Schoeppe E LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PL - United States TA - Ther Apher JT - Therapeutic apheresis : official journal of the International Society for Apheresis and the Japanese Society for Apheresis JID - 9706703 RN - 0 (Cholesterol, LDL) RN - 97C5T2UQ7J (Cholesterol) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Arteriosclerosis/blood/etiology/*prevention & control MH - Blood Cell Count MH - *Blood Component Removal/methods MH - Child MH - Cholesterol/blood MH - Cholesterol, LDL/*blood MH - Disease Progression MH - Female MH - Follow-Up Studies MH - Humans MH - Hyperlipoproteinemia Type II/blood/complications/therapy MH - Male MH - Middle Aged MH - Retrospective Studies MH - Safety EDAT- 1997/08/01 00:00 MHDA- 1999/05/04 00:01 CRDT- 1997/08/01 00:00 PHST- 1997/08/01 00:00 [pubmed] PHST- 1999/05/04 00:01 [medline] PHST- 1997/08/01 00:00 [entrez] AID - 10.1111/j.1744-9987.1997.tb00145.x [doi] PST - ppublish SO - Ther Apher. 1997 Aug;1(3):242-8. doi: 10.1111/j.1744-9987.1997.tb00145.x.