[A randomized, double-blind, placebo-controlled study of the antilipemic efficacy and tolerability of food supplement policosanol in patients with moderate hypercholesterolemia].
This randomized, double-blind, placebo-controlled crossover study was performed in 67 patients of both sexes aged 20 to 78 years with moderate hypercholesterolemia to investigate the antilipemic efficacy and tolerability of food supplement policosanol--a mixture of aliphatic primary alcohols from rice (Oryza sp.). After a 8-week run-in period in which patients were placed on therapeutic lifestyle changes, in particular cholesterol-lowering diet, they were randomly assigned to receive policosanol 10 mg capsules or placebo capsules once daily with the evening meal for 8 weeks. During next 8 weeks those receiving policosanol during the first 8 weeks, received placebo and those taking placebo during the first 8 weeks, received policosanol. Total cholesterol (C), LDL-C, HDL-C, HDL2-C, HDL3-C, triglycerides, oxidized LDL, apoproteins A I and B and lipoprotein (a) as well as AST, ALT, GGT, CK, blood glucose and bilirubin were determined before the treatment, after the first part of the study i.e. after the first 8 weeks and at the end of the study, i.e after the second 8 weeks. Policosanol significantly reduced plasma total cholesterol and increased apoprotein A I but did not change plasma triglycerides, HDL-C, HDL2-C, HDL3-C, LDL-C, oxidized LDL, Lp (a) and apoproteinS. It was well tolerated, with no drug-related effects on safety parameters such as serum aminotransferases, blood glucose, bilirubin, and CK, neither did it cause any clinical adverse reactions.
Klinika za unutrasnje bolesti Klinickog boirkog centra Zagreb Medicinskog fakulteta Sveufiligta u Zagrebu.
Eugenia
E
Tedeschi-Reiner
Zeljko
Z
Reiner
Zeljko
Z
Romić
Davor
D
Ivanković
D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005233:Fatty Alcohols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D000924:Anticholesteremic Agents; D005233:Fatty Alcohols; C080710:policosanol