EFFECTS OF 2 DIFFERENT ADMINISTRATION REGIMENS OF GEMFIBROZIL ON PLASMA-LIPIDS, LIPOPROTEINS, AND APOPROTEINS

A double-blind, double-dummy, 16-week study on the lipid-lowering efficacy and tolerability of gemfibrozil in two dosage regimens (900 mg once daily and 600 mg BID) was carried out. Forty-eight subjects with primary hyperlipidemia were enrolled in the study. Patients with non-insulin dependent diabetes were eligible for inclusion in the study if their diabetes was well controlled. A six-week American Heart Association step-1 isocaloric diet preceded the active treatment period. During gemfibrozil treatment, lipid, apoprotein (apo) and lipoprotein changes were similar between the two treatments. Gemfibrozil 900 mg decreased total cholesterol (TC) by 19.8%, triglycerides (TG) by 44.8%, low-density lipoprotein-cholesterol (LDL-C) by 19.9%, TC/high-density lipoprotein-cholesterol (HDL-C) ratio by 30.4%, and apo B by 16.5%, and increased HDL-C by 15% and apo A-I by 9.7%. Gemfibrozil 600 mg BID decreased TC by 15.6%, TG by 41%, LDL-C by 17.6%, TC/HDL-C ratio by 31%, and apo B by 19.4%, and increased HDL-C by 18.7% and apo A-I by 13.5%. Adverse events were transitory, mild, and balanced between the two treatment groups. Results of this study show that the lipid-lowering efficacy and tolerability of gemfibrozil 900 mg given once a day and gemfibrozil 600 mg BID are similar.