Abstract
. We compared the efficacy of three formulations and two dosage regimens of gemfibrozil in 322 dyslipidemic (non-high-density lipoprotein [HDL] cholesterol level, ≥5.2 mmol/L [≥200 mg/dL]) middle-aged male and postmenopausal female patients in a 1-year open-label trial. Of the patients studied, 109 received the standard 1200-mg dose of gemfibrozil, ie, two 300-mg capsules twice daily; 107 received one 600-mg tablet twice daily; and 106 received a single dose of 900 mg of gemfibrozil in two 450-mg tablets in the evening. The three treatment groups showed equal changes in each lipoprotein measure studied, ie, in serum levels of triglycerides, total cholesterol, low-density lipoprotein and HDL cholesterol, HDL subfractions HDL2 and HDL3, and apolipoproteins A-I, A-II, and B. When the therapeutic responses were analyzed separately in men (n =219) and women (n =103), significantly greater decreases in serum levels of total triglycerides, low-density lipoprotein cholesterol, and apolipoprotein B, and a significantly greater increase in HDL3 cholesterol level and apolipoprotein A-I/B ratio, were seen in the women. When the study population was divided into smokers (n = 80) and nonsmokers (n =242), the changes were similar in all lipoprotein measures except HDL3 cholesterol level, in which a significantly greater increase was seen in the nonsmokers. This study showed that gemfibrozil is as effective, or more so, in dyslipidemic postmenopausal women as in dyslipidemic middle-aged men, and that smoking does not abolish its lipid-regulating effects. Importantly, a daily dose of 900 mg was found to be as effective as the standard dose of 1200 mg.(Arch Intern Med. 1992;152:90-96)