A comparison of different formulations and dosage administrations of gemfibrozil.

To assess the lipid-regulating effects of 2 new gemfibrozil formulations, a nonblind parallel group comparison was performed using Finnish industrial workers with types IIA and IIB primary hyperlipoproteinemia. In all, 670 subjects were evaluated; 416 had total low density lipoprotein (LDL) cholesterol (serum total cholesterol--high density lipoprotein [HDL] cholesterol) levels greater than or equal to 200 mg/dl and thus qualified for the screening period of the trial. During this 2-month period, the subjects were placed on an optimal diet according to their Fredrickson phenotype. Those whose total LDL levels remained greater than or equal to 200 mg/dl until the end of the 2-month period (n = 321) were admitted to the active drug phase of the trial and randomized to 1 of 3 treatment groups. Group 1 received the standard gemfibrozil dosage of two 300-mg capsules 2 times a day, for a total daily dosage equal to 1,200 mg. Group 2 also received a 1,200-mg daily dose, given as a 600-mg tablet of gemfibrozil 2 times a day. Group 3 received a once-a-day dose of two 450-mg tablets in the evening. Preliminary results show that the alternate gemfibrozil formulations are thus far equal to the standard gemfibrozil dosage in their effects on blood lipids. Substantial decreases have been noted in serum cholesterol, serum triglycerides, LDL cholesterol and serum apolipoprotein B. The 3 formulations also produced similar increases in HDL cholesterol and its subfractions HDL2 and HDL3, as well as in serum apolipoproteins AI and AII.

RCT Entities:   Population Interventions Outcomes