The hypolipidemic effects of
acifran were evaluated in a randomized, double-blind, placebo-controlled study of 30 patients with
type IIa hyperlipoproteinemia. Plasma
lipid and
lipoprotein values were determined at baseline (mean of three values), again after a 2-week single-blind period of
acifran dosing, and at 2-week intervals during a 10-week period of double-blind
drug dosing. At week 8, subjects who received the lower dose of
acifran (100 mg t.i.d.) showed significantly lower levels of total and
low-density lipoprotein cholesterol and
triglycerides compared with their baseline levels (P less than 0.01) or the placebo group (P less than 0.05). At week 12, subjects who received the higher dose of
acifran (300 mg t.i.d.) had an increase in
high-density lipoprotein levels of 16% (P less than 0.01) and a decrease in the ratio of low- to
high-density lipoproteins of 22% compared with their baseline levels (P less than 0.01). There were no significant differences in
lipid responses between the two groups receiving
acifran. Transient mild
flushing and
pruritus were experienced by some subjects, but no subject failed to complete the study because of
drug intolerance or side effects. The safety and efficacy demonstrated in this short-term therapeutic trial justify additional long-term studies with
acifran.