SAFETY AND EFFICACY OF LIFIBROL UPON 4-WEEK ADMINISTRATION TO PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

The efficacy and safety of lifibrol, a novel cholesterol-lowering drug , was investigated in a double-blind clinical study in 168 patients wi th primary hypercholesterolaemia. Placebo and four lifibrol dose group s (150, 300, 450 and 600 mg/day) were tested over a period of 4 weeks. The mean LDL-cholesterol changes were 5.7%, -11.1%, -27.7%, -34.5% an d -35.0%, respectively, after 4 weeks of treatment. No major changes i n HDL-cholesterol were seen after this period. With the pre sent study design, a decrease in triglycerides (-28%) was significant in the hig hest dosage group only. Additionally, it was shown that further indepe ndent risk factors for coronary heart disease were favourably influenc ed. Fibrinogen decreased in all dosage groups with a maximal mean valu e of 18% and a tendency toward reduction in lipoprotein(a) was observe d in patients with high baseline levels (> 30 mg dl(-1)). Lifibrol was generally well tolerated in all dosage groups and no serious adverse events were reported. Laboratory parameters did not show any clinicall y relevant alterations.