Effect of Ursodeoxycholic Acid Administration in Patients with Primary Hypercholesterolaemia.

Objective: A high plasma cholesterol level is a major predisposing factor for coronary artery disease, and new treatments are currently under consideration. Supported by the close relationship between cholesterol and bile acid metabolism, recent studies have reported a hypocholesterolaemic effect of the bile acid ursodeoxycholic acid (UDCA) in patients with primary biliary cirrhosis but, unfortunately, no data are available in primary hypercholesterolaemia. We performed this study to evaluate the effects of oral administration of UDCA on serum lipoprotein patterns in patients with primary hypercholesterolaemia. Design and Setting: A double-blind, placebo-controlled, crossover study with a 4-week washout period carried out at an outpatient clinic at a university hospital. Study Participants: Twelve individuals with a total serum cholesterol level >5.17 mmol/L. Intervention: Patients were assigned to receive UDCA (8 to 10 mg/kg/day) or placebo for 28 days. They then crossed over to receive the other treatment after a 4-week washout period. Main Outcome Measures and Results: Serum total, low density lipoprotein (LDL), high density lipoprotein (HDL), very low density lipoprotein (VLDL) cholesterol and apoprotein A and B were determined before and after 28-day UDCA and placebo administration. After UDCA administration, the mean (±SD) total serum cholesterol level decreased significantly from 6.37 ± 1.01 mmol/L to 6.06 ± 0.97 mmmol/L (F = 5.7, p = 0.041); no significant differences from baseline were observed in LDL, HDL, VLDL cholesterol, apoprotein A and B. No significant changes in serum lipid parameters occurred after the placebo period. When compared with placebo, the UDCA-induced decrease in total serum cholesterol levels was statistically significant (F = 5.5, p = 0.043). Conclusion: This study shows that UDCA reduces total serum cholesterol levels in patients with mild to moderate hypercholesterolaemia. This effect suggests that the administration of UDCA may improve cholesterol metabolism in these individuals. [ABSTRACT FROM AUTHOR]