Effect of ursodeoxycholic acid administration in patients with primary hypercholesterolaemia

Objective: A high plasma cholesterol level is a major predisposing factor f or coronary artery disease, and new treatments are currently under consider ation. Supported by the close relationship between cholesterol and bile aci d 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 hypercholes terolaemia. We performed this study to evaluate the effects of oral adminis tration of UDCA on serum lipoprotein patterns in patients with primary hype rcholesterolaemia. Design and Setting: A double-blind, placebo-controlled, crossover study wit h a 4-week washout period carried out at an outpatient clinic at a universi ty 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 (LD L), high density lipoprotein (HDL), very low density lipoprotein (VLDL) cho lesterol and apoprotein A(1) and B-100 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 diff erences from baseline were observed in LDL, HPL, VLDL cholesterol, apoprote in A(1) and B-100. No significant changes in serum lipid parameters occurre d after the placebo period. When compared with placebo, the UDCA-induced de crease in total serum cholesterol levels was statistically significant (F = 5.5, p = 0.043). Conclusion: This study shows that UDCA reduces total serum cholesterol leve ls in patients with mild to moderate hypercholesterolaemia. This effect sug gests that the administration of UDCA may improve cholesterol metabolism in these individuals.