Effect of ursodeoxycholic acid on serum lipids of patients with primary biliary cirrhosis.

OBJECTIVE

To study the effects of ursodeoxycholic acid (UDCA) on lipid levels in patients with primary biliary cirrhosis (PBC).

DESIGN

A randomized, placebo-controlled prospective trial of UDCA was conducted in 177 well-characterized patients with PBC.

MATERIAL AND

METHODS

The two treatment groups (placebo and UDCA) were matched at entry with respect to age, sex, histologic stage of PBC, biochemical values, and serum lipid levels. Serum cholesterol, high-density lipoprotein cholesterol, and triglyceride levels were measured at entry, 1 year, and 2 years.

RESULTS

The decrease in total cholesterol level at 1 and 2 years in the UDCA-treated group was significant in comparison with that in the placebo group. Serum high-density lipoprotein cholesterol and triglyceride levels, however, were unchanged. No severe side effects from UDCA were noted. The changes in serum cholesterol levels at 2 years were directly and strongly correlated with changes in serum bilirubin concentrations (r = 0.70; P < 0.001) and inversely correlated with initial serum cholesterol levels (r = -0.86; P < 0.00001).

CONCLUSION

The cholesterol-lowering effect of UDCA could be related to amelioration of the underlying liver disease or to a direct effect of the drug on the metabolism of cholesterol in patients with hypercholesterolemia.