EFFECT OF URSODEOXYCHOLIC ACID ON SERUM-LIPIDS OF PATIENTS WITH PRIMARY BILIARY-CIRRHOSIS

Objective: To study the effects of ursodeoxycholic acid (UDCA) on lipi d levels in patients with primary biliary cirrhosis (PBC). Design: A r andomized, placebo-controlled prospective trial of UDCA was conducted in 177 well-characterized patients,vith PBC. Material and Methods: The two treatment groups (placebo and UDCA) were matched at entry with re spect to age, sex, histologic stage of PBC, biochemical values, and se rum lipid levels. Serum cholesterol, high-density lipoprotein choleste rol, and triglyceride levels were measured at entry, 1 year, and 2 yea rs. Results: The decrease in total cholesterol level at 1 and 2 years in the UDCA-treated group was significant in comparison with that in t he placebo group. Serum high-density lipoprotein cholesterol and trigl yceride levels, however, were unchanged. No severe side effects from U DCA were noted. The changes in serum cholesterol levels at 2 years wer e directly and strongly correlated with changes in serum bilirubin con centrations (r = 0.70; P < 0.001) and inversely correlated with initia l serum cholesterol levels (r = -0.86; P < O.OOOO1). Conclusion: The c holesterol-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.