ADJUVANT CHOLYLSARCOSINE DURING URSODEOXYCHOLIC ACID TREATMENT OF PRIMARY BILIARY-CIRRHOSIS

We postulated that coadministration of cholylsarcosine with ursodeoxyc holic acid might provide additional benefit to primary biliary cirrhos is patients with an incomplete response to ursodeoxycholic acid. Our a im was to test the tolerability and the effect of adjuvant cholylsarco sine on liver tests and plasma cholesterol in primary biliary cirrhosi s patients receiving ursodeoxycholic acid. Four primary biliary cirrho sis patients, who, despite more than a year of ursodeoxycholic acid th erapy, had one or more liver tests persistently equal to or greater th an twice the upper limit of normal, received cholylsarcosine (12-15 mg /kg/day) in addition to ursodeoxycholic acid (13-15 mg/kg/day) for six weeks in an open label study. Values of liver tests and plasma choles terol, determined every two weeks, remained unchanged. One patient dis continued cholylsarcosine at week 4 because of new-onset pruritus. Ana lysis of duodenal bile acids in one patient showed 52% enrichment in c holylsarcosine and hydrophilic bile acids constituted 87% of total bil e acids. It is concluded that the addition of cholylsarcosine to ursod eoxycholic acid did not influence liver tests in four primary biliary cirrhosis patients who had not responded completely to ursodeoxycholic acid alone. Cholylsarcosine was absorbed and became a dominant biliar y bile acid; its administration was associated with increased pruritus .