Adjuvant Cholylsarcosine During Ursodeoxycholic Acid Treatment of Primary Biliary Cirrhosis

We postulated that coadministration ofcholylsarcosine with ursodeoxycholic acid might provideadditional benefit to primary biliary cirrhosis patientswith an incomplete response to ursodeoxycholic acid. Our aim was to test the tolerability and theeffect of adjuvant cholylsarcosine on liver tests andplasma cholesterol in primary biliary cirrhosis patientsreceiving ursodeoxycholic acid. Four primary biliary cirrhosis patients, who, despite more than ayear of ursodeoxycholic acid therapy, had one or moreliver tests persistently equal to or greater than twicethe upper limit of normal, received cholylsarcosine (12-15 mg/kg/day) in addition toursodeoxycholic acid (13-15 mg/kg/day) for six weeks inan open label study. Values of liver tests and plasmacholesterol, determined every two weeks, remainedunchanged. One patient discontinued cholylsarcosine atweek 4 because of new-onset pruritus. Analysis ofduodenal bile acids in one patient showed 52% enrichmentin cholylsarcosine and hydrophilic bile acidsconstituted 87% of total bile acids. It is concluded thatthe addition of cholylsarcosine to ursodeoxycholic aciddid not influence liver tests in four primary biliarycirrhosis patients who had not responded completely to ursodeoxycholic acid alone. Cholylsarcosinewas absorbed and became a dominant biliary bile acid;its administration was associated with increasedpruritus.