Double-blind, controlled study of tauroursodeoxycholic acid in elderly patients with hepatitis C virus-related cirrhosis

Abstract

To date no effective drug has been available for the treatment of hepatitis C virus (HCV)-related cirrhosis in elderly patients. A randomized, double-blind, placebo-controlled study of tauroursodeoxycholic acid (TUDCA) was conducted in elderly patients with HCV-related cirrhosis. Forty patients (14 men and 26 women; mean age, 70 years; age range, 65 to 79 years) were randomly allocated to receive either TUDCA 500 mg/d or placebo for 6 months. At baseline, the 2 groups were comparable in terms of the frequency of the major clinical symptoms of fatigue and dyspepsia; however, pruritus was significantly more severe in the TUDCA treatment group ( P < 0.05). The following assessments were made at baseline and after 3 and 6 months of treatment: a complete clinical examination and determination of aspartate aminotransferase, alanine amino-transferase, gamma-glutamyltransferase (GGT), alkaline phosphatase, total cholesterol, triglycerides, fractioned bilirubin, prothrom-bin time, and serum albumin. Liver ultrasonography was performed at baseline and at the end of treatment. Each clinical symptom was assessed on a 4-point scale, in which 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. During the study period, 7 patients (3 in the TUDCA-treated group and 4 in the placebo group) were withdrawn; 33 patients completed the study. Pruritus decreased significantly in the TUDCA group (0.353) compared with an increase in the placebo group (0.067) ( P < 0.05). Dyspepsia and fatigue did not show any statistically significant changes in either group. In the placebo group, transaminases had decreased significantly ( P < 0.05) after 3 months; this decrease was maintained at 6 months. In the TUDCA group, a significant reduction in transaminase values was reached at 6 months ( P < 0.01). The other biochemical variables did not show any significant change in either group. Results of this study suggest that TUDCA is ineffective in inducing a biochemical remission in HCV-related cirrhosis in the elderly.