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

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 co nducted 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 rando mly 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 maj or clinical symptoms of fatigue and dyspepsia; however, pruritus was signif icantly 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 aminotransfera se, alanine aminotransferase, gamma-glutamyltransferase (GGT), alkaline pho sphatase, total cholesterol, triglycerides, fractioned bilirubin, prothromb in time, and serum albumin. Liver ultrasonography was performed at baseline and at the end of treatment. Each clinical symptom was assessed on a 4-poi nt scale, in which 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Duri ng the study period, 7 patients (3 in the TUDCA-treated group and 4 in the placebo group) were withdrawn; 33 patients completed the study.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 de creased 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 grou p, transaminases had decreased significantly (P < 0.05) after 3 months; thi s decrease was maintained at 6 months. In the TUDCA group, a significant re duction in transaminase values was reached at 6 months (P < 0.01). The othe r biochemical variables did not show any significant change in either group . Results of this study suggest that TUDCA is ineffective in inducing a bio chemical remission in HCV-related cirrhosis in the elderly.