Effect of tauroursodeoxycholic acid on serum liver enzyme and serum lipid levels in patients with chronic active hepatitis

Abstract

Tauroursodeoxycholic acid (TUDCA) is a new natural bile acid amidate being investigated as a gallstone-dissolving agent in humans. We report herein the results of a multicenter, cooperative study that involved 12 hospitals throughout Italy, aimed at evaluating the effects of long-term oral administration of TUDCA (500 mg/d for 3 months) on serum liver enzymes, total bilirubin, and serum lipid levels in patients with biopsy-proven chronic hepatitis due to hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. The study population included 134 anti-HCV—positive and 28 hepatitis B surface antigen-positive patients. TUDCA was well tolerated and safe and was associated with a significant ( P < 0.001) decrease in all serum liver enzyme levels. Aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltransferase levels decreased by a mean of 29.7 ± 14.5%, 24.1 ± 15.9%, and 26.6 ± 19.9%, respectively, after 1 month of therapy and by an additional 5% to 10% by the end of 3 months of therapy. A slight improvement in total bilirubin levels was also observed. In addition, TUDCA caused a slight, but significant, improvement in serum lipid profiles (decreased total cholesterol [ P < 0.001] and triglycerides [ P < 0.05] and increased high-density lipoprotein cholesterol [NS]). These favorable changes were similar in HCV and HBV hepatitis and were independent of age, sex, body weight, and alcohol consumption. These results indicate that TUDCA may have a place in the treatment of patients with chronic hepatitis, a possibility that needs to be verified by means of long-term, prospective, placebo-controlled, double-blind studies