EFFECT OF TAUROURSODEOXYCHOLIC ACID ON SERUM LIVER-ENZYME AND SERUM-LIPID LEVELS IN PATIENTS WITH CHRONIC ACTIVE HEPATITIS

Tauroursodeoxycholic acid (TUDCA) is a new natural bile acid amidate b eing 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 li ver enzymes, total bilirubin, and serum lipid levels in patients with biopsy-proven chronic active hepatitis due to hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. The study population included 13 4 anti-HCV-positive and 28 hepatitis B surface antigenpositive patient s. TUDCA was well tolerated and safe and was associated with a signifi cant (P < 0.001) decrease in all serum liver enzyme levels. Aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltransfer ase 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 addit ional 5% to 10% by the end of 3 months of therapy. A slight improvemen t in total bilirubin levels was also observed. In addition, TUDCA caus ed a slight, but significant, improvement in serum lipid profiles (dec reased 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-t erm, prospective, placebocontrolled, double-blind studies.