A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis
Journal of Hepatology, 04/20/2011
Ratziu V et al. – Treatment with high–dose Ursodeoxycholic acid (HD–UDCA) was safe, improved aminotransferase levels, serum fibrosis markers, and selected metabolic parameters. Studies with histologic end points are warranted.Methods
- The authors conducted a 12–month, randomized, double–blind, placebo–controlled multicenter trial to evaluate the efficacy and safety of HD–UDCA (28–35 mg/kg per day) in 126 patients with biopsy–proven NASH and elevated alanine aminotransferase (ALT) levels.
- The primary study end point was reduction in ALT levels from baseline in patients treated with HD–UDCA compared with placebo.
- Secondary study end points were the proportion of patients with ALT normalization, relative reduction in the scores of serum markers of fibrosis and hepatic inflammation, and safety and tolerability.
- HD–UDCA significantly reduced mean ALT levels –28.3% from baseline after 12 months compared with –1.6% with placebo (p <0.001).
- At the end of the trial, ALT levels normalized (≤35 IU/L) in 24.5% of patients treated with HD–UDCA and in 4.8% of patients who received placebo (p = 0.003).
- Both results were not accounted for by changes in weight during the trial. HD–UDCA significantly reduced the FibroTest® serum fibrosis marker (p <0.001) compared with placebo.
- HD–UDCA also significantly improved markers of glycemic control and insulin resistance.
- There were no safety issues in this population.