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UDCA therapy well tolerated in Chinese with primary biliary cirrhosis

Chinese patients with primary biliary cirrhosis tolerated treatment with ursodeoxycholic acid, according to new study data.

Fifty-five patients with primary biliary cirrhosis (PBC; median age, 60 years) were treated with 1,000 mg ursodeoxycholic acid (UDCA) daily for 12 days to determine its safety and efficacy among a Chinese population. A majority of the cohort were female (85.5%), and every patient was treated with UDCA for at least 8 days.

According to results, alanine aminotransferase levels decreased among the patients after 8 days of UDCA treatment (P<.05), but most of the patients with advanced PBC had normal ALT levels throughout the study. There were no significant changes observed in ALT levels (25.75 ± 13.99 vs. 20.5 ± 11.29), aspartate aminotransferase levels (47.42 ± 20.6 U/L vs. 45.83 ± 21.12 U/L) or gamma-glutamyl transferase (GGT) levels (78.73 ± 58.27 U/L vs. 97.42 ± 60.89 U/L) before and after UDCA treatment. In addition, total bilirubin and direct bilirubin did not improve drastically (P>.05 for both). Total protein, albumin and globulin levels slightly increased after UDCA treatment (P>.05 for all). No severe adverse events leading to discontinuation of UDCA treatment were observed by the researchers.

“UDCA is well tolerated in most PBC patients and is not effective in patients with advanced stage PBC for short duration,” the researchers wrote. “Large sample, randomized trials in the future are needed to confirm the efficacy of UDCA on patients with advanced stage PBC as far as serum biochemistry and overall survival concerned.”

Disclosure: Relevant financial disclosures were not provided by researchers.