Korean J Gastroenterol.  2014 Jul;64(1):31-39. 10.4166/kjg.2014.64.1.31.

Comparison on the Efficacy and Safety of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycholic Acid in Patients with Abnormal Alanine Aminotransferase: Multicenter, Double-blinded, Randomized, Active-controlled Clinical Trial

• Lee SH
• Cheon GJ
• Kim HS
• Kim YD
• Kim SG
• Kim YS
• Jeong SW
• Jang JY
• Kim BS

• KMID: 1791892
• DOI: http://doi.org/10.4166/kjg.2014.64.1.31

Abstract

BACKGROUND/AIMS
Chronic hepatocellular damage is closely associated with hepatic fibrosis and fatal complication in most liver diseases. The aim of this study is to compare the efficacy and safety of biphenyl dimethyl dicarboxylate (DDB) and ursodeoxycholic acid (UDCA) in patients with abnormal ALT.
METHODS
One-hundred thirty-five patients with elevated ALT were randomized to receive either 750 mg/day of DDB or 300 mg/day of UDCA for 24 weeks in 4 referral hospitals. Ninety-three (69%) patients had non-alcoholic steatohepatitits, 27 (20%) had alcoholic hepatitis, and 15 (11%) had chronic hepatitis. The primary end point was the rate of ALT normalization at week 24. The secondary endpoints were changes in AST, liver stiffness, and the incidence of adverse events.
RESULTS
A total of 101 patients completed 24 weeks of therapy. ALT normalization at week 24 was observed in 44 (80.0%) patients in DDB group and 16 (34.8%) in UDCA group (p<0.001). Higher mean reduction of ALT levels from baseline to 24 weeks was seen in DDB group compared with UDCA group (-70.0% vs. -35.9%, p<0.001). Normalization of AST level (p=0.53) and change in the liver stiffness (p=0.703) were not significantly different between the two groups. Severe adverse drug reaction occurred in 1 patient in DDB group but the subject continued therapy during the study period.
CONCLUSIONS
DDB was not inferior to UDCA for normalizing ALT level. Furthermore it was safe and well tolerated by patients with abnormal ALT.

Keyword

Biphenyl dimethyl dicarboxylate; Ursodeoxycholic acid; Alanine aminotransferase; Liver injury

MeSH Terms

Adolescent
Adult
Aged
Alanine Transaminase/*blood
Cholagogues and Choleretics/*therapeutic use
Dioxoles/*therapeutic use
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Hepatitis, Alcoholic/*drug therapy
Hepatitis, Chronic/*drug therapy
Humans
Male
Middle Aged
Non-alcoholic Fatty Liver Disease/*drug therapy
Tertiary Care Centers
Treatment Outcome
Ursodeoxycholic Acid/*therapeutic use
Young Adult
Alanine Transaminase
Cholagogues and Choleretics
Dioxoles
Ursodeoxycholic Acid

Figure

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  Fig. 1. Study participation flow chart. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate.

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  Fig. 2. Proportion of subjects with ALT normalization. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate.

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  Fig. 3. ALT (A) and AST (B) levels during treatment. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate.

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  Fig. 4. Changes in liver stiffness values during treatment. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate.

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  Fig. 5. Mean percentage change at the end of treatment compared with baseline for ALT, AST, and liver stiffness in the UDCA arm and DDB arm. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate.

Reference

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