This article has been corrected. See "알라닌아미노전달효소가 상승된 만성간질환 환자에서 Biphenyl Dimethyl Dicarboxylate와 Ursodeoxycholic Acid의 유효성과 안정성을 평가하는 무작위배정, 이중맹검, 다기관 제4상 임상시험" in Volume 79 on page 52.
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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.
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 | Fig. 1.Study participation flow chart. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate. |
 | Fig. 2.Proportion of subjects with ALT normalization. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate. |
 | Fig. 3.ALT (A) and AST (B) levels during treatment. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate. |
 | Fig. 4.Changes in liver stiffness values during treatment. UDCA, ursodeoxycholic acid; DDB, biphenyl dimethyl dicarboxylate. |
 | 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. |
Table 1.
Baseline Characteristics of the Study Population
Table 2.
Overall Adverse Events by Treatment Group
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