Authors and Disclosures

Moon-Seung PARK1, Ju-Seop KANG1, Chae-Yoon CHON2, Seung-Woon PAIK3, Kyu-SUng RIM4, Min-Jung KWAK5, Yong-Cheol JEON6, Min-Ho LEE6

Kor J Clin Pharmaco Ther 2006; 14(1):58-64

Division of Clinical Pharmacology Institute of Biomedical Science1 and Department of Internal Medicine6. College of Medicine, Hanyang University Department of Internal Medicine, College of Medicine, Yonsei University2 Department of Internal Medicine, College of Medicine, Sungkyunkwan University3Department of Internal Medicine, College of Medicine Pochon CHA University4 Department of Computer Science and Statistics, Pyontaek University

ABSTRACT

BACKGROUND / AIM

GODEX is a multicomponent drug that contains Carnitine Orotate, 17 amino acids, Adenine hydrochloride, and Vitamins B2, B6, B12, which has been used for managing chronic liver diseases in Korea and other countries. The purpose of this study was to evaluate the efficacy and safety of GODEX in Korean patients with chronic liver disease.

METHODS

In this study, 154 patients with chronic hepatitis, who showed a raised level of serum alanine aminotransferase (ALT), were randomly allocated into three groups. 52 patients were administered 100 mg/day of biphenyl-dimethyl-dicarboxylate (PMC), 48 patients were administered low dose of GODEX plain ( 450 mg/day) and 53 patients were administered high dose of GODEX DS (900 mg/day) orally for 8 weeks. To evaluate the efficacy and safety of GODEX capsule, we considered the proportion of patients showing a normal blood ALT level after 8-week treatment as primary variable, and the proportion of patient showing a normal ALT level 4th week, the degree of difference in serum ALT level between 0th and 8th week, and incidence of adverse events during the treatment, as second variables.

RESULTS

The percentage of subjects whose serum ALT levels decreased below the normal upper limit in control group (PMC), low-dose group (GODEX plain) and high-dose group (GODEX DS) were 64.54%, 67.35% and 81.13% respectively, (p=0.0407) after 8-week treatment, and 59.62%, 63.27% and 81.13% after 4-week treatment with control group (PMC), low-dose group (GODEX plain) and high-dose group (GODEX DS) respectively, (p=0.0790) in using ITT analysis. There was no significant difference in the incidence of adverse events among the three groups.

CONCLUSIONS

The response rate of high-dose group (GODEX DS) was significantly higher than those of low-dose group (GODEX plain) and control group (PMC). It is suggested that GODEX DS 3 capsules per day (900 mg/day) is an optimal dose for Korean patients with chronic liver disease who show a raised serum alanine aminotransferase (ALT) level.