A Randomized Controlled, Double-blind Evaluation of the Short-Term(8 weeks) Efficacy and Safety of Godex in Korean Chronic Hepatitis Patients
J Korean Soc Clin Pharmacol Ther | v.9, no.1, pp.81-96, Jun, 2001
Background/Aims: To evaluate the effect and safety of Godex(hepadif+PMC, diphenyl-dimethyl-dicarboxylate) in 95 patients with chronic liver disease, a prospective randomized double blind controlled clinical trial of a short-term(8 weeks) therapy with Godex was performed in a total 95 patients with chronic hepatitis who was diagnosed by liver biopsy or recently have a abnormal serum transaminase(ALT and/or AST) concentrations during longer than 6 months. Methods : In this clinical trial, 95 patients with chronic hepatitis patients were enrolled and allocated by a table of random digits in three groups. 32 patients received 150mg/day of PMC(control group), 30 patients received low dose of Godex(low-dose group, PMC 150mg+hepadif 600mg/day) and 33 patients received high dose of Godex(high-dose group, PMC 150mg+hepadif 900mg/day) orally for 8 weeks, and they were followed until 2 weeks without drugs to evaluate rebounding phenomenon of liver enzymes. We evaluate the effect and safety by biochemical laboratory test variables such as liver enzymes and clinical observed data at each visit date such as before(0) and 4, 8 weeks after drug treatment and 2 weeks after 8 weeks treatment. Compliance and side effects were evaluated at the same time. Results : After 4 weeks-treatment of Godex, the percentage of decrease of serum ALT levels within normal range in the low-dose and high-dose groups are about 63.6 and 80.8%, respectively and were significantly(p<0.05) lower than that of control group, 29.6%. Otherwise, after 8 weeks-treatment of Godex, those of low-dose and high-dose groups are about 54.6 and 88.5%, respectively and were significantly(p<0.05) lower compared of control group, 44.4% and that of high-dose group were more significant than low-dose group. But after 2 weeks without drugs, the rebounding phenomenon of serum ALT levels were not different within three groups and adverse effects were negligible and transient during 10 weeks. Conclusions : It is suggested that Godex is more effective and safe than PMC in the short-term treatment of chronic liver disease in Korean patients, but further evaluation about efficacy and safety of Godex for adequate duration of treatment in the large population of patients are needed.