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Original Research

Efficacy and tolerability of diphenyl-dimethyldicarboxylate plus garlic oil in patients with chronic hepatitis

Min Ho Lee, Young Mi Kim and Sang Geon Kim

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Volume 50 p. 778 - 786

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 11/2012 (778-786)

Efficacy and tolerability of diphenyl-dimethyldicarboxylate plus garlic oil in patients with chronic hepatitis

Min Ho Lee¹, Young Mi Kim² and Sang Geon Kim²

¹Department of Internal Medicine, Hanyang University Hospital, and ²College of Pharmacy, Seoul National University, Seoul, South Korea
Objective: To investigate the hepatoprotective effect, safety and tolerability of oral preparation comprising dimethyl-4,4’-dimethoxy-5,6,5’,6’-dimethylene dioxybiphenyl-2,2’-dicarboxylate (DDB) plus garlic oil (GO) in chronic hepatitis patients. Methods: In this double-blind, placebo-controlled clinical trial conducted for 6 weeks with 1-week follow-up, a total of 88 patients with histologically confirmed chronic hepatitis and persistently elevated levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were enrolled and randomly assigned to one of 4 treatment groups: placebo (Group A) and 3 escalating dose groups (2, 3, or 6 study drug capsules a day) (Groups B – D). Each study drug capsule contains 25 mg DDB plus 50 mg GO. Efficacy was assessed by monitoring changes in the circulating activities of ALT and AST as surrogate markers for liver injury. Safety and tolerability were assessed based on the evaluation of clinically adverse events and laboratory test results. Results: Of 88 patients, 83 took at least one dose of study drug and 79 completed the study without any protocol violation. The majority of patients (81/83, 98%) had been infected with HBV. The proportions of patients whose ALT levels returned to normal ranges at Week 6, a primary outcome, were significantly different among 4 groups: 16% (3/19), 41% (9/22), 52% (11/21), and 88% (15/17) in Groups A, B, C, and D, respectively (p < 0.001). The proportions were significantly higher in Groups C (p = 0.022) and D (p < 0.001) but not in Group B compared to Group A. Interestingly, the proportion of Group D was higher than that of Group C (p = 0.034), suggesting a dose-response effect of DDB plus GO on the decrease of ALT levels. The mean ALT levels started to decrease from Week 1 in patients treated with DDB plus GO, whereas no decrease was seen in placebo group. The mean AST levels had a decreasing trend in all doses of DDB plus GO groups. Notably, patients treated with 6 capsules of DDB plus GO daily exhibited the statistically significant decrease in AST levels from Week 3. However, there was no difference in the proportions of patients with the AST decrease to normal ranges after 6-week therapy among 4 groups. The effects of DDB plus GO on decreases in ALT and AST levels lasted until 1 week after completion of treamment. Additionally, the ratios of ALT to AST gradually decreased in patients treated with DDB plus GO over time, suggesting higher degrees of reduction in ALT than in AST in those groups. No clinically meaningful adverse events and laboratory abnormalities were observed during the study period. Conclusions: The 6-week treatment of DDB plus GO lowered serum aminotransferase activities in patients with chronic hepatitis induced by HBV and/or HCV and was well tolerated. For the treatment of viral hepatitis patients, the optimal dose of this preparation was 3 to 6 capsules per day.Correspondence to:
Min Ho Lee, MD, PhD
Department of Internal Medicine
Hanyang University Hospital
222 Wangsimni-ro, Seongdong-gu,
Seoul 133-791, South Korea
Email: [email protected]

Original

Tacrolimus therapy causes hepatotoxicity in patients with a history of liver disease

Myong Suk Ko, Young Hee Choi, Sun Hoi Jung, Jenny Sue Lee, Hyang Sook Kim, Chang Ho Lee, and Sang Geon Kim

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Volume 53 p. 363 - 371

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 53 – No. 5/2015 (363-371)

Tacrolimus therapy causes hepatotoxicity in patients with a history of liver disease

Myong Suk Ko¹, Young Hee Choi², Sun Hoi Jung³,⁸, Jenny Sue Lee⁴, Hyang Sook Kim⁵,⁸, Chang Ho Lee⁶, and Sang Geon Kim⁷,⁸

¹Department of Pharmacology, College of Pharmacy, Hanyang University, Ansan Kyeonggi-do, ²College of Pharmacy and BK²¹ PLUS R-FIND Team, Dongguk University, Seoul, ³College of Pharmacy, Chungbuk National University, Cheongju Chungcheongbuk-do, ⁴Current address: Aurora Advanced Healthcare, Brookfield, WI, USA, ⁵College of Pharmacy, Dongguk University, Seoul, ⁶Department of Pharmacology, Institute of Biomedical Science, College of Medicine, Hanyang University, Seoul, ⁷College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, and ⁸Department of Pharmacy, Seoul National University, Seoul, South Korea
Objective: Tacrolimus is known to have little hepatotoxicity. Nevertheless, a few case studies have shown liver toxicities of tacrolimus, particularly in patients on multiple medications. This study is a retrospective data analysis on the potential of tacrolimus hepatotoxicity. Methods: A data analysis was conducted on the electronic medical records (EMRs) of 2,462 Korean patients taking tacrolimus or cyclosporine from 2002 through to 2008. Alanine aminotransferase (ALT) and total bilirubin level (TBL) were also monitored. The maximum ALT, time to reach ALTmax (T_ALTmax), and TBL_ALTmax were compared between the tacrolimus and cyclosporine groups. Other possible factors that may aggravate liver function were also investigated. Results: ALTmax and TBL_ALTmax were higher in the tacrolimus group compared to the cyclosporine group (i.e., 50 IU/L vs. 41 IU/L and 1 mg/dL vs. 0.9 mg/dL, respectively), and T_ALTmax was shorter (i.e., 101 days vs. 142 days) in the tacrolimus group. In addition, the frequency of ALTmax > 3× upper limit of normal (ULN) (i.e., ALTmax > 120) was significantly increased in the tacrolimus group compared to the cyclosporine group (30% vs. 21%). The severity of tacrolimusinduced liver damage was greater in patients with history of liver disease, as indicated by > two-fold greater ALTmax than that of cyclosporine (i.e., 153 IU/L vs. 65 IU/L). Moreover, the ALTmax was significantly lowered by switching from tacrolimus to cyclosporine in patients with a history of liver disease. In patients with preexisting renal disease, neither tacrolimus nor cyclosporine showed any effect on ALTmax. Conclusion: Results indicate that tacrolimus may have a higher risk of inducing liver injury in Korean patients with a history of liver disease and may require close monitoring.Correspondence to:
Sang Geon Kim, PhD
College of Pharmacy, Seoul National University
Seoul 151-742, South Korea
or
Chang Ho Lee, PhD
Department of Pharmacology
College of Medicine, Hanyang University
Seoul 133-791, South Korea
Email: [email protected] or [email protected]

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