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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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