Prevalence of amiodarone-related hepatotoxicity in 720 Chinese patients with or without baseline liver dysfunction

Abstract

Background: The prevalence of hepatotoxicity after long-term oral amiodarone therapy in Chinese patients with or without elevated liver enzymes at baseline is unknown. Hypothesis: Amiodarone may still be safely prescribed for Chinese patients who have baseline liver dysfunction. Methods: This is a retrospective cross-sectional study. Significant liver dysfunction (SLD) was defined as alanine aminotransferase (ALT) > 2 times upper limit of normal range. Results: Baseline liver function was checked in 628 of the 720 Chinese patients identified. The mean duration of amiodarone use was 615.9 ± 703.1 days. Ninety patients (14.3%) had elevated baseline ALT. The prevalence of SLD was 3.7% (confidence interval [CI] 2.1-5.3%) and 4.4% (CI 0.2-8.6%) in patients with normal (n = 538) and elevated (n = 90) baseline ALT, respectively (p = 0.765). Therapy was continued in 42 patients with elevated baseline ALT until final follow-up. Eight of these (19.0%) had elevated ALT upon final follow-up, but the derangement was mud (mean ALT 134.8 ± 145.9 IU/l, median 76IU/l). During follow up, 24 patients developed SLD and half of these subsequently withdrew from therapy. The ALT levels at final follow-up had improved over time in both groups, but the mean difference was not significant (255.1 ± 706.4 vs. 131.0 ± 207.5 IU/l, p = 0.312). Conclusion: The prevalence of SLD in Chinese patients taking oral amiodarone with or without elevated baseline ALT was similar (4.4 vs. 3.7%). It seems that amiodarone may be safely prescribed in patients with elevated baseline ALT.