Key result
Long-term oral amiodarone therapy resulted in similar rates of significant liver dysfunction in patients with elevated versus normal baseline ALT (4.4% vs 3.7%; p=0.765).
Why the study?
Does long-term oral amiodarone therapy cause significant liver dysfunction in Chinese patients with elevated baseline ALT compared to those with normal baseline ALT?
Cross-Sectional (n=720)
Does long-term oral amiodarone therapy cause significant liver dysfunction in Chinese patients with elevated baseline ALT compared to those with normal baseline ALT?
Long-term oral amiodarone therapy appears to have a similarly low prevalence of significant hepatotoxicity in Chinese patients regardless of baseline elevated ALT, suggesting it may be safely prescribed in this population.
Amiodarone hepatotoxicity rates appear similar regardless of baseline ALT in Chinese patients; hypothesis-generating and should not yet change practice.
BACKGROUND: The prevalence of hepatotoxicity after longterm 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 mild (mean ALT 134.8 +/- 145.9 IU/l, median 76 IU/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.
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Kum et al. (2006) conducted a cross-sectional in Amiodarone-related hepatotoxicity (n=720). Elevated baseline ALT vs. Normal baseline ALT was evaluated on Significant liver dysfunction (ALT > 2 times upper limit of normal range) (p=0.765). Long-term oral amiodarone therapy resulted in similar rates of significant liver dysfunction in patients with elevated versus normal baseline ALT (4.4% vs 3.7%; p=0.765).
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