title: Prevalence of amiodarone-related hepatotoxicity in 720 Chinese patients with or without baseline liver dysfunction.
abstract: BACKGROUND
  The prevalence of hepatotoxicity after longterm oral amiodarone therapy in Chinese patients with or without elevated liver enzymes at baseline is unknown.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, China.
authors.forename: Leo C C
authors.initials: LC
authors.lastname: Kum
authors.forename: Winnie W L
authors.initials: WW
authors.lastname: Chan
authors.forename: Helen H Y
authors.initials: HH
authors.lastname: Hui
authors.forename: Grace W M
authors.initials: GW
authors.lastname: Wong
authors.forename: Susan S S
authors.initials: SS
authors.lastname: Ho
authors.forename: John E
authors.initials: JE
authors.lastname: Sanderson
authors.forename: Cheuk-Man
authors.initials: CM
authors.lastname: Yu
authors.forename: Jeffery W H
authors.initials: JW
authors.lastname: Fung
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D000465:Algorithms; D000638:Amiodarone / Q000009:adverse effects*; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000188:drug therapy; D001282:Atrial Flutter / Q000188:drug therapy; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology* / Q000209:etiology; D002681:China; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects*; D008107:Liver Diseases; D008111:Liver Function Tests; D008297:Male; D015995:Prevalence; D012189:Retrospective Studies; D013610:Tachycardia / Q000188:drug therapy
chemical_list: D000889:Anti-Arrhythmia Agents; D000410:Alanine Transaminase; D000638:Amiodarone