title: The incidence and predictors of overall adverse effects caused by low dose amiodarone in real-world clinical practice.
abstract: OBJECTIVE
  Most current knowledge regarding amiodarone toxicity derives from clinical trials. This study was performed to investigate the incidence and risk factors of overall adverse effects of amiodarone in real-world practice using a large sample size.
  
  
  METHODS
  Between January 1, 2000 and March 10, 2012, a total of 930 consecutive patients who had been treated with amiodarone for arrhythmia were reviewed retrospectively. An amiodarone-associated adverse event was considered in cases of discontinuation or drug dose reduction due to an unexpected clinical response.
  
  
  RESULTS
  The mean daily dose of amiodarone was 227 ± 126 mg, and the mean duration was 490 ± 812 days. During the mean follow-up duration of 982 ± 1,137 days, a total of 154 patients (16.6%) experienced adverse effects related to amiodarone, the most common being bradycardia or conduction disturbance (9.5%). Major organ toxicities in the thyroid (2.5%), liver (2.2%), eyes (0.6%), and lungs (0.3%) were rare. All patients recovered fully without complications after amiodarone discontinuation or dose reduction. The only independent predictor of adverse effects was the duration of amiodarone treatment (odds ratio, 1.21; 95% confidence interval, 1.03 to 1.41; p = 0.016, per year).
  
  
  CONCLUSIONS
  Low-dose amiodarone is well tolerated in a real-world clinical population. Further studies with a prospective design are needed to confirm this finding.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Hack-Lyoung
authors.initials: HL
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jae-Bin
authors.initials: JB
authors.lastname: Seo
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Woo-Young
authors.initials: WY
authors.lastname: Chung
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Myung-A
authors.initials: MA
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Joo-Hee
authors.initials: JH
authors.lastname: Zo
mesh_terms: D000368:Aged; D000638:Amiodarone / Q000008:administration & dosage / Q000009:adverse effects*; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001145:Arrhythmias, Cardiac / Q000188:drug therapy; D054537:Atrioventricular Block / Q000139:chemically induced / Q000453:epidemiology; D001919:Bradycardia / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D000889:Anti-Arrhythmia Agents; D000638:Amiodarone
keywords: Adverse effects; Amiodarone; Incidence; Risk factors