Korean J Intern Med.  2014 Sep;29(5):588-596. 10.3904/kjim.2014.29.5.588.

The incidence and predictors of overall adverse effects caused by low dose amiodarone in real-world clinical practice

• Kim HL
• Seo JB
• Chung WY
• Kim SH
• Kim MA
• Zo JH

• KMID: 1794623
• DOI: http://doi.org/10.3904/kjim.2014.29.5.588

Abstract

BACKGROUND/AIMS
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.

Keyword

Adverse effects; Amiodarone; Incidence; Risk factors

MeSH Terms

Aged
Amiodarone/administration & dosage/*adverse effects
Anti-Arrhythmia Agents/administration & dosage/*adverse effects
Arrhythmias, Cardiac/drug therapy
Atrioventricular Block/chemically induced/epidemiology
Bradycardia/chemically induced/epidemiology
Female
Humans
Incidence
Male
Middle Aged
Republic of Korea
Retrospective Studies
Risk Factors
Amiodarone
Anti-Arrhythmia Agents