The incidence and predictors of overall adverse effects caused by low dose amiodarone in real-world clinical practice.
10.3904/kjim.2014.29.5.588
- Author:
Hack Lyoung KIM
1
;
Jae Bin SEO
;
Woo Young CHUNG
;
Sang Hyun KIM
;
Myung A KIM
;
Joo Hee ZO
Author Information
1. Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. jooheezo@hanmail.net
- Publication Type:Original Article
- Keywords:
Adverse effects;
Amiodarone;
Incidence;
Risk factors
- MeSH:
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
- From:The Korean Journal of Internal Medicine
2014;29(5):588-596
- CountryRepublic of Korea
- Language:English
-
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.
