The incidence and predictors of overall adverse effects caused by low dose amiodarone in real-world clinical practice
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Background/Aims: Most current knowledge regarding amiodarone toxicity derivesfrom clinical trials. This study was performed to investigate the incidenceand risk factors of overall adverse effects of amiodarone in real-world practice usinga large sample size. Methods: Between January 1, 2000 and March 10, 2012, a total of 930 consecutivepatients who had been treated with amiodarone for arrhythmia were reviewedretrospectively. An amiodarone-associated adverse event was considered in casesof 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 durationwas 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 organtoxicities in the thyroid (2.5%), liver (2.2%), eyes (0.6%), and lungs (0.3%) wererare. All patients recovered fully without complications after amiodarone discontinuationor dose reduction. The only independent predictor of adverse effectswas 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 thisfinding.
Abstract
Background/Aims: Most current knowledge regarding amiodarone toxicity derivesfrom clinical trials. This study was performed to investigate the incidenceand risk factors of overall adverse effects of amiodarone in real-world practice usinga large sample size. Methods: Between January 1, 2000 and March 10, 2012, a total of 930 consecutivepatients who had been treated with amiodarone for arrhythmia were reviewedretrospectively. An amiodarone-associated adverse event was considered in casesof 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 durationwas 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 organtoxicities in the thyroid (2.5%), liver (2.2%), eyes (0.6%), and lungs (0.3%) wererare. All patients recovered fully without complications after amiodarone discontinuationor dose reduction. The only independent predictor of adverse effectswas 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 thisfinding.
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