The first 2 authors contributed equally to this article.
Amiodarone and the risk of cancer†
A nationwide population-based study
Version of Record online: 8 APR 2013
Copyright © 2012 American Cancer Society
Volume 119, Issue 9, pages 1699–1705, 1 May 2013
How to Cite
Su, V. Y.-F., Hu, Y.-W., Chou, K.-T., Ou, S.-M., Lee, Y.-C., Lin, E. Y.-H., Chen, T.-J., Tzeng, C.-H. and Liu, C.-J. (2013), Amiodarone and the risk of cancer. Cancer, 119: 1699–1705. doi: 10.1002/cncr.27881
The study is based in part on data from the National Health Insurance Research Database provided by the Bureau of National Health Insurance, Department of Health and managed by National Health Research Institutes. The interpretation and conclusions contained herein do not represent those of Bureau of National Health Insurance, Department of Health, or National Health Research Institutes.
- Issue online: 22 APR 2013
- Version of Record online: 8 APR 2013
- Manuscript Accepted: 26 SEP 2012
- Manuscript Revised: 16 SEP 2012
- Manuscript Received: 26 JUN 2012
- thyroid cancer;
- lung cancer
In postmarketing surveillance, the US Food and Drug Administration has reported the development of lung masses, thyroid cancer, and skin cancer after amiodarone therapy.
Using the Taiwan National Health Insurance Research database, the authors conducted a population-based cohort study. Patients who were treated with amiodarone between 1997 and 2008 were enrolled. Those with antecedent cancer were excluded. Standardized incidence ratios (SIRs) of cancers were calculated to compare the cancer incidence of the study cohort with that of the general population. A multivariate Cox regression model was used to evaluate the association between cumulative defined daily doses (cDDDs) of amiodarone and cancer occurrence.
The study included 6418 subjects, with a median follow-up of 2.57 years. A total of 280 patients developed cancer. The risk of cancer increased with borderline significance (SIR, 1.12; 95% confidence interval [95% CI], 0.99-1.26 [P = .067]). Male patients had a higher risk (SIR, 1.18; 95% CI, 1.02-1.36 [P = .022]). The total cohort of patients and the male patients with > 180 cDDDs within the first year were found to have SIRs of 1.28 (95% CI, 1.00-1.61; P = .046) and 1.46 (95% CI, 1.11-1.89; P = .008), respectively. After adjustment for age, sex, and comorbidities, the hazards ratio was 1.98 (95% CI, 1.22-3.22; P = .006) for the high tertile of cDDDs compared with the low tertile.
The results of the current study indicate that amiodarone may be associated with an increased risk of incident cancer, especially in males, with a dose-dependent effect. Cancer 2013;119:1699–1705. © 2013 American Cancer Society.