Amiodarone and the risk of cancer

A nationwide population-based study

Authors

  • Vincent Yi-Fong Su MD,

    1. Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
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    • The first 2 authors contributed equally to this article.

  • Yu-Wen Hu MD,

    1. Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan
    2. School of Medicine, National Yang-Ming University, Taipei, Taiwan
    3. Institute of Public Health, National Yang-Ming University, Taipei, Taiwan
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    • The first 2 authors contributed equally to this article.

  • Kun-Ta Chou MD,

    1. Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
    2. School of Medicine, National Yang-Ming University, Taipei, Taiwan
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  • Shuo-Ming Ou MD,

    1. Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
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  • Yu-Chin Lee PhD,

    1. Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
    2. School of Medicine, National Yang-Ming University, Taipei, Taiwan
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  • Elizabeth Ya-Hsuan Lin BSc,

    1. College of Medicine, Chang Gung University, Taoyuan, Taiwan
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  • Tzeng-Ji Chen PhD,

    1. School of Medicine, National Yang-Ming University, Taipei, Taiwan
    2. Department of Family Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
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  • Cheng-Hwai Tzeng PhD,

    1. School of Medicine, National Yang-Ming University, Taipei, Taiwan
    2. Division of Hematology and Oncology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
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  • Chia-Jen Liu MD

    Corresponding author
    1. School of Medicine, National Yang-Ming University, Taipei, Taiwan
    2. Institute of Public Health, National Yang-Ming University, Taipei, Taiwan
    3. Division of Hematology and Oncology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
    4. Department of Internal Medicine, National Yang-Ming University Hospital, Yilan, Taiwan
    • Department of Hematology and Oncology, Department of Medicine, Taipei Veterans General Hospital No. 201, Shih-Pai Rd, Sec. 2,Taipei, Taiwan

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    • Fax: (011) 886 2-28757762


  • 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.

Abstract

BACKGROUND:

In postmarketing surveillance, the US Food and Drug Administration has reported the development of lung masses, thyroid cancer, and skin cancer after amiodarone therapy.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

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