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Acute renal failure in patients treated with dronedarone or amiodarone: a large population-based cohort study in Italy

  • Pharmacoepidemiology and Prescription
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Abstract

Purpose

Causes of ARF are numerous including drugs. In 2012, spontaneous reporting showed a possible association between dronedarone and ARF. To further investigate such association, a retrospective cohort study on health-service claim databases was performed taking amiodarone as comparison.

Methods

All patients receiving new prescription of amiodarone or dronedarone between September 2010 and December 2012 were selected. Cox regression models to estimate the hazard ratios (HRs), with 95 % confidence intervals (CIs), for dronedarone versus amiodarone were performed. HRs were calculated: (i) for the entire cohort; (ii) for matched cohorts using propensity score; (iii) and high-dimensional propensity score.

Results

New users without previous episodes of ARF were 56,739 and 1761 on dronedarone and 54,978 on amiodarone. After 1:1 matching for propensity score, new users with dronedarone and amiodarone were 1467 and 1467, respectively. The cumulative incidence rate of ARF was 1.6 % (95 % CI 0.7–3.6 %) among dronedarone group and 2.3 % (1.0–5.1 %) among amiodarone group (p from log rank test = 0.4884). The unadjusted HR of ARF was 0.34 (0.18–0.64) in dronedarone new users compared to amiodarone; in propensity score matched cohort, it was 0.75 (0.26–2.16), and in high-dimensional propensity score, it was 0.83 (0.25–2.73).

Conclusions

This large community-based study did not confirm the signal of an increased nephrotoxicity from dronedarone compared to amiodarone. Nevertheless, given the increasing number of reports collected from pharmacovigilance databases worldwide on this association, it is advisable for clinicians and patients to be aware of the possible kidney damage due to dronedarone in order to improve clinical outcomes with early intervention.

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Acknowledgments

We thank the Pharmaceutical Departments of Lombardy and Emilia-Romagna regions for providing the data. We would also like to thank Mariagrazia Monardo, PharmD, who actively participated in this research when preparing her graduation thesis at the Unit of Pharmacology, University of Bologna.

Funding

No founding source.

Conflict of interest

The authors declare that they have no conflict of interest.

Authors’ contributions

Study conception and planning: CB, VC, DM, MV. Acquisition, analysis, or interpretation of data: CB, VC, IF, DM, MV; MM, AV, MD. Drafting of the manuscript: VC, CB, DM, MV. Critical revision of the manuscript for important intellectual content: MM, MD, IF, AV.

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Authors and Affiliations

  1. Pharmacovigilance Regional Centre of Lombardy, Via Taramelli 26, 20124, Milan, Italy

    Valentino Conti & Mauro Venegoni

  2. Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, via Irnerio 48, 40126, Bologna, Italy

    Chiara Biagi, Mauro Melis, Monia Donati, Alberto Vaccheri & Domenico Motola

  3. Operative Unit of Territorial Health Services, Regional Health Ministry, Lombardy Region, Piazza Città di Lombardia 1, 20124, Milan, Italy

    Ida Fortino

Authors
  1. Valentino Conti
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  2. Chiara Biagi
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  3. Mauro Melis
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  4. Ida Fortino
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  5. Monia Donati
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  6. Alberto Vaccheri
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  7. Mauro Venegoni
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  8. Domenico Motola
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Corresponding author

Correspondence to Domenico Motola.

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Conti, V., Biagi, C., Melis, M. et al. Acute renal failure in patients treated with dronedarone or amiodarone: a large population-based cohort study in Italy. Eur J Clin Pharmacol 71, 1147–1153 (2015). https://doi.org/10.1007/s00228-015-1903-2

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  • DOI: https://doi.org/10.1007/s00228-015-1903-2

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