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Effect of Macrolide and Fluoroquinolone Antibacterials on the Risk of Ventricular Arrhythmia and Cardiac Arrest

An Observational Study in Italy Using Case-Control, Case-Crossover and Case-Time-Control Designs

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Abstract

Objective: To compare the effect of macrolide and fluoroquinolone antibacterials on the onset of ventricular arrhythmia and cardiac arrest using three different observational designs.

Methods: A population-based case-control study was performed by linking automated databases from the Varese Province of Italy. Cases were all subjects who experienced ventricular arrhythmia or cardiac arrest from July 1998 to December 2003. For each case, up to ten controls were randomly selected after matching for sex, age, practitioner and date of arrhythmia onset. The use of macrolides and fluoroquinolones during two time windows denoted as recent and referent intervals was ascertained. Odds ratios were estimated using case-control, case-crossover and case-time-control approaches.

Results: 1275 cases and 9189 controls met the inclusion criteria. Adjusted odds ratios (and corresponding 95% CIs) associated with recent exposure to macrolides were 2.13 (1.34, 3.39), 1.70 (0.88, 3.26) and 1.62 (0.78, 3.34) by using case-control, case-crossover and case-time-control designs, respectively. The corresponding estimates for fluoroquinolones were 3.58 (2.51, 5.12), 1.98 (1.19, 3.29) and 1.59 (0.88, 2.87), respectively.

Conclusions: Three observational study designs each using entirely different sets of controls consistently showed that recent use of macrolide and fluoro-quinolone antibacterials may be associated with increased risk of ventricular arrhythmia and cardiac arrest.

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Acknowledgements

Support for this study was received from the M.I.U.R. (Italian Ministry of the Instruction, University and Research) grants (“Fondo d’Ateneo per la Ricerca” portion, year 2005, and PRIN portion, protocol n∘ 2005068001, year 2005). The authors have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Unit of Biostatistics and Epidemiology, Department of Statistics, University of Milan-Bicocca, Milan, Italy

    Antonella Zambon & Giovanni Corrao

  2. Department of Emergency, Urgency Merate Hospital, Merate, Italy

    Hernan Polo

  3. Cancer Registry of the province of Varese, Lombardia, Milan, Italy

    Paolo Contiero

Authors
  1. Antonella Zambon
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  2. Hernan Polo
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  3. Paolo Contiero
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  4. Giovanni Corrao
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Correspondence to Antonella Zambon.

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Zambon, A., Polo, H., Contiero, P. et al. Effect of Macrolide and Fluoroquinolone Antibacterials on the Risk of Ventricular Arrhythmia and Cardiac Arrest. Drug-Safety 32, 159–167 (2009). https://doi.org/10.2165/00002018-200932020-00008

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  • DOI: https://doi.org/10.2165/00002018-200932020-00008

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