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Research

Use of azithromycin and risk of ventricular arrhythmia

Gianluca Trifirò, Maria de Ridder, Janet Sultana, Alessandro Oteri, Peter Rijnbeek, Serena Pecchioli, Giampiero Mazzaglia, Irene Bezemer, Edeltraut Garbe, Tania Schink, Elisabetta Poluzzi, Trine Frøslev, Mariam Molokhia, Igor Diemberger and Miriam C.J.M. Sturkenboom
CMAJ April 18, 2017 189 (15) E560-E568; DOI: https://doi.org/10.1503/cmaj.160355
Gianluca Trifirò
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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  • For correspondence: trifirog@unime.it
Maria de Ridder
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Janet Sultana
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Alessandro Oteri
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Peter Rijnbeek
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Serena Pecchioli
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Giampiero Mazzaglia
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Irene Bezemer
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Edeltraut Garbe
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Tania Schink
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Elisabetta Poluzzi
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Trine Frøslev
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Mariam Molokhia
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Igor Diemberger
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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Miriam C.J.M. Sturkenboom
Department of Medical Informatics (Trifirò, de Ridder, Sultana, Oteri, Rijnbeek, Sturkenboom), Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biomedical and Dental Sciences and Morpho-functional Imaging (Trifirò), and Department of Clinical and Experimental Medicine (Sultana), University of Messina, Messina, Italy; Health Search, Italian College of General Practitioners (Pecchioli, Mazzaglia), Florence, Italy; PHARMO Institute for Drug Outcomes Research (Bezemer), Utrecht, Netherlands; Leibniz Institute for Prevention Research and Epidemiology — BIPS GmbH (Garbe, Schink), Bremen, Germany; Department of Medical and Surgical Sciences (Poluzzi), University of Bologna, Bologna, Italy; Department of Clinical Epidemiology (Frøslev), Aarhus University Hospital, Aarhus, Denmark; Department of Primary Care and Public Health Sciences (Molokhia), King’s College, London, United Kingdom; Department of Experimental, Diagnostic and Specialty Medicine (Diemberger), University of Bologna, Bologna, Italy
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  • Figure 1:
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    Figure 1:

    Selection of study cohort from 7 databases. AARHUS = Aarhus University Hospital Database, ERD = Emilia-Romagna Database, GePaRD = German Pharmacoepidemiological Research Database, HSD-CSD-LPD = Health Search Database Cegedim Strategic Data Longitudinal Patient Database, IPCI = Integrated Primary Care Information, PHARMO = PHARMO Database Network, THIN = The Health Improvement Network.

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    Figure 2:

    Database-specific risk of ventricular arrhythmia associated with current use of azithromycin compared with current use of amoxicillin (2-stage random-effects model). Values greater than 1.0 indicate an increased risk of ventricular arrhythmia with use of azithromycin (values plotted on logarithmic scale). Cochran Q = 0.08; p = 0.1; I2 = 51%. CI = confidence interval, OR = odds ratio. *Databases with fewer than 3 exposed cases were not included in the model.

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    Figure 3:

    Database-specific risk of ventricular arrhythmia associated with current use of azithromycin versus nonuse of antibiotics (2-stage random-effects model). Values greater than 1.0 indicate an increased risk of ventricular arrhythmia with use of azithromycin (values plotted on logarithmic scale). Cochran Q = 3.4; p = 0.3; I2 = 11.4%. CI = confidence interval, OR = odds ratio. *Databases with fewer than 3 exposed cases were not included in the model.

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    Table 1:

    Features of the databases included in the study

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    Table 2:

    Demographic and clinical characteristics of ventricular arrhythmia cases and matched controls in an inception cohort of new users of antibiotics across all databases (1-stage pooling)

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    Table 3:

    Risk of ventricular arrhythmia associated with current, recent and past use of azithromycin compared with current use of amoxicillin (1-stage pooling)

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    Table 4:

    Risk of ventricular arrhythmia associated with current, recent and past use of azithromycin and other antibiotics compared with nonuse of antibiotics (1-stage pooling)

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Canadian Medical Association Journal: 189 (15)
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Vol. 189, Issue 15
18 Apr 2017
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Use of azithromycin and risk of ventricular arrhythmia
Gianluca Trifirò, Maria de Ridder, Janet Sultana, Alessandro Oteri, Peter Rijnbeek, Serena Pecchioli, Giampiero Mazzaglia, Irene Bezemer, Edeltraut Garbe, Tania Schink, Elisabetta Poluzzi, Trine Frøslev, Mariam Molokhia, Igor Diemberger, Miriam C.J.M. Sturkenboom
CMAJ Apr 2017, 189 (15) E560-E568; DOI: 10.1503/cmaj.160355

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Use of azithromycin and risk of ventricular arrhythmia
Gianluca Trifirò, Maria de Ridder, Janet Sultana, Alessandro Oteri, Peter Rijnbeek, Serena Pecchioli, Giampiero Mazzaglia, Irene Bezemer, Edeltraut Garbe, Tania Schink, Elisabetta Poluzzi, Trine Frøslev, Mariam Molokhia, Igor Diemberger, Miriam C.J.M. Sturkenboom
CMAJ Apr 2017, 189 (15) E560-E568; DOI: 10.1503/cmaj.160355
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