Generating signals of drug-adverse effects from prescription databases and application to the risk of arrhythmia associated with antibacterials

Giovanni Corrao, Edoardo Botteri, Vincenzo Bagnardi, Antonella Zambon, Alessandra Carobbio, Chiara Falcone, Olivia Leoni

Research output: Contribution to journalArticle

Abstract

Background. Although it is well known that a variety of antibacterials may incidentally cause malignant arrhythmia, the list of drugs causing arrhythmia and the impact of these adverse effects are still uncertain. We investigated on this topic by using a large prescription database with different observational designs. Methods. Prescription data on all incident users of several antibacterial and antiarrhythmic drugs over the period July 1997 through December 1999 were retrieved from the Drug Prescription Database (DPD) of the Italian Province of Varese. The association between the use of antibacterial and antiarrhythmic drugs was investigated by applying prescription sequence symmetry, cohort and nested case-control designs. Results. Lower proarrhythmic effects were on an average obtained from prescription sequence symmetry approach with respect to both cohort and nested case-control. Evidence of association between exposure to drugs (erythromycin and ciprofloxacin) and the risk of arrhythmia. was consistently found by the three approaches. No other signals were generated from the prescription sequence symmetry analysis. Two drugs (clarithromycin and levofloxacin) showed patterns compatible with an arrhythmic effect according to both cohort and nested case-control designs. Conclusions. Prescription databases are useful tools to explore drug safety through both conventional and emerging observational designs. In spite of its appealing features, prescription sequence symmetry design shows lower sensitivity with respect to conventional designs. Evidence about the association between the use of certain macrolides and fluoroquinolones and the onset of arrhythmia is confirmed by this study.

Original languageEnglish
Pages (from-to)31-40
Number of pages10
JournalPharmacoepidemiology and Drug Safety
Volume14
Issue number1
DOIs
Publication statusPublished - Jan 2005

Keywords

  • Antibacterials
  • Arrhythmia
  • Automated databases
  • Case-control design
  • Cohort design
  • Fluoroquinolones
  • Macrolides
  • Prescription sequence symmetry design

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Fingerprint Dive into the research topics of 'Generating signals of drug-adverse effects from prescription databases and application to the risk of arrhythmia associated with antibacterials'. Together they form a unique fingerprint.

  • Cite this