No conflict of interest was declared.
Generating signals of drug-adverse effects from prescription databases and application to the risk of arrhythmia associated with antibacterials†
Article first published online: 23 SEP 2004
Copyright © 2004 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 14, Issue 1, pages 31–40, January 2005
How to Cite
Corrao, G., Botteri, E., Bagnardi, V., Zambon, A., Carobbio, A., Falcone, C. and Leoni, O. (2005), Generating signals of drug-adverse effects from prescription databases and application to the risk of arrhythmia associated with antibacterials. Pharmacoepidem. Drug Safe., 14: 31–40. doi: 10.1002/pds.1019
- Issue published online: 13 DEC 2004
- Article first published online: 23 SEP 2004
- Manuscript Accepted: 20 AUG 2004
- Manuscript Revised: 20 MAY 2004
- Manuscript Received: 22 SEP 2003
- M.U.R.S.T. (Italian Ministry of the University and Scientific and Technologic Research) grants (portion 60% for the year 2002)
- automated databases;
- case-control design;
- cohort design;
- prescription sequence symmetry design
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.
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.
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.
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. Copyright © 2004 John Wiley & Sons, Ltd.