Generating signals of drug‐adverse effects from prescription databases and application to the risk of arrhythmia associated with antibacterials
- 13 December 2004
- journal article
- research article
- Published by Wiley in Pharmacoepidemiology and Drug Safety
- Vol. 14 (1), 31-40
- https://doi.org/10.1002/pds.1019
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. Copyright © 2004 John Wiley & Sons, Ltd.Keywords
This publication has 22 references indexed in Scilit:
- Long QT syndrome caused by noncardiac drugsProgress in Cardiovascular Diseases, 2003
- Divergent Proarrhythmic Potential of Macrolide Antibiotics Despite Similar QT Prolongation: Fast Phase 3 Repolarization Prevents Early Afterdepolarizations and Torsade de PointesJournal of Pharmacology and Experimental Therapeutics, 2002
- Sifting the evidence---what's wrong with significance tests? Another comment on the role of statistical methodsBMJ, 2001
- Profiles of Hepatic and Dysrhythmic Cardiovascular Events Following Use of Fluoroquinolone AntibacterialsDrug Safety, 2001
- The risk of acute pancreatitis associated with acid‐suppressing drugsBritish Journal of Clinical Pharmacology, 2000
- ‘Unqualified Success’ and ‘Unmitigated Failure’ Number-Needed-to-Treat-Related Concepts for Assessing Treatment Efficacy in the Presence of Treatment-Induced Adverse EventsInternational Journal of Epidemiology, 1996
- Channeling bias in the interpretation of drug effectsStatistics in Medicine, 1991
- Rapid method for estimating the risk of acutely controversial side effects of prescription drugsJournal of Clinical Epidemiology, 1990
- Prescription sequence analysis: A new and fast method for assessing certain adverse reactions of prescription drugs in large populationsStatistics in Medicine, 1988