No funding was received for this study
Representativeness of diabetes patients participating in a web-based adverse drug reaction monitoring system
Article first published online: 30 AUG 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 22, Issue 3, pages 250–255, March 2013
How to Cite
Härmark, L., Alberts, S., van Puijenbroek, E., Denig, P. and van Grootheest, K. (2013), Representativeness of diabetes patients participating in a web-based adverse drug reaction monitoring system. Pharmacoepidem. Drug Safe., 22: 250–255. doi: 10.1002/pds.3341
No ethical approval was necessary for this study
- Issue published online: 1 MAR 2013
- Article first published online: 30 AUG 2012
- Manuscript Accepted: 2 AUG 2012
- Manuscript Revised: 27 JUL 2012
- Manuscript Received: 21 MAR 2012
- adverse drug reaction;
- intensive monitoring;
- diabetes population;
Lareb Intensive Monitoring, LIM, is a non-interventional observational cohort method which follows first-time users of certain drugs during a certain period of time and collects information about adverse drug reactions, ADRs. In order for LIM to be a useful pharmacovigilance tool, it is important to know whether the LIM population is comparable to the whole population using the drug.
The aim of this study is to compare the LIM diabetes population with an external diabetes reference population on characteristics that may influence the patient's susceptibility for ADRs.
In this study, a LIM diabetes population was compared to a reference diabetes population derived from The Groningen Initiative to ANalyse Type 2 diabetes Treatment project. Comparisons were made regarding age, gender, body mass index and polypharmacy, as well as diabetes medication used and disease/treatment duration.
LIM patients were more often men (58.5% vs 50.8%) and in general younger (59.1 vs 64.7 years) and healthier, by that meaning they had a higher percentage of de novo treated patients (55.5% vs 53.2%), a shorter diabetes treatment duration (3.7 vs 5.5 years) and used less co-medication than patients in the reference population.
This study shows that diabetes patients participating in a web-based intensive monitoring system differ from a reference population. The observed differences might lead to an underestimation of ADRs, but it is not clear whether this would also influence the type or time-course of the reported ADRs. When interpreting results from LIM studies, one should take these differences into account. Copyright © 2012 John Wiley & Sons, Ltd.