Representativeness of diabetes patients participating in a web-based adverse drug reaction monitoring system

作者: Linda Härmark , Susanne Alberts , Eugène van Puijenbroek , Petra Denig , Kees van Grootheest

DOI: 10.1002/PDS.3341

关键词:

摘要: Purpose Lareb Intensive Monitoring, LIM, is a non-interventional observational cohort method which follows first-time users of certain drugs during period time and collects information about adverse drug reactions, ADRs. In order for LIM to be useful pharmacovigilance tool, it important know whether the population comparable whole using drug. The aim this study compare diabetes with an external reference on characteristics that may influence patient’s susceptibility Methods study, was compared derived from Groningen Initiative ANalyse Type 2 Treatment project. Comparisons were made regarding age, gender, body mass index polypharmacy, as well medication used disease/treatment duration. Results patients more often men (58.5% vs 50.8%) in general younger (59.1 64.7 years) healthier, by meaning they had higher percentage de novo treated (55.5% 53.2%), shorter treatment duration (3.7 5.5 less co-medication than population. Conclusions This shows participating web-based intensive monitoring system differ observed differences might lead underestimation ADRs, but not clear would also type or time-course reported When interpreting results studies, one should take these into account. Copyright © 2012 John Wiley & Sons, Ltd. key words—pharmacovigilance; reaction; monitoring; web; population; pharmacoepidemiology

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