Valkhoff-et-al_2013_Popultion-based analysis.pdf 515,52KB
1000 Titel
  • Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues?
1000 Autor/in
  1. Valkhoff, Vera E. |
  2. Schade, René |
  3. 't Jong, Geert W. |
  4. Romio, Silvana |
  5. Schuemie, Martijn J. |
  6. Arfè, Andrea |
  7. Garbe, Edeltraut |
  8. Herings, Ron |
  9. Lucchi, Silvia |
  10. Picelli, Gino |
  11. Schink, Tania |
  12. Straatman, Huub |
  13. Villa, Marco |
  14. Kuipers, Ernst J. |
  15. Sturkenboom, Miriam C. J. M. |
1000 Mitwirkende/r
  1. The Safety of Non-steroidal Anti-inflammatory Drugs (SOS) project |
1000 Erscheinungsjahr 2013
1000 LeibnizOpen
1000 Art der Datei
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2013-11-19
1000 Erschienen in
1000 Quellenangabe
  • 13:192
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2013
1000 Lizenz
1000 Verlagsversion
  • |
  • |
1000 Ergänzendes Material
  • |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • BACKGROUND: Data on utilization patterns and safety of non-steroidal anti-inflammatory drugs (NSAIDs) in children are scarce. The purpose of this study was to investigate the utilization of NSAIDs among children in four European countries as part of the Safety Of non-Steroidal anti-inflammatory drugs (SOS) project. METHODS: We used longitudinal patient data from seven databases (GePaRD, IPCI, OSSIFF, Pedianet, PHARMO, SISR, and THIN) to calculate prevalence rates of NSAID use among children (0–18 years of age) from Germany, Italy, Netherlands, and United Kingdom. All databases contained a representative population sample and recorded demographics, diagnoses, and drug prescriptions. Prevalence rates of NSAID use were stratified by age, sex, and calendar time. The person-time of NSAID exposure was calculated by using the duration of the prescription supply. We calculated incidence rates for serious adverse events of interest. For these adverse events of interest, sample size calculations were conducted (alpha = 0.05; 1-beta = 0.8) to determine the amount of NSAID exposure time that would be required for safety studies in children. RESULTS: The source population comprised 7.7 million children with a total of 29.6 million person-years of observation. Of those, 1.3 million children were exposed to at least one of 45 NSAIDs during observation time. Overall prevalence rates of NSAID use in children differed across countries, ranging from 4.4 (Italy) to 197 (Germany) per 1000 person-years in 2007. For Germany, United Kingdom, and Italian pediatricians, we observed high rates of NSAID use among children aged one to four years. For all four countries, NSAID use increased with older age categories for children older than 11. In this analysis, only for ibuprofen (the most frequently used NSAID), enough exposure was available to detect a weak association (relative risk of 2) between exposure and asthma exacerbation (the most common serious adverse event of interest). CONCLUSIONS: Patterns of NSAID use in children were heterogeneous across four European countries. The SOS project platform captures data on more than 1.3 million children who were exposed to NSAIDs. Even larger data platforms and the use of advanced versions of case-only study designs may be needed to conclusively assess the safety of these drugs in children.
1000 Sacherschließung
lokal Pharmacoepidemiology
lokal Sample size
lokal Drug utilization
lokal Database
lokal Self-controlled case series design
lokal Health resource utilization
lokal Asthma exacerbation
lokal Case-crossover design
lokal Drug safety
1000 Fachgruppe
  1. Medizin |
  2. Gesundheitswesen |
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
1000 Label
1000 Förderer
  1. European Community |
1000 Fördernummer
  1. 223495
1000 Förderprogramm
  1. Seventh Framework Programme
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer European Community |
    1000 Förderprogramm Seventh Framework Programme
    1000 Fördernummer 223495
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6407496.rdf
1000 Erstellt am 2018-04-09T12:35:09.366+0200
1000 Erstellt von 266
1000 beschreibt frl:6407496
1000 Bearbeitet von 25
1000 Zuletzt bearbeitet Thu Jan 30 18:52:58 CET 2020
1000 Objekt bearb. Tue Apr 10 09:01:36 CEST 2018
1000 Vgl. frl:6407496
1000 Oai Id
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1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

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