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 issuesReport as inadecuate

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 - Download this document for free, or read online. Document in PDF available to download.

BMC Pediatrics

, 13:192

General pediatric medicine and surgery


BackgroundData 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.

MethodsWe 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.

ResultsThe 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.

ConclusionsPatterns 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.

KeywordsPharmacoepidemiology Database Drug utilization Health resource utilization Drug safety Sample size Asthma exacerbation Self-controlled case series design Case-crossover design AbbreviationsATCAnatomical therapeutic chemical classification system

BNFBritish national formulary


DDDDefined daily dose

DWData warehouse

EMAEuropean medicines agency

EUEuropean union

FDAU.S. Food and drug administration

FPFamily pediatrician-Office-based pediatrician


GePaRDGerman pharmacoepidemiological research database

GPGeneral practitioner-family physician

ICHInternational conference of harmonization

IPCIIntegrated primary care information project


NLThe Netherlands

NSAIDNon-steroidal anti-inflammatory drug

OSSIFFOsservatorio Interaziendale per la Farmacoepidemiologia e la Farmacoeconomia

PYPerson-years a commonly used denominator correcting for incomplete participation of individual patients

SAESerious adverse event

SISRSistema informativo sanitario regionale Regional Health Informative System

THINThe health improvement network

UKUnited Kingdom

WHOWorld health organization of the united nations UN.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2431-13-192 contains supplementary material, which is available to authorized users.

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Author: Vera E Valkhoff - René Schade - Geert W ‘t Jong - Silvana Romio - Martijn J Schuemie - Andrea Arfe - Edeltraut Garbe

Source: https://link.springer.com/


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