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Safety Of non-Steroidal anti-inflammatory drugs

Safety Of non-Steroidal anti-inflammatory drugs

Objective

The Safety Of non-Steroidal anti-inflammatory drugs (SOS) proposal aims to assess the relative cardiovascular (CVD) and gastrointestinal (GI) safety of non-steroidal anti-inflammatory drugs (NSAIDs). The NSAIDs are divided in traditional NSAIDs (tNSAIDs) and the newer COX-II inhibitors(coxibs). The aim will be fulfilled by a two-phase approach comprising systematic reviews and synthesis of CVD and GI risk information from clinical trials and published observational studies, followed by the design and conduct of a multi-country study in existing health care databases in the UK, Netherlands, Germany and France, comprising medical information on at least 35 million persons. A data ware house will be constructed that will contain all pre-specified and locally elaborated anonimized data from inception cohorts of NSAID users. Data elaboration is standardized through a common protocol that will be designed on the basis of information and knowledge gaps observed in the systematic literature reviews, plus information requirements for the statistical and decision models. The database study will yield risk estimates for CVD and GI bleeding for each individual NSAID by dose and duration and by other important effect modifiers (e.g. aspirin use). Separate models will be built for children since the indications and dosages differ and little is known on the safety of NSAIDs in this group as they are often prescribed off-label. Special emphasis will be put on the assessment and evaluation of methodological issues, such as confounding by indication, and outcome validity as these constitute the most important threats to the interpretation, robustness and perceived validity of observational studies. The results of the literature reviews, analysis of observational databases and re-analysis of published studies will feed into a decision model for clinicians to support treatment decisions and a decision model for regulatory authorities that will focus on the public health risk.
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Coordinator

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Address

Dr Molewaterplein 40
3015 Gd Rotterdam

Netherlands

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 652 778

Administrative Contact

Sander Woerdeman (Mr.)

Participants (10)

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FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM

Spain

EU Contribution

€ 307 560

THE UNIVERSITY OF NOTTINGHAM

United Kingdom

EU Contribution

€ 124 800

UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA

Italy

EU Contribution

€ 288 180

RESEARCH TRIANGLE INSTITUTE

United States

EU Contribution

€ 325 440

UNIVERSITAET BREMEN

Germany

EU Contribution

€ 254 700

The Research Institute of the Mc Gill University Health Centre

Canada

AZIENDA OSPEDALIERA DI PADOVA

Italy

EU Contribution

€ 126 540

Stichting Informatievoorziening voor Zorg en Onderzoek

Netherlands

EU Contribution

€ 257 040

UNIVERSITE VICTOR SEGALEN BORDEAUX II

France

EU Contribution

€ 250 022

ASL DELLA PROVINCIA DI CREMONA

Italy

EU Contribution

€ 212 940

Project information

Grant agreement ID: 223495

Status

Closed project

  • Start date

    1 November 2008

  • End date

    30 April 2012

Funded under:

FP7-HEALTH

  • Overall budget:

    € 3 767 705,01

  • EU contribution

    € 2 800 000

Coordinated by:

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands