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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.

Field of science

  • /natural sciences/computer and information sciences/databases
  • /medical and health sciences/health sciences/public and environmental health
  • /medical and health sciences/health sciences/health care services/ehealth
  • /humanities/languages and literature/literature - general

Call for proposal

FP7-HEALTH-2007-B
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

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)

FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM
Spain
EU contribution
€ 307 560
Address
Doctor Aiguader 88
08003 Barcelona
Activity type
Research Organisations
Administrative Contact
Carlos Díaz Acedo (Mr.)
THE UNIVERSITY OF NOTTINGHAM
United Kingdom
EU contribution
€ 124 800
Address
University Park
NG7 2RD Nottingham
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Cartledge (Mr.)
UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA
Italy
EU contribution
€ 288 180
Address
Piazza Dell'ateneo Nuovo 1
20126 Milano
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gianpiero Latino (Mr.)
RESEARCH TRIANGLE INSTITUTE
United States
EU contribution
€ 325 440
Address
Cornwallis Road 3040
27709 Research Triangle Park
Activity type
Research Organisations
Administrative Contact
Carla Franzoni Grau (Ms.)
UNIVERSITAET BREMEN
Germany
EU contribution
€ 254 700
Address
Bibliothekstrasse 1
28359 Bremen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wolfgang Banasiewicz (Mr.)
The Research Institute of the Mc Gill University Health Centre
Canada
Address
Guy Street 2155
H3H 2R9 Montreal
Activity type
Research Organisations
Administrative Contact
Sasha Lee (Ms.)
AZIENDA OSPEDALE UNIVERSITA PADOVA
Italy
EU contribution
€ 126 540
Address
Via Nicolo Giustiniani 1
35128 Padova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Antonio Giona (Dr.)
Stichting Informatievoorziening voor Zorg en Onderzoek
Netherlands
EU contribution
€ 257 040
Address
Van Deventerlaan
3528AE Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Heleen Van Engeland (Ms.)
UNIVERSITE VICTOR SEGALEN BORDEAUX II
France
EU contribution
€ 250 022
Address
Rue Leo Saignat 146
33076 Bordeaux Cedex
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nicholas Moore (Prof.)
ASL DELLA PROVINCIA DI CREMONA
Italy
EU contribution
€ 212 940
Address
Via Dei Toscani
46100 Mantova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Giuseppe Albini (Dr.)