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. Fields of science medical and health scienceshealth scienceshealth care serviceseHealthmedical and health scienceshealth sciencespublic healthnatural sciencescomputer and information sciencesdatabases Keywords NSAIDs cardiovascular databases decision model gastrointestinal observational risk Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH-2007-4.2-2 - Relative safety of non-steroidal anti-inflammatory drugs (NSAIDs) 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 See on map Region West-Nederland Zuid-Holland Groot-Rijnmond Activity type Higher or Secondary Education Establishments Administrative Contact Sander Woerdeman (Mr.) Links Contact the organisation Opens in new window Website Opens in new window EU contribution € 652 778,00 Participants (10) Sort alphabetically Sort by EU Contribution Expand all Collapse all FUNDACIO INSTITUT HOSPITAL DEL MAR D INVESTIGACIONS MEDIQUES Spain EU contribution € 307 560,00 Address Doctor aiguader 88 08003 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Administrative Contact Carlos Díaz Acedo (Mr.) Links Contact the organisation Opens in new window Website Opens in new window THE UNIVERSITY OF NOTTINGHAM United Kingdom EU contribution € 124 800,00 Address University park NG7 2RD Nottingham See on map Region East Midlands (England) Derbyshire and Nottinghamshire Nottingham Activity type Higher or Secondary Education Establishments Administrative Contact Paul Cartledge (Mr.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA Italy EU contribution € 288 180,00 Address Piazza dell'ateneo nuovo 1 20126 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Higher or Secondary Education Establishments Administrative Contact Gianpiero Latino (Mr.) Links Contact the organisation Opens in new window Website Opens in new window RESEARCH TRIANGLE INSTITUTE United States EU contribution € 325 440,00 Address Cornwallis road 3040 27709 Research triangle park See on map Activity type Research Organisations Administrative Contact Carla Franzoni Grau (Ms.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITAET BREMEN Germany EU contribution € 254 700,00 Address Bibliothekstrasse 1 28359 Bremen See on map Region Bremen Bremen Bremen, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Administrative Contact Wolfgang Banasiewicz (Mr.) Links Contact the organisation Opens in new window Website Opens in new window The Research Institute of the Mc Gill University Health Centre Canada EU contribution € 0,00 Address Guy street 2155 H3H 2R9 Montreal See on map Activity type Research Organisations Administrative Contact Sasha Lee (Ms.) Links Contact the organisation Opens in new window AZIENDA OSPEDALE UNIVERSITA PADOVA Italy EU contribution € 126 540,00 Address Via nicolo giustiniani 1 35128 Padova See on map Region Nord-Est Veneto Padova Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Antonio Giona (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Stichting Informatievoorziening voor Zorg en Onderzoek Netherlands EU contribution € 257 040,00 Address Van deventerlaan 3528AE Utrecht See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Heleen Van Engeland (Ms.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITE VICTOR SEGALEN BORDEAUX II France EU contribution € 250 022,00 Address Rue leo saignat 146 33076 Bordeaux cedex See on map Activity type Higher or Secondary Education Establishments Administrative Contact Nicholas Moore (Prof.) Links Contact the organisation Opens in new window ASL DELLA PROVINCIA DI CREMONA Italy EU contribution € 212 940,00 Address Via dei toscani 46100 Mantova See on map Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Giuseppe Albini (Dr.) Links Contact the organisation Opens in new window Website Opens in new window
