Objectif 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. Champ scientifique medical and health scienceshealth scienceshealth care serviceseHealthmedical and health scienceshealth sciencespublic healthnatural sciencescomputer and information sciencesdatabases Mots‑clés NSAIDs cardiovascular databases decision model gastrointestinal observational risk Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Thème(s) HEALTH-2007-4.2-2 - Relative safety of non-steroidal anti-inflammatory drugs (NSAIDs) Appel à propositions FP7-HEALTH-2007-B Voir d’autres projets de cet appel Régime de financement CP-FP - Small or medium-scale focused research project Coordinateur ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM Contribution de l’UE € 652 778,00 Adresse DR MOLEWATERPLEIN 40 3015 GD Rotterdam Pays-Bas Voir sur la carte Région West-Nederland Zuid-Holland Groot-Rijnmond Type d’activité Higher or Secondary Education Establishments Contact administratif Sander Woerdeman (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée Participants (10) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire FUNDACIO INSTITUT HOSPITAL DEL MAR D INVESTIGACIONS MEDIQUES Espagne Contribution de l’UE € 307 560,00 Adresse Doctor Aiguader 88 08003 Barcelona Voir sur la carte Région Este Cataluña Barcelona Type d’activité Research Organisations Contact administratif Carlos Díaz Acedo (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée THE UNIVERSITY OF NOTTINGHAM Royaume-Uni Contribution de l’UE € 124 800,00 Adresse University Park NG7 2RD Nottingham Voir sur la carte Région East Midlands (England) Derbyshire and Nottinghamshire Nottingham Type d’activité Higher or Secondary Education Establishments Contact administratif Paul Cartledge (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA Italie Contribution de l’UE € 288 180,00 Adresse PIAZZA DELL'ATENEO NUOVO 1 20126 MILANO Voir sur la carte Région Nord-Ovest Lombardia Milano Type d’activité Higher or Secondary Education Establishments Contact administratif Gianpiero Latino (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée RESEARCH TRIANGLE INSTITUTE États-Unis Contribution de l’UE € 325 440,00 Adresse CORNWALLIS ROAD 3040 27709 Research Triangle Park Voir sur la carte Type d’activité Research Organisations Contact administratif Carla Franzoni Grau (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée UNIVERSITAET BREMEN Allemagne Contribution de l’UE € 254 700,00 Adresse Bibliothekstrasse 1 28359 Bremen Voir sur la carte Région Bremen Bremen Bremen, Kreisfreie Stadt Type d’activité Higher or Secondary Education Establishments Contact administratif Wolfgang Banasiewicz (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée The Research Institute of the Mc Gill University Health Centre Canada Contribution de l’UE Aucune donnée Adresse GUY STREET 2155 H3H 2R9 Montreal Voir sur la carte Type d’activité Research Organisations Contact administratif Sasha Lee (Ms.) Liens Contacter l’organisation Opens in new window Coût total Aucune donnée AZIENDA OSPEDALE UNIVERSITA PADOVA Italie Contribution de l’UE € 126 540,00 Adresse VIA NICOLO GIUSTINIANI 1 35128 Padova Voir sur la carte Région Nord-Est Veneto Padova Type d’activité Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contact administratif Antonio Giona (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée Stichting Informatievoorziening voor Zorg en Onderzoek Pays-Bas Contribution de l’UE € 257 040,00 Adresse Van Deventerlaan 3528AE Utrecht Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Heleen Van Engeland (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée UNIVERSITE VICTOR SEGALEN BORDEAUX II France Contribution de l’UE € 250 022,00 Adresse RUE LEO SAIGNAT 146 33076 BORDEAUX CEDEX Voir sur la carte Type d’activité Higher or Secondary Education Establishments Contact administratif Nicholas Moore (Prof.) Liens Contacter l’organisation Opens in new window Coût total Aucune donnée ASL DELLA PROVINCIA DI CREMONA Italie Contribution de l’UE € 212 940,00 Adresse Via dei Toscani 46100 Mantova Voir sur la carte Type d’activité Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contact administratif Giuseppe Albini (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée
