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Safety Of non-Steroidal anti-inflammatory drugs

Objetivo

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.

Ámbito científico

  • /ciencias naturales/informática y ciencias de la información/base de datos
  • /ciencias médicas y de la salud/ciencias de la salud/salud pública y medio ambiental
  • /ciencias médicas y de la salud/ciencias de la salud/asistencia sanitaria/sanidad electrónica
  • /humanidades/lenguas y literatura/literatura - general

Convocatoria de propuestas

FP7-HEALTH-2007-B
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Régimen de financiación

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

Coordinador

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Dirección
Dr Molewaterplein 40
3015 GD Rotterdam
Países Bajos
Tipo de actividad
Higher or Secondary Education Establishments
Aportación de la UE
€ 652 778
Contacto administrativo
Sander Woerdeman (Mr.)

Participantes (10)

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