SOS

Safety Of non-Steroidal anti-inflammatory drugs

 Coordinatore ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM 

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Mr.
Nome: Sander
Cognome: Woerdeman
Email: send email
Telefono: +31 10 7043049
Fax: +31 10 4089447

 Nazionalità Coordinatore Netherlands [NL]
 Totale costo 3˙767˙705 €
 EC contributo 2˙800˙000 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2007-B
 Funding Scheme CP-FP
 Anno di inizio 2008
 Periodo (anno-mese-giorno) 2008-11-01   -   2012-04-30

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Mr.
Nome: Sander
Cognome: Woerdeman
Email: send email
Telefono: +31 10 7043049
Fax: +31 10 4089447

NL (ROTTERDAM) coordinator 652˙778.00
2    RESEARCH TRIANGLE INSTITUTE

 Organization address address: CORNWALLIS ROAD 3040
city: RESEARCH TRIANGLE PARK
postcode: 27709

contact info
Titolo: Ms.
Nome: Carla
Cognome: Franzoni Grau
Email: send email
Telefono: +34 93 241 7766
Fax: +34 93 414 2610

US (RESEARCH TRIANGLE PARK) participant 325˙440.00
3    FUNDACIO IMIM

 Organization address address: Doctor Aiguader 88
city: BARCELONA
postcode: 8003

contact info
Titolo: Mr.
Nome: Carlos
Cognome: Díaz Acedo
Email: send email
Telefono: +34 93 316 0518
Fax: +34 93 316 0550

ES (BARCELONA) participant 307˙560.00
4    UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA

 Organization address address: PIAZZA DELL'ATENEO NUOVO 1
city: MILANO
postcode: IT-20126

contact info
Titolo: Mr.
Nome: Gianpiero
Cognome: Latino
Email: send email
Telefono: +39 02 64485877
Fax: +39 02 64485899

IT (MILANO) participant 288˙180.00
5    PHARMO COOPERATIE UA

 Organization address address: VAN DEVENTERLAAN 30-40
city: UTRECHT
postcode: 3528 AE

contact info
Titolo: Ms.
Nome: Heleen
Cognome: Van Engeland
Email: send email
Telefono: +31 (0) 302345620
Fax: +31 (0) 302345568

NL (UTRECHT) participant 257˙040.00
6    UNIVERSITAET BREMEN

 Organization address address: Bibliothekstrasse 1
city: BREMEN
postcode: 28359

contact info
Titolo: Mr.
Nome: Wolfgang
Cognome: Banasiewicz
Email: send email
Telefono: +49 421 5959622
Fax: +49 421 5959675

DE (BREMEN) participant 254˙700.00
7    UNIVERSITE VICTOR SEGALEN BORDEAUX II

 Organization address address: RUE LEO SAIGNAT 146
city: BORDEAUX CEDEX
postcode: 33076

contact info
Titolo: Prof.
Nome: Nicholas
Cognome: Moore
Email: send email
Telefono: +33 557 571560
Fax: +33 557 574671

FR (BORDEAUX CEDEX) participant 250˙022.00
8    AZIENDA SANITARIA LOCALE DELLA PROVINCIA DI CREMONA

 Organization address address: VIA S SEBASTIANO 14
city: CREMONA
postcode: 26100

contact info
Titolo: Dr.
Nome: Giuseppe
Cognome: Albini
Email: send email
Telefono: +39 0372 497340
Fax: +39 0372 497318

IT (CREMONA) participant 212˙940.00
9    AZIENDA OSPEDALIERA DI PADOVA

 Organization address address: Via Giustiniani 1
city: PADOVA
postcode: 35128

contact info
Titolo: Dr.
Nome: Antonio
Cognome: Giona
Email: send email
Telefono: +39 049 821 1590
Fax: +39 049 821 1593

IT (PADOVA) participant 126˙540.00
10    THE UNIVERSITY OF NOTTINGHAM

 Organization address address: University Park
city: NOTTINGHAM
postcode: NG7 2RD

contact info
Titolo: Mr.
Nome: Paul
Cognome: Cartledge
Email: send email
Telefono: +44 115 951 5679
Fax: +44 115 951 3633

UK (NOTTINGHAM) participant 124˙800.00
11    The Research Institute of the Mc Gill University Health Centre

 Organization address address: GUY STREET 2155
city: MONTREAL
postcode: H3H 2R9

contact info
Titolo: Ms.
Nome: Sasha
Cognome: Lee
Email: send email
Telefono: +1 514 934 1934 42334
Fax: +1 514 943 8270

CA (MONTREAL) participant 0.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

complications    validity    gi    inhibitors    steroidal    database    sos    review    nsaids    estimates    children    gastrointestinal    cardiovascular    least    selective    cv    decision    reviews    models    aspirin    model    comprising    inflammatory    gaps    cox    published    literature    evaluation    clinical    toxic    coxibs    drugs    methodological    decisions    data    treatment    regulatory    anti    nsaid    dose    systematic    risk    health    linked    enzyme    clinicians    observational    databases    ema    cvd    million    safety   

 Obiettivo del progetto (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.'

Introduzione (Teaser)

An EU-funded study aimed to retrospectively assess the safety of non-steroid anti-inflammatory drugs (NSAIDs) through an extensive review of clinical studies. The ultimate goal was to draw conclusions regarding the health risk of NSAIDs and support treatment decisions.

Descrizione progetto (Article)

NSAIDs, such as aspirin and ibuprofen, are a class of drugs with analgaesic and fever-reducing properties. They work by inhibiting the activity of the enzyme cycloogenase I (COX-I), which is implicated in the production of prostaglandins.

Administration of NSAIDs has been linked with a 3- to 5-fold increased risk in serious upper gastrointestinal (GI) complications, driving pharmaceutical development towards selective inhibitors of COX-II enzyme that is more tightly linked with inflammation and pain. However, rofecoxib, one of the most widely used COX-II inhibitors, was withdrawn in 2004 due to its association with an increased risk of cardiovascular (CV) events.

This has triggered the European Medicines Agency (EMA) to initiate two comprehensive review processes on the side-effects and safety of NSAIDs. The 'Safety of non-steroidal anti-inflammatory drugs' (SOS) project was included in the EU-funded research into the evaluation of the GI and CV effects of traditional NSAIDs and COX-II selective NSAIDs (coxibs).

Meta-analysis of a vast array of clinical data and observational studies yielded estimates for GI complications, acute myocardial infarction and stroke, but none for heart failure. Information on dose and duration effects as well as data in children was lacking and several methodological gaps were identified.

The SOS healthcare database study allowed a nested case control study in a cohort of 8.5 million new NSAID users, while addressing many of the gaps that had been identified in the literature. All SOS data were communicated to the EMA to allow for regulatory decision making.

Collectively, this information was utilised to build a decision model for clinicians when choosing the least GI/CV-toxic NSAID. Furthermore, it is expected to extend warning statements concerning CV, GI and skin toxicity in the traditional NSAID product information, with the aim to minimise drug toxic side-effects.

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