SOS
Safety Of non-Steroidal anti-inflammatory drugs
| Coordinatore | ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Organization address
address: 's Gravendijkwal 230 contact info |
| 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
| # | ||||
|---|---|---|---|---|
| 1 |
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Organization address
address: 's Gravendijkwal 230 contact info |
NL (ROTTERDAM) | coordinator | 652˙778.00 |
| 2 |
RESEARCH TRIANGLE INSTITUTE
Organization address
address: CORNWALLIS ROAD 3040 contact info |
US (RESEARCH TRIANGLE PARK) | participant | 325˙440.00 |
| 3 |
FUNDACIO IMIM
Organization address
address: Doctor Aiguader 88 contact info |
ES (BARCELONA) | participant | 307˙560.00 |
| 4 |
UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA
Organization address
address: PIAZZA DELL'ATENEO NUOVO 1 contact info |
IT (MILANO) | participant | 288˙180.00 |
| 5 |
PHARMO COOPERATIE UA
Organization address
address: VAN DEVENTERLAAN 30-40 contact info |
NL (UTRECHT) | participant | 257˙040.00 |
| 6 |
UNIVERSITAET BREMEN
Organization address
address: Bibliothekstrasse 1 contact info |
DE (BREMEN) | participant | 254˙700.00 |
| 7 |
UNIVERSITE VICTOR SEGALEN BORDEAUX II
Organization address
address: RUE LEO SAIGNAT 146 contact info |
FR (BORDEAUX CEDEX) | participant | 250˙022.00 |
| 8 |
AZIENDA SANITARIA LOCALE DELLA PROVINCIA DI CREMONA
Organization address
address: VIA S SEBASTIANO 14 contact info |
IT (CREMONA) | participant | 212˙940.00 |
| 9 |
AZIENDA OSPEDALIERA DI PADOVA
Organization address
address: Via Giustiniani 1 contact info |
IT (PADOVA) | participant | 126˙540.00 |
| 10 |
THE UNIVERSITY OF NOTTINGHAM
Organization address
address: University Park contact info |
UK (NOTTINGHAM) | participant | 124˙800.00 |
| 11 |
The Research Institute of the Mc Gill University Health Centre
Organization address
address: GUY STREET 2155 contact info |
CA (MONTREAL) | participant | 0.00 |
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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.