EU project assesses the cardiovascular and gastrointestinal risks of
15 July 2009
Medical information of more than 35 million persons from the general
European population will be studied by the SOS (safety of non-steroidal
anti-inflammatory drugs) project with the goal of better guiding
clinicians how to balance the risk of gastrointestinal and
cardiovascular events when prescribing non-steroidal anti-inflammatory
NSAIDs are widely used in medical practice for treating pain,
inflammation and degenerative joint diseases (for instance, arthritis).
The use of traditional NSAIDs, however, is associated with an increased
risk of minor and serious gastrointestinal events.
It is estimated that in the European Union thousands of
gastrointestinal complications are most likely caused by the use of
NSAIDs every year.
A new class of NSAIDs, the Coxibs, has been developed specifically to
minimize the risk of gastrointestinal events. Since their introduction,
however, the use of these newer NSAIDs raised concerns since they may
increase the risk of cardiovascular events, among which myocardial
infarction and ischemic stroke.
Here, the dilemma presents that the risk of gastrointestinal events
has to be balanced against the risk of cardiovascular events. Both risks
may differ in one single subject and for the 30 different NSAIDs that
are available in the EU.
Despite numerous evaluation studies several questions have yet
remained unanswered, which hampers adequate treatment decision making
around the use of individual NSAIDs. Single studies often are too small
to look at all individual NSAIDs, mostly because only a particular set
of NSAIDS is used in one country. Therefore we know very little on
By combining data from different countries, the heterogeneity and
increased sample size are important for risk assessment and comparison
of the different NSAIDs in subgroups such as adults and children.
The SOS project aims to assess and compare the risk of cardiovascular
and gastrointestinal events among NSAIDs users, with the ultimate goal
to differentiate between NSAIDs and thereby providing decision models to
clinicians and regulatory authorities, such as medicines agencies, to
guide the selection process of NSAIDs in clinical practice to minimize
drug related harm.
A thorough review of published literature of clinical trials and
observational studies will be used to identify methodological issues and
knowledge gaps which will be used to design and conduct a multi-country
This study will include data from more than 35 million Europeans,
extracted from existing health care databases in the UK, the
Netherlands, Germany and Italy.
These data will be used for multiple designs to generate knowledge
which will be used to develop decision models to aid decisions in
clinical practice on the type of NSAID that would yield the lowest
gastrointestinal and cardiovascular risk for an individual patient.
Decision models for regulatory agencies will focus on the public health
The SOS project is funded with 2.8 million Euro granted by the
European Commission in the 7th Framework Programme. SOS is coordinated
by Professor Dr. Miriam Sturkenboom of Erasmus University Medical Center
(Netherlands), and carried out by a consortium of 11 leading research
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