EU project assesses the cardiovascular and gastrointestinal risks of NSAIDs

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 drugs (NSAIDs).

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 certain NSAIDs.

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 observational study.

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 risk.

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 institutions.

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