The EU-funded SOS (Safety of non-steroidal anti-inflammatory drugs) project is working to provide medical professionals with guidance on the risks (both cardiovascular and gastrointestinal) associated with certain painkillers. Ultimately, the project results should help to better protect patients against these side effects. Non-steroidal anti-inflammatory drugs (NSAIDs) help reduce pain and inflammation, and are commonly given to sufferers of arthritis and other degenerative joint diseases. Experts believe, however, that the drugs also account for thousands of digestive problems in the EU each year - complications that are sometimes more serious than the original health condition itself.

'Coxibs' are a new class of NSAIDs developed in response to associated stomach-related side effects. But their use has since been linked to greater risk of heart attack and stroke. Experts caution a balance has to be achieved to ward off both risk extremes.

Thirty different types of NSAIDs are available in the EU, with aspirin and ibuprofen being among the most commonly used. The side effects may be different for any one person and for the variety of NSAIDs on the market which makes accurate drug prescription very difficult.

The SOS project, which has received EUR 2.8 million in funding from the Health theme of the EU's Seventh Framework Programme (FP7), will examine the medical profiles of more than 35 million Europeans from the general population, making it the largest-ever study on NSAID safety.

The project brings together 11 research institutions from Europe and Canada. They are working together to provide clinicians and regulatory authorities (e.g. medical agencies) with decision-making models to guide NSAID selection. More specifically, the results generated by the SOS team will help medical professionals decide which NSAID has the lowest possible gastrointestinal and cardiovascular risk for an individual patient.

Julia Hippisley-Cox, Professor of Clinical Epidemiology and General Practice at the University of Nottingham in the UK, explained that the project "will help quantify and compare the risks of different NSAIDs based on an individual's profile and should help lead patients and doctors make better decisions regarding treatment options."

The team is reviewing literature from clinical trials and observational results to understand current gaps in knowledge and spot any methodological inconsistencies inherent in these studies. The medical information of over 35 million NSAID users will be taken from healthcare databases in Germany, Italy, the Netherlands and the UK. This data will form the basis of several models to produce the knowledge that will ultimately help decision-making in clinical practice.

The SOS consortium is made up of experts from the Erasmus University Medical Centre in the Netherlands, Fundació IMIM in Spain, Universitá di Milano-Bicocca in Italy, Research Triangle Institute in Spain, Universität Bremen in Germany, Research Institute of the McGill University Health Centre in Canada, Azienda Ospedaliera di Padova in Italy, PHARMO Cooperation in the Netherlands, Université Victor-Segalen Bordeaux II in France, Azienda Sanitaria Locale della provincial di Cremona in Italy and the University of Nottingham in the UK.

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