They are a group of drugs which millions of people rely on to keep pain at bay but they can have unwanted side-effects which are sometimes more serious than the original health problem. Now scientists at The University of Nottingham are taking part in the largest-ever study on the safety of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) that has ever been performed.
The project is called SOS (Safety Of non-Steroidal anti-inflammatory drugs) and will study the medical information of 35 million people in Europe to assess the incidence and nature of harmful side-effects on the cardiovascular and gastrointestinal systems of patients. It’s hoped the results will lead to better guidance for doctors on how to balance the advantages of prescribing the drugs with the associated risks of heart and digestive problems.
NSAIDS are widely used in medicine for treating pain, inflammation and degenerative diseases like arthritis. The most commonly-used are aspirin and ibuprofen. But their use is associated with an increased risk of minor and serious gastrointestinal complications. It’s estimated that there are thousands of these cases in the European Union every year. Prompted by these problems, a new class of NSAIDS called ‘Coxibs’ have been developed to reduce the risk of this type of side-effect, but the use of these new drugs has since been linked with an increased risk of heart problems such as heart attack and stroke.
Clinicians and scientists now agree that the risk of stomach problems has to be balanced against the risk of cardiovascular interference. Both risks may differ in one person and for the 30 different types of NSAIDS available in the EU. Up to now research studies have been too small to be effective in terms of providing decision models for doctors and drug regulators but it’s hoped this new large survey will result in a much more accurate prescription method to minimize drug-related harm.
Over the next two and a half years, published literature on previous clinical trials and observational studies will be scrutinized to identify any methodological inconsistencies and knowledge gaps and this information will be used to design and carry out an EU-wide observational study. This study will be the biggest of its kind ever undertaken in this field. It will include data from more than 35 million Europeans, taken from existing healthcare databases in the UK, the Netherlands, Germany and Italy. The researchers will use the data to create a variety of decision models to help doctors prescribe the most suitable type of NSAID for a particular patient and lower the risk of unwanted gastrointestinal or cardiovascular side-effects.
The University of Nottingham is working with ten other leading European research institutions on the three-year project which is being funded with a 2.8 million Euros grant from the EC’s 7th Framework Programme. Fundamental to the project is QResearch, a not-for-profit partnership between The University of Nottingham and leading primary care system supplier EMIS, which uses data collected over the past 17 years.
Professor of Clinical Epidemiology and General Practice, Julia Hippisley-Cox, who founded QResearch, said: “The SOS 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”.
• Project website: www.sos-nsaids-project.org
• Erasmus University Medical Centre, Netherlands
• Fundació IMIM, Spain
• University of Nottingham, UK
• Università di Milano-Bicocca, Italy
• Research Triangle Institute, USA
• Universitaet Bremen, Germany
• The Research Institute of the McGill University Health Centre, Canada
• Azienda Ospedaliera di Padova, Italy
• PHARMO Cooperation UA, Netherlands
• Université Victor-Segalen Bordeaux II, France
• Azienda Sanitaria Locale della provincia di Cremona, Italy
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Notes to Editors:
The University of Nottingham is ranked in the UK's Top 10 and the World's Top 100 universities by the Shanghai Jiao Tong (SJTU) and Times Higher (THE) World University Rankings.
More than 90 per cent of research at The University of Nottingham is of international quality, according to RAE 2008, with almost 60 per cent of all research defined as ‘world-leading’ or ‘internationally excellent’. Research Fortnight analysis of RAE 2008 ranks the University 7th in the UK by research power. In 27 subject areas, the University features in the UK Top Ten, with 14 of those in the Top Five.
The University provides innovative and top quality teaching, undertakes world-changing research, and attracts talented staff and students from 150 nations. Described by The Times as Britain's “only truly global university”, it has invested continuously in award-winning campuses in the United Kingdom, China and Malaysia. Twice since 2003 its research and teaching academics have won Nobel Prizes. The University has won the Queen's Award for Enterprise in both 2006 (International Trade) and 2007 (Innovation — School of Pharmacy), and was named ‘Entrepreneurial University of the Year’ at the Times Higher Education Awards 2008.
Nottingham was designated as a Science City in 2005 in recognition of its rich scientific heritage, industrial base and role as a leading research centre. Nottingham has since embarked on a wide range of business, property, knowledge transfer and educational initiatives (www.science-city.co.uk) in order to build on its growing reputation as an international centre of scientific excellence. The University of Nottingham is a partner in Nottingham: the Science City.
QRESEARCH is a non-profit making venture run by an academic research team within the School of Community Health Sciences in collaboration with EMIS — the UK's leading provider of IT systems to GPs. More than 500 EMIS practices, representing around eight million patients, regularly contribute to the database.
The system anonymises and uploads practices' clinical data to the central database. Then, to protect patient confidentiality, the data are further anonymised and the figures are totalled to produce data that are suitable for research. QRESEARCH produces a weekly bulletin for the Health Protection Agency, the independent body that monitors infectious diseases. It also provides information for individual research projects in specific areas.
Further information about QRESEARCH can be found at the following website: http://www.qresearch.org