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Safety Of non-Steroidal anti-inflammatory drugs – project

National Research Project


Safety Of non-Steroidal anti-inflammatory drugs – project”


The – Safety Of non-Steroidal anti-inflammatory drugs – project aims to asses and compare the risk of cardiovascular and gastrointestinal events of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) with the ultimate goal of providing decision models to clinicians and regulatory authorities, such as medicine agencies.

The strategy to be followed consists on first systematically reviewing and analyzing previously published clinical trials and observational studies. Then, the methodological issues and knowledge gaps will be identified. Subsequently, multi-country observational study will be designed and conducted in existing health care databases in the UK, Netherlands, Germany and Italy. The project partners will provide information of more than 35 million individuals from the general population, including an ample representation of children. This study will be the largest observational study on NSAID safety that has ever been performed and will permit the unique possibility to investigate the effects of several individual NSAIDs. Finally the knowledge generated will allow the development of the aforementioned decision models, which are needed in clinical practice to decide 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.