The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamline safety study
designed to compare the cardiovascular safety of celecoxib versus traditional non-selective
Non Steroidal Anti-Inflammatory Drug (NSAID) therapy.Traditional NSAID's are associated with
significant morbidity and mortality from gastrointestinal toxicity. Cyclooxygenase 2
(Cox-2)selective agents are associated with reduced upper gastrointestinal
toxicity.Traditional NSAID's and Cox-2 inhibitors may also be associated with cardiovascular
and renal disorders. Data from both randomised and observational studies suggest that
celecoxib has similar or reduced cardiovascular toxicity when compared to traditional
NSAID's. However, the overall safety balance of a strategy of celecoxib therapy versus a
strategy of NSAID therapy is unknown. The European Medicines Evaluation Agency (EMEA) has
requested that studies of the cardiovascular safety of celecoxib be carried out within the
indicated population of Europe. This study addresses these issues by comparing the
cardiovascular safety of celecoxib therapy with traditional NSAID therapy in the setting of
the EU healthcare system.
As of May 2013, 7300 patients had been randomised, and had accrued an average 4.2 years of
follow up by the end of May 2014.