• To compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  

• Is to demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  

Aims

The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor celecoxib or to 'usual-care' with their current non-selective NSAID therapy (with or without cyto-protection with ulcer healing drug use in either celecoxib or 'usual-care' limbs).

Trial Design

This trial utilises the Prospective Randomised Open Blinded End point (PROBE) design . Patients with clinically diagnosed osteoarthritis (OA) or rheumatoid arthritis (RA) 60 years of age or more who are free from established cardiovascular disease and who require chronic NSAID therapy will be identified in the setting of primary care. These subjects will then enter a two-week run-in period where they will take celecoxib 200mg once or twice daily. Patients who successfully complete this run in period will be randomised to receive either celecoxib or to continue their previous standard NSAID therapy. They will then be followed up for an average of 2 years in the setting of the National Healthcare system. The study will terminate when sufficient adjudicated events have accrued. A summary is shown in the diagram below.