The Standard Care Versus Celecoxib Outcome Trial

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. Patients 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 4.2 years in the setting of the local National Healthcare system. The study will terminate when 277 adjudicated cardiovascular events have accrued. A summary is shown in the diagram below.

Inclusion criteria

• Subjects 60 years or over Male & Female
• Chronic NSAIDs use for 90 days or more in a 12 month period
• Subjects who have a licensed indication for chronic non-selective NSAID or Celecoxib.
• Eligible for treatment with either Celecoxib or alternative traditional non-selective NSAID.
• Subjects who are willing to consent to their paper and electronic medical records and prescribing data to be accessed.
• Subjects who are willing to be contacted and interviewed by trial investigators.

Exclusion criteria

• Established cardiovascular disease including ischaemic heart disease, Myocardial Infarction, angina or acute coronary syndrome, cerebrovascular disease or cerebrovascular accident or transient ischaemic attack, established peripheral vascular disease and moderate to severe heart failure.