Our objective was to determine the efficacy and safety of
valdecoxib (a
cyclo-oxygenase 2 inhibitor) in the treatment of
arthritis. Randomised, controlled trials comparing 10 or 20mg
valdecoxib with placebo or non-steroidal anti-inflammatory drugs (
NSAIDs) in patients with active
osteoarthritis or
rheumatoid arthritis. The manufacturer provided clinical trial reports. Data were combined through meta-analysis. Main outcomes were patient global rating of
arthritis,
arthritis pain, Western Ontario and McMaster Universities indices for
osteoarthritis, American College of Rheumatology indices for
rheumatoid arthritis, discontinuation, endoscopic
ulcers, clinically significant upper gastrointestinal or renal events. Nine trials (five in
osteoarthritis, four in
rheumatoid arthritis) were included with 5726 patients. Overall,
valdecoxib 10 and 20mg were superior to placebo and equivalent in efficacy to maximum daily doses of
NSAIDs. Significantly fewer discontinuations because of gastrointestinal adverse events (4% versus 8%), or endoscopic
ulcers of 3mm or more (5% versus 13%) occurred with
valdecoxib compared with
NSAIDs. Clinically significant upper gastrointestinal events occurred in 2/2733 (0.1%) with
valdecoxib compared with 8/1846 (0.4%) with
NSAIDs. Rates of clinically significant renal events were the same (2-3%) for
valdecoxib and
NSAIDs. At an appropriate dose
valdecoxib was as effective as
NSAIDs in
osteoarthritis and
rheumatoid arthritis. There were fewer gastrointestinal adverse event withdrawals and endoscopically detected
ulcers. Convincing evidence of reduced major gastrointestinal adverse events could not be addressed by the trials.