Clinical trial design and patient demographics of the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Study Program: Cardiovascular outcomes with etoricoxib versus diclofenac in patients with osteoarthritis and rheumatoid arthritis

摘要: Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently needed for the treatment of patients with arthritis. However, long-term use such that cyclooxygenase-2 (COX-2) selective inhibitors has been reported to increase cardiovascular risk as compared placebo, whereas long-term, randomized controlled trials assessing traditional NSAIDs versus placebo lacking. The MEDAL program is designed provide a precise estimate relative event rates COX-2 inhibitor etoricoxib in comparison NSAID diclofenac osteoarthritis and rheumatoid consists 3 multinational, randomized, double-blind arthritis comparing (60 or 90 mg daily) (150 daily). All investigator-reported thrombotic events will be adjudicated by an independent panel experts blinded assignment. primary analysis noninferiority confirmed events, defined upper bound 95% CI hazard ratio