RESUMO
OBJECTIVE: To directly compare the efficacy and safety of etoricoxib, 30 mg once daily, ibuprofen, 800 mg 3 times daily, and placebo for treatment of osteoarthritis (OA) of the hip and knee. PATIENTS AND METHODS: A randomized, double-blind, placebo-controlled trial of patients with OA of the knee or hip was performed between February 2003 and November 2003 in 61 medical centers in the United States. Qualified patients aged 40 to 89 years were randomized to receive placebo, etoricoxib, 30 mg once daily, or ibuprofen, 800 mg 3 times daily, for 12 weeks. Primary efficacy end points Included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales and Patient Global Assessment of Disease Status. Response to treatment was assessed by the time-weighted average change from baseline over 12 weeks. RESULTS: In 528 patients, baseline values for the 3 primary end points ranged from 67.78 to 72.60 mm (0-100 mm visual analog scale). Near-maximal efficacy was achieved by week 2 with both active treatments and sustained over the course of the trial. During the 12-week period, least squares mean changes in the primary end points (Western Ontario and McMaster Universities Osteoarthritis Index and Patient Global Assessment of Disease Status subscales) ranged from -16.53 to -13.55 mm, -27.89 to -23.68 mm, and -26.53 to -22.97 mm in the placebo, etoricoxib, and Ibuprofen groups, respectively. Both etoricoxib and ibuprofen were more effective (P<.001) than placebo for all primary end points. Etoricoxib and ibuprofen treatment responses for the primary end points were determined to be comparable with use of prespecified comparability criteria. Results for all other efficacy end points were consistent with responses observed for the primary end points. Etoricoxib and ibuprofen generally were well tolerated. CONCLUSION: For patients with OA, treatment with etoricoxib, 30 mg/d, is well tolerated and provides sustained clinical effectiveness that is superior to placebo and comparable to ibuprofen, 2400 mg/d.