A randomized trial of the efficacy and tolerability of the COX-2 inhibitorrofecoxib vs ibuprofen in patients with osteoarthritis

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit both cycl ooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). It is not known whether a specific inhibitor of COX-2 will provide efficacy in osteoarthritis (OA) comparable with NSAIDs. Therefore, we compared the efficacy and safety of t he rofecoxib, which specifically inhibits COX-2, with those of the NSAID ib uprofen in patients with OA. Objective: To compare the clinical efficacy and tolerability of rofecoxib ( 12.5 and 25 mg once daily) with ibuprofen (800 mg 3 times daily). Methods: A randomized, double-blind trial of 809 adults with OA was conduct ed. Patients with OA in whom the knee or hip was the primary source of pain were randomized to 1 of 4 treatment groups on demonstration of disease act ivity: placebo; rofecoxib, 12.5 or 25 mg once daily; or ibuprofen, 800 mg 3 times daily. Clinical efficacy and safety were monitored during a 6-week t reatment period. Results: Both doses of rofecoxib demonstrated efficacy clinically comparabl e with ibuprofen as assessed by 3 primary end points (pain walking on a fla t surface [Western Ontario and McMaster Universities Osteoarthritis Index], patient global assessment of response to therapy, and investigator global assessment of disease status) according to predefined comparability criteri a. Both rofecoxib doses and the ibuprofen dose provided significantly (P<.0 01) greater efficacy than placebo on all primary end points. Results from s econdary end points were consistent with those of the primary end points. A ll treatments were well tolerated; the overall incidence rates of clinical adverse experiences were not significantly different (P>.05) among the trea tment groups. Conclusion: Rofecoxib was well tolerated and provided clinical efficacy com parable with a high dose of the NSAID ibuprofen.